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June 2004 Pandey et al – Posterior Capsule Opacification 99


Current Ophthalmology

Posterior Capsule Opacification : A Review of the Aetiopathogenesis,


Experimental and Clinical Studies and Factors for Prevention

Suresh K Pandey, MD; David J Apple, MD; Liliana Werner, MD; PhD
Anthony J Maloof, MBBS, MBiomedE, FRANZCO, FRACS;
E John Milverton, MBBS, DO, FRANZCO, FRCOphth

Posterior capsule opacification (PCO, secondary cataract, after cataract) is a nagging postsurgical
complication following extracapsular cataract surgery (ECCE) and intraocular lens (IOL)
implantation. PCO should be eliminated since it has deleterious sequelae and Neodynium:
Yttrium Aluminium Garnet (Nd: YAG) laser treatment often is an unnecessary financial burden
on the health care system. PCO following cataract surgery could be a major problem, since
patient follow-up is difficult and the Nd:YAG laser is not always available. Advances in surgical
techniques, IOL designs/biomaterials have been instrumental in bringing about a gradual and
unnoticed decrease in the incidence of PCO. We strongly believe that the overall incidence of
PCO and hence the incidence of Nd:YAG laser posterior capsulotomy is now rapidly decreasing
– from 50% in the 1980s and early 1990s to less than 10% currently. Superior tools, surgical
procedures, skills and appropriate IOL designs have all helped to significantly reduce this
complication. In this article, we review the aetio pathogenesis, experimental and clinical studies
and propose surgical and implant-related factors for PCO prevention. Careful application and
utilisation of these factors by surgeons could lead to a significant reduction is secondary cataract,
the second most common cause of visual loss worldwide.

Key Words: Intraocular lens, posterior capsule opacification, posterior capsulotomy, secondary
cataract, sealed capsule irrigation.

Indian J Ophthalmol 2004;52:99-112

Opacification of the posterior capsule caused by was particularly common and severe in the early days
postoperative proliferation of cells in the capsular bag of IOL surgery (in the late 1970s and early 1980s) when
remains the most frequent complication of cataract- the importance of cortical cleanup was less appreciated.
intraocular lens (IOL) surgery.1,2 In addition to classic Through the 1980s and early 1990s, the incidence of
posterior capsule opacification (PCO, secondary PCO ranged between 25-50%.9 PCO is a major problem
cataract, after cataract), postoperative lens epithelial cell in paediatric cataract surgery where the incidence
(LEC) proliferation is also involved in the pathogenesis approaches 100%.10-12
of anterior capsule opacification/fibrosis (ACO) and
One of the crowning achievements of modern
inter-lenticular opacification (ILO).3-6 Secondary cataract
cataract surgery has been a gradual, almost unnoticed
(PCO) has been recognised since the origin of
decrease in the incidence of this complication. Our data
extracapsular cataract surgery (ECCE) and was noted
at present show that with modern techniques and IOLs,
by Sir Harold Ridley in his first IOL implantations.7,8 It
the expected rate of PCO and the subsequent
Neodynium: Yttrium Aluminium Garnet (Nd: YAG)
laser posterior capsulotomy rate is decreasing to a single
digit (less than 10%).13,14
Department of Ophthalmology and Visual Sciences, John A.
Moran Eye Center, Utah, USA (SKP, DJA, LW); Western Sydney In this article we review the aetiopathogenesis and
Eye Hospital, Sydney, Australia (AJM), Sydney Hospital and published studies on PCO, and present information that
Sydney Eye Hospitals, Sydney, Australia supports the very optimistic prediction of rapidly
Proprietary Interest: None decreasing incidence of secondary cataract, the second
Correspondence to Dr. Suresh K Pandey, John A. Moran Eye commonest cause of visual loss worldwide. Most of the
Center Fifth Floor, Department of Ophthalmology and Visual information provided in this review is based on several
Sciences, University of Utah, 50 North Medical Drive Salt Lake experimental studies on the pathogenesis and treatment
City, Utah – 841 132, USA. E-mail: <suresh.pandey@hsc.utah.edu> of PCO in our laboratory during the past 20 years, and
Manuscript received: 3.11.03; Revision accepted: 5.5.04 after compiling information from other experimental

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100 INDIAN JOURNAL OF OPHTHALMOLOGY Vol. 52 No. 2

and clinical studies from several centers worldwide. It mitotic activity. In response to a variety of stimuli, the
is hoped that this discussion provides relevant anterior epithelial cells (“A” cells) proliferate and
information and guidance regarding PCO and its undergo fibrous metaplasia. This has been termed
prevention and that it will increase surgeons’ awareness “pseudofibrous metaplasia” by Font and Brownstein.20
of the various tools now available to eradicate this
B. The second zone is important in the pathogenesis
complication.
of “pearl” formation. This layer is a continuation of
anterior lens cells around the equator, forming the
Why Eradicate Posterior Capsule equatorial lens bow (“E” cells). Unlike within the A-cell
Opacification? layer, cell mitoses, division, and multiplication are quite
Although cataract is the most common cause of active in this region. New lens fibres are continuously
blindness in the world, after-cataract (PCO or secondary produced in this zone throughout life.
cataract) is an extremely common cause as well. The In addition to classic PCO, postoperative LEC
eradication of PCO following ECCE has major medical proliferation is also involved in the pathogenesis of
and financial implications: other entities, such as anterior capsule opacification/
1. Nd: YAG laser secondary posterior capsulotomy, fibrosis (ACO)3,4 and ILO; a more recently described
can be associated with significant complications. complication related to piggyback IOLs.5,6 Thus, there
Potential problems include IOL optic damage/pitting, are three distinct anatomic locations within the capsular
postoperative intraocular pressure (IOP) elevation, bag where clinically significant opacification may occur
cystoid macular oedema, retinal detachment, and IOL postoperatively (Figure 1). Ophthalmic researchers are
subluxation.15-18 now developing surgical techniques/devices not only
to eliminate PCO, but also to eliminate capsular bag
2. Dense PCO and secondary membrane formation is opacification, secondary to proliferation of LECs.
particularly common following paediatric IOL
implantation. 10-12 A delay in diagnosis can cause
irreparable amblyopia.
3. PCO represents a significant cost to the health care
system. In the USA. Nd:YAG laser treatments of almost
one million patients per year cost up to $250 million
annually.9
4. A posterior capsulotomy can increase the risk of
posterior segment complications in high myopes and
patients with uveitis, glaucoma, and diabetic
retinopathy.
5. PCO of even a mild degree can decrease near acuity
through a multifocal IOL, and may interfere with the
function of refractive/accommodating IOL designs.
6. A significant incidence of PCO means that cataract
surgery alone may not restore lasting sight to the 25
million people worldwide who are blind from cataract.19 1

7. Finally, a successful expansion of ECCE-IOL


Figure 1. Schematic illustration of the microscopic
surgery in the developing world depends on anatomy of the lens and the capsular bag, showing the “A”
eradication, or at least reduction of PCO, since patient cells of the anterior epithelium and the “E” cells, the
follow-up is difficult and access to the Nd:YAG laser is important germinal epithelial cells of the equatorial lens
not widely available.19 bow. The primary cells of origin for posterior capsule
opacification (PCO) are the mitotic germinal cells of the
Aetiopathogenesis epithelial lens bow. These cells normally migrate centrally
from the lens equator and contribute to formation of the
In the normal crystalline lens, the LECs are confined to
nucleus or epinucleus throughout life. In pathologic states,
the anterior surface at the equatorial region and the
they tend to migrate posteriorly to form such lesions as a
equatorial lens bow. This single row of cuboidal cells
posterior subcapsular cataract, as well as postoperative
can be divided into two different biological zones PCO following ECCE. Beside PCO, postoperative
(Figure 1). proliferation of lens epithelial cells can also lead to
A. The anterior-central zone (corresponding to the postoperative opacification of capsular bag secondary to
zone of the anterior lens capsule) consists of a development of anterior capsule opacification/fibrosis and
monolayer of flat cuboidal, epithelial cells with minimal interlenticular opacifcation;

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June 2004 Pandey et al – Posterior Capsule Opacification 101

Although both types of cells (from the anterior Cell types other than lens epithelial may be involved
central zone and from the equatorial lens bow) have the in PCO. As ECCE is always associated with some
potential to produce visually significant opacification, breakdown of the blood-aqueous barrier, inflammatory
most cases of classic PCO are caused by proliferation of cells, erythrocytes, and many other inflammatory
the equatorial cells. The term posterior capsule mediators may be released into the aqueous humor. The
opacification is actually a misnomer. It is not the capsule severity of this inflammatory response may be
which opacifies; rather, an opaque membrane develops exacerbated by the IOL. This foreign body elicits a three-
as retained cells proliferate and migrate onto the stage immune response that involves many different cell
posterior capsular surface. types, including polymorphonuclear leukocytes, giant
cells, and fibroblasts. Collagen deposition onto the IOL
The opacification usually takes one of two
and the capsule may cause opacities and fine wrinkles to
morphologic forms. One form consists of capsular pearls,
form in the posterior capsule. In most cases, however, this
which can consist of clusters of swollen, opacified
inflammatory response is clinically insignificant. Iris
epithelial “pearls” or clusters of posteriorly migrated
melanocytes also have been shown to adhere to and
equatorial epithelial (E) cells (Bladder or Wedl cells)
migrate over the anterior surface of the posterior capsule.
(Figure 2). It is probable that both LEC types can also
contribute to the fibrous form of opacification. Anterior
epithelial (A) cells are probably important in the
Clinical Manifestations and Treatment
pathogenesis of fibrous PCO, since the primary type of The interval between surgery and PCO varies widely,
response of these cells is to undergo fibrous metaplasia. ranging from three months to four years after the
Although the preferred type of growth of the equatorial surgery. Although the causes of PCO are multifactorial
epithelial (E) cells is in the direction of bloated, swollen, as reported in several studies,9,22,23 there is an inverse
bullous-like bladder (Wedl) cells, these also may correlation with age. Young age is a significant risk
contribute to formation of the fibrous form of PCO by factor for PCO, and its occurrence is a virtual certainty
undergoing a fibrous metaplasia. This is a particularly in paediatric patients.10-12
common occurrence in cataracts in developing world Visual symptoms do not always correlate to the
settings where cataract surgery has been delayed for observed amount of PCO. Some patients with
many years, and where posterior subcapsular cataracts significant PCO on slitlamp examination are relatively
have turned into fibrous plaques (Figure 3).21 asymptomatic while others have significant symptoms
Capsulorhexis contraction (capsular phimosis) is an with mild apparent haze, which is reversed by
important complication related to extreme fibrous capsulotomy.24
proliferation of the anterior capsule. 2-4 Capsular Visually significant PCO is usually managed by
phimosis can be avoided by not making the creating an opening within the opaque capsule using the
capsulorhexis too small. In general, a diameter less than Nd: YAG laser. A surgical posterior capsulotomy may be
5.5 mm is undesirable. indicated in children for dense PCO associated with
In contrast to the lesions of the anterior (A cells) secondary membrane formation. The technical details,
capsule that cause phenomena related to fibrosis, the E parameters, preoperative and postoperative treatment,
cells of the equatorial lens bow (Figure 1) tend to form complications and recommendations for surgical and Nd:
cells that differentiate toward pearls (Bladder cells) and YAG laser posterior capsulotomy are discussed in the
cortex. Equatorial cells (E-cells) are also responsible for literature.15-18 In brief, indications for Nd: YAG laser
formation of a Soemmering’s ring. The Soemmering’s capsulotomy include presence of a thickened capsule
ring, a dumb-bell or donut shaped lesion that often forms leading to functional impairment of vision and the need to
following any type of rupture of the anterior capsule, was evalu-ate and treat posterior segment pathology. However,
first described in connection with ocular trauma. The caution should be exercised if there is any signs suggestive
pathogenetic basis of a Soemmering’s ring is rupture of of intraocular inflammation, raised IOP, macular oedema,
the anterior lens capsule with extrusion of nuclear and and a predisposition to retinal detachment (e.g. high
some central lens material. The extruded cortical myopia). As mentioned before Nd: YAG laser posterior
remnants then transform into Elschnig pearls (Figure 2). capsulotomy may be rarely associated with complications
It is not widely appreciated that a Soemmering’s ring such as transient rise in IOP, enhanced risk of retinal
forms virtually every time any form of ECCE is done, detachment, particularly marked in axial myopia, cystoid
whether manual, automated or with phacoemulsification. macular oedema, IOL subluxation, lens optic damage/
This material is derived from proliferation of the pitting, endophthalmitis, vitreous prolapse into the
epithelial cells (E-cells) of the equatorial lens bow. We anterior chamber and anterior hyaloid disruption.
have noted that these cells have the capability to
proliferate and migrate posteriorly across the visual axis, Six Factors for Prevention of Posterior Capsule
thereby opacifying the posterior capsule. Because the Opacification
Soemmering’s ring is a direct precursor to PCO, surgeons PCO prevention has been our active research interest
should strive to prevent its formation. since 1982. Based upon 20 years of research experience

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102 INDIAN JOURNAL OF OPHTHALMOLOGY Vol. 52 No. 2

2 3a

3a

3b 3c

4a 4b

4c

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June 2004 Pandey et al – Posterior Capsule Opacification 103

on evaluation of around 17,500 IOL related specimens know from autopsy and experimental studies that
(7523 human eyes obtained postmortem; 6127 eyes thorough cortical and cellular cleanup from the capsular
implanted with rigid lenses and 1396 eyes implanted bag can be accomplished in most cases.27 In our study
with foldable lenses) using the Miyake-Apple technique, we demonstrated that use of hydrodissection during
and published studies from our center,1,9,13,14,19,25-30 we have cataract surgery allowed more efficient removal of
reviewed the principles of PCO prevention. These cortex and LECs, (which in turn reduces PCO),
measures can be divided into two categories. One compared to control eyes where hydrodissection was
strategy is to minimise the number of retained/ not utilised (Figure 4).27 Occasionally this can even occur
regenerated LECs and cortex through thorough cortical without the need for cortical aspiration with a separate
cleanup. The second strategy is to prevent the remaining irrigation/aspiration instrument.
LECs from migrating posteriorly. The edge of the IOL
Surgeons use balanced salt solution while
optic is critical in the formation of such a physical barrier.
performing cortical cleaving hydrodissection. Recent
We have identified three surgery-related factors and experimental animal studies from our center have
three IOL-related factors that are particularly important shown that use of preservative-free lidocaine 1% during
in the prevention of PCO (Table 1).25-30 hydrodissection may diminish the amount of live LECs
by facilitating cortical cleanup, loosening the
Surgery-related factors to reduce PCO desmosomal area of cell-cell adhesion with decreased
Hydrodissection-enhanced cortical cleanup: A very cellular adherence, or by a direct toxic effect.33 Corneal
important and underrated surgical step is endothelial toxicity continues to be a major concern of
hydrodissection. Fine perfected and popularised this using hypo-osmolar agents (to loosen the cell-cell
technique and coined the term cortical cleaving adhesion) during hydrodissection or any step of cataract
hydrodissection.31 Until fairly recently, many surgeons surgery, in absence of a sealed capsular bag. However,
had a rather fatalistic attitude towards removal of lens it is now possible to irrigate the entire capsular bag
cortex and cells during (manual / automated – or with using an injection-molded silicone disposable
phacoemulsification). A common opinion was that it innovative device known as Perfect Capsule (Milvella,
removal of all or even most equatorial cells from the Sydney, Australia). Sealed capsule irrigation (SCI)
bag is impossible. PCO was therefore considered an isolates the internal lens capsule, and facilitates removal
inevitable complication.9 of residual cortical material as well as lens epithelial
cells, and thus prevents/delays capsular bag
The necessary tenting up of the anterior capsule opacification.34,35 The SCI technique is pioneered by one
during subcapsular (or cortical cleaving) of us (AJM), and discussed in detail later in this article.
hydrodissection is best achieved by using a cannula
bent at the tip allowing a flow of fluid toward the In-the-bag (capsular) fixation: The hallmark of modern
capsule to efficiently separate capsule from cortex cataract surgery is the consistent and secure in-the-bag
(Figure 4). By freeing and rotating the lens nucleus, (capsular) fixation (Table 1). The most obvious
hydrodissection facilitates lens nucleus and cortex advantage of in-the-bag fixation are the accomplishment
removal without zonular-capsular rupture.32 We now of good optic centration and sequestration of the IOL

Figure 2. Gross photograph from behind (Miyake-Apple posterior photographic technique) of a human eye obtained
postmortem showing massive overgrowth of a Soemmering’s ring over the lens optic. This has created a “pearl form” of total
PCO. This lens was asymmetrically fixated. The left haptic is in the capsular bag. The right haptic (not visible) is in the ciliary
sulcus; Figure 3. A less common form of PCO seen commonly in the developing world consists of a so-called fibrous
plaque. This is sometimes noticed immediately after performing ECCE, and is sometimes termed “acute” PCO. This
represents a pseudofibrous metaplasia of a very long-standing posterior subcapsular cataract. It usually occurs as a result of
delayed treatment; a. Posterior subcapsular plaque in a human eye obtained postmortem (Miyake-Apple posterior
photographic technique); b. Photomicrographs of posterior subcapsular fibrous plaques. The fibrous plaque is the light blue-
staining material adjacent to the posterior capsule (below). A plaque this thin probably does not cause severe visual difficulties;
c. A much thicker plaque (blue-staining region) representing a lesion that could be of clinical significance (Masson’s trichrome
stain, X150); Figure 4a. In our laboratory studies on human eyes obtained postmortem, most cortex and most if not all lens
epithelial cells from the equator (E cells) could be removed with copious hydrodissection and meticulous cortical cleanup,
Gross photograph of experimental surgery on a human cadaver eye from Anterior (surgeon’s) view showing the technique of
subcapsular hydrodissection (cortical cleaving hydrodissection). Note that the 27-gauge bent cannula is immediately under
the edge of the capsulorhexis; b. Photomicrograph of the lens capsular bag of one of the eye that underwent experimental
cataract surgery associated with copious hydrodissection. Note excellent removal of lens material and E cells—a very clear
capsular bag. (Periodic acid-Schiff stain, original magnification x750); c. Photomicrograph of a sagittal view of a crystalline
lens without hydrodissection in human cadaver eyes. Note residual cortical material and equatorial lens epithelial cells.
(Periodic acid-Schiff stain, original magnification 250x).

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104 INDIAN JOURNAL OF OPHTHALMOLOGY Vol. 52 No. 2

Table 1. Six Factors to Reduce PCO*


Surgery-Related Factors IOL-Related Factors
(“Capsular” Surgery) (“Ideal” IOL)

1. Hydrodissection-enhanced cortical clean-up 1. Biocompatible IOL to reduce stimulation of cellular


proliferation
2. In-the-bag fixation
2. Maximal IOL optic- posterior capsule contact, angulated
3. Small CCC with edge on IOL surface haptic, “adhesive” biomaterial to create a “shrink wrap”

3. IOL optic geometry square, truncated edge

*Factors that significantly influence the formation of PCO. Three factors are related to the type and quality of surgery and three are related to
IOL biomaterial/design.

from adjacent uveal tissues. Numerous other Three IOL-Related Factors to Reduce PCO
advantages have been described elsewhere.36,37 This also A. IOL biocompatibility. Lens material biocompatibility
reduces the amount of PCO. (Table 1) is an often-misunderstood term. It can be defined
One desired goal of in-the-bag fixation is enhancing by many criteria, e.g. the ability to inhibit stimulation of
the IOL optic barrier effect. This is maximised when the epithelial cellular proliferation. 38 The less the cell
lens optic stays fully in-the-bag and is in direct contact proliferation the lower the chance for secondary cataract
with the posterior capsule. In case one or both haptics formation. In our large series of postmortem human eyes,
are not placed in the bag, a potential space is created, the Alcon AcrySof“ IOLs presented with minimal to absent
allowing an avenue for cells to grow posteriorly toward Soemmering’s ring formation, PCO and ACO (Figure 5).1-
4,13,14,26,36
the visual axis. The reader may recall the barrier ridge In addition, the amount of cell proliferation is greatly
IOL design of Kenneth Hoffer in the 1980s. This was not influenced by surgical factors, such as copious cortical
favoured at that time.9 The reason was not a problem cleanup. Furthermore, the time factor also plays a role, such
with the concept or the IOLs themselves, but rather that as the duration of the implant in the eye. Additional
only about 30% of posterior chamber IOLs were longterm studies are required to assess the overall role of
implanted inside the bag during this time. “biocompatibility” in the pathogenesis of PCO.

The in-the-bag fixation of IOLs occurs about 60% of B. Maximal IOL Optic-Posterior Capsule Contact.
the time in non-phaco ECCE. In many cases this is due Other contributing factors in reducing PCO are
to combination of rigid design IOLs and can-opener posterior angulation of the IOL haptic and posterior
anterior capsulotomies. With the modern foldable lens convexity of the optic (Table 1). This is due to the
implantation, in-the-bag fixation has increased to over creation of a “shrink wrap”, a tight fit of the posterior
90%. It is not the foldable IOL , or the small incision that capsule against the back of the IOL optic. The relative
has contributed to this success, rather it is the “stickiness” of the IOL optic biomaterial probably helps
meticulous surgery including a continuous curvilinear produce an adhesion between the capsule and IOL
capsulorhexis (CCC) and secures implantation of both optic. There is preliminary evidence that the
IOL loops in the bag.25 hydrophobic acrylic IOL biomaterial provides enhanced
capsular adhesion, or “bioadhesion”. 39-41 This will
Capsulorhexis edge on IOL surface. A less obvious, but require further study.
significant addition to precise in-the-bag fixation, is
creating a CCC diameter slightly smaller than that of the C. Barrier Effect of the IOL Optic. The IOL optic barrier
IOL optic. For example, if the IOL optic were 6.0 mm, the effect (Table 1) plays an important role as a second line
capsulorhexis diameter would ideally be slightly smaller, of defense against PCO, especially in cases where
perhaps 5.0-5.5 mm. This places the cut anterior capsule retained cortex and cells remain following ECCE. The
edge on the anterior surface of the optic, providing a tight concept of the barrier effect goes back to the original
fit (analogous to a “shrink wrap”) and helping to Ridley lens.8 If accurately implanted in the capsular bag,
sequester the optic in the capsular bag from the it provides an excellent barrier effect, with almost
surrounding aqueous humor (Table 1). This mechanism complete filling of the capsular bag and contact of the
may support protecting the milieu within the capsule posterior IOL optic to the posterior capsule (“no space,
from at least some potentially deleterious factors within no cells”). A lens with one or both haptics “out-of-the-
the aqueous, especially some macromolecules, and some bag” has much less of a chance to produce a barrier
inflammatory mediators. The concept of capsular effect. Indeed, the IOL optic’s barrier function has been
sequestration based on the CCC size and shape is subtle, one of the main reasons that PC-IOLs implanted after
but more and more surgeons appear to be applying this ECCE throughout the decades did not produce an
principle and seeing its advantages. unacceptably high incidence of florid PCO.

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June 2004 Pandey et al – Posterior Capsule Opacification 105

A subtle difference between classic optics with a round our large series of eyes obtained postmortem1-4,13,36 have
tapered edge and optics with a square truncated edge helped us develop the above mentioned six factors that
became evident recently (Table 1). The effect of a square- we believe greatly contribute to the reduction of PCO.
edge optic design as a barrier was first discussed by Nishi et Furthermore, an analysis of Nd: YAG laser posterior
al42-44 in articles related to PCO. In a clinicopathological capsulotomy rates among nine commonly used IOL
study, our laboratory confirmed this phenomenon in human models has led us to the optimistic conclusion that the
eyes (Figure 6).27,28 We reported our results of a large incidence of PCO is rapidly diminishing, at least in the
histopathological analysis covering the IOL barrier effect, industrialised world. Table 2 shows the ranking of the
with special reference to the efficacy of the truncated edge Nd: YAG laser posterior capsulotomy rates (%) evaluated
(Figure 6). A truncated, square-edged optic rim appears to in a total of 7523 pseudophakic human eye obtained
cause a complete blockade of cells at the optic edge, postmortem (between January 1988 and July 2002) at our
preventing epithelial ingrowth over the posterior capsule.45- center. Note the lowest percentage of Nd: YAG laser
52
The enhanced barrier effect of this particular edge posterior capsulotomy (at the top) and the relatively
geometry provides another supplemental factor, in addition older, (rigid lenses and early foldable lens designs) had
to the five above-mentioned factors, that has significantly shown higher Nd: YAG laser posterior capsulotomy rate
diminished the overall incidence of clinical PCO. (shown at the bottom of the table [unpublished data]. The
three lenses with the lowest posterior capsulotomy rates
Our past studies 13,14, demonstrated that the original
ranging between 0% and 12.20% are modern designs,
three-piece MA60 AcrySof“ (Alcon Inc., Fort Worth, TX)
mostly implanted after 1992 in contrast to the remaining
IOL successfully combined these three IOL-related factors
six lenses with the higher rates ranging between 20.2%
(Table 1, Figures 5,6) in a way that produced a major PCO
and 31.5%. These were all older designs, already in the
advantage. Other manufacturers have begun to
database prior to 1992. In order to evaluate the influence
incorporate these PCO preventing features, such as a
of lens quality versus the influence of the surgical
sharp, or squared-posterior edge. The Cee-On 911™
technique on the PCO/Nd: YAG laser posterior
silicone IOL (Pfizer Inc., New York, NY) was the first
capsulotomy rates, it is useful to follow a trend-line in
silicone IOL to feature a squared edge. The Sensar™
the longterm. Under optimal conditions, but not possible
hydrophobic acrylic (Advanced Medical Optics Inc., Santa
in this analysis, the information should be viewed
Ana, CA) and Clariflex™ silicone (Advanced Medical
considering the age and the duration of each implant.
Optics Inc, Santa Ana, CA) IOLs now feature a sharp
One of the important limitations in most of the studies of
posterior edge, combined with a rounded anterior edge.
pseudophakic human eyes obtained postmortem from
Modification in the Centerflex‚ one-piece hydrpophilic IOL
our center1-4,13,36, was lack of detailed information such as
design (Rayner Inc., Hove East Sussex, UK) has been
dates of IOL implantation or the time between
incorporated to prevent cellular ingrowth at the broad
implantation and death. These details were difficult to
optic-haptic junction. The modified profile provides a
determine due to ethical considerations. These variables
square edge (barrier, ridge, wall) for 360 degrees around
are going to factor out over time as larger numbers are
the lens optic (enhanced square edge), eliminating the
obtained and the trend “time line” is extended.13
potential defect (Figure 7). This further minimizes the
ingrowth of migrating LECs toward the visual axis.
Confirmation of the six factors in clinical studies
A major disadvantage of the truncated edge is the We would like to cite three studies that confirm the
production of clinical visual aberrations, such as glare, advantage of applying one or more surgical/IOL related
halos and crescents.53 Subtle manufacturing changes in factors to prevent or delay PCO formation. Firstly, a
manufacturing help alleviate glare and other optical clinical study, by Ram and associates 54 confirmed
complications. Figure 8 illustrates scanning electron previous pathological studies demonstrating the
microscopy of the single-piece AcrySof® (SA30AL) IOL importance of in-the-bag fixation of posterior chamber
showing the square (truncated) edge of the optic that had (PC) IOLs (both rigid and foldable) in reducing the
a matte (velvet or ground-glass) appearance, a feature that incidence of PCO. This is true for both standard ECCE
may minimise edge glare and other visual phenomena. and phacoemulsification. This study comprised 278 eyes
Another example of design modification include of 263 patients following ECCE and 318 eyes of 297
introduction of sensar optic Edge‰ IOL manufactured by patients following phacoemulsification with PC IOL
Advanced Medical Optics. This IOL has a squared implantation. The presence of a visually significant PCO
posterior edge and a round anterior edge (Figure 9). (a decrease in Snellen visual acuity of 2 or more lines)
Therefore, it avoids optical dysphotopsias, while retaining and IOL haptic fixation were evaluated postoperatively
the PCO beneficial squared posterior edge. using slitlamp biomicroscopy. Haptic position was noted
as in-the-bag (B-B), 1 haptic in the bag and 1 in the sulcus
Confirmation of Six factors in the Laboratory and (bag-sulcus [B-S]), or both haptics out of the bag (sulcus-
Clinical Studies sulcus [S-S]). In addition, the rate of visually significant
A review of literature.9,22,23,40-52 along with experimental PCO was compared among 3 IOL biomaterials: poly
studies from our center14,27-30 and a complete analysis of methyl methacrylate, silicone, and hydrophobic acrylic.

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5a 5b

6a 6b

7 8

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June 2004 Pandey et al – Posterior Capsule Opacification 107

Visually significant PCO occurred in 42.45% of eyes transparency was higher than in Group 3 (P < .04).
receiving ECCE and 19.18% of eyes receiving Central opacification percentage was lower in Group 1
phacoemulsification (P <.001, chi-square test) after a than in Groups 2 and 3 (P < .04). These authors concluded
mean follow-up of 2.4 ± 0.7 years. In both groups, visually that capsulorhexis with a slightly smaller diameter than
significant PCO was significantly less in eyes with B-B the IOL optic appears to be better than a large-size
fixation than in those with B-S or S-S fixation (P <.001). capsulorhexis in reducing the incidence of PCO.
The rate of visually significant PCO in all eyes in the
Akahoshi has reported his experience of three-piece
phacoemulsification group with B-B fixation was low
AcrySof“ IOL implantation in more than 17,000 human
(11.90%) and was significantly lower in eyes with a
eyes in Japan. The incidence of YAG capsulotomy has
hydrophobic acrylic IOL (2.22%; P <.05, chi-square test).
been found to be 1.19% (207 of 17,329) after 75 months
The results of this study suggested in-the-bag PC IOL
of follow up period. Among the cases treated with Nd:
fixation reduces the incidence of PCO. Thorough removal
YAG laser, 81.2% had an eccentric and incomplete
of lens substance, including hydrodissection-assisted
coverage of the lens optic by the anterior capsulorhexis
cortical cleanup, and in-the-bag PC IOL fixation seem to
margin. In 8.2% of the cases, the anterior capsule margin
be the most important surgical factors in reducing PCO,
was on the optic edge and in 10.6% of the cases it was
regardless of surgical procedure or IOL type used.
completely outside. Longterm follow up revealed that
Ravalico and associates 55 determined the ideal the incidence of after cataract formation in three-piece
capsulorhexis size for minimising the incidence of PCO. AcrySof“ IOLs was extremely low. The size and position
These authors retrospectively evaluated 107 patients who of the CCC, however, seems to be one of the most
had extracapsular cataract extraction with capsulorhexis important factors in reducing the YAG capsulotomy
and capsular bag IOL implantation. The PCO site rate. (T. Akahoshi, Clear corneal cataract surgery and
(central, paracentral, and peripheral) and degree (mild, AcrySof“ implantation. Presented in the ASCRS
moderate, and severe) were evaluated in relation to the Symposium on Cataract, IOL and Refractive Surgery,
capsulorhexis edge location relative to the IOL optic. Boston, MA, April 28, 2001).
Patients were divided into three groups. Group 1:
capsulorhexis free edge located on the IOL optic for 360 Pharmacological Prevention of Posterior Capsule
degrees; Group 2: capsulorhexis free edge located Opacification
asymmetrically on and peripherally to the IOL optic; Intraocular application of pharmacologic agents has also
Group 3: capsulorhexis free edge located peripherally to been investigated by several authors as a means to
IOL optic for 360 degrees. The results of this study prevent PCO.56-61 The idea was to selectively destroy the
demonstrated that in Groups 1 and 2, the capsular LECs and avoid toxic side effects on other intraocular

Figure 5. Among 9 different types of rigid and foldable lens designs studies in psudeophakic human eyes, hydrophobic
acrylic IOLs had the lowest PCO formation and therefore the Nd: YAG laser posterior capsulotomy rates. The lowest PCO
score was confirmed by gross and histological evaluation. a. Human eye obtained postmortem, Miyake-Apple posterior
photographic technique of a single-piece hydrophobic acrylic optic/haptics (Alcon AcrySof“) PC-IOL showing a symmetric
fixation and excellent centration. There is virtually no retained/regenerative material (Soemmering’s ring); b. A 3-piece
acrylic optic/PMMA haptics (Alcon AcrySof“) showing a good example of excellent cortical clean-up, and also suggesting
good biocompatibility, with minimal cellular proliferation; Figure 6. Even when a significant Soemmering’s ring remains in the
eye, a square truncated edge such as what exists on the AcrySof“ IOL provides a second line of defense against cortical
ingrowth. Other IOLs with square or truncated optic edges include the Ciba Mentor MemoryLens‘, the Staar Surgical/Bausch
and Lomb Surgical elastimide-polyimide silicone design, the Pfizer CeeOn Edge‘ 911 silicone IOL, Advanced Medical Optics
Sensar OptiEdge‘ and plate haptic IOLs. Gross photograph from behind (Miyake-Apple posterior photographic technique) of
a human eye obtained postmortem containing an AcrySof® IOL. Some cortical remnants (a Soemmering’s ring) remain
peripherally but the optical zone remains totally cell free, with no encroachment of cells past the edge of the IOL optic.
Photomicrograph of an eye in which an Alcon AcrySof“ IOL was implanted. Cleanup was not complete and a Soemmering’s
ring resulted. However, the Soemmering’s ring remnants (red) were blocked by the square optic edge, leaving the posterior
capsule cell-free. (Masson’s trichrome stain, original magnification x 100); Figure 7. Scanning electron photograph obtained
at the level of the optic-haptic junction of the Rayner Centerflex‘ one-piece hydrpophilic IOL. This profile provides a square
edge (barrier, ridge, wall) for 360 degrees around the lens optic, eliminating the potential defect. The round tapered edge of
classic one-piece IOL design at the optic edge that subtends the optic-haptic junction represents a theoretical in which when
ingrowing cells may bypass the desired barrier; original magnification X 2000 SEM; Figure 8. Scanning electron microscopy
of the single-piece AcrySof® (SA30AL) IOL showed excellent surface finish. Note the square (truncated) edge of the optic
that had a matte (velvet or ground-glass) appearance, a feature that may minimize edge glare and other visual phenomena.
A well-fabricated square or truncated haptic edge was demonstrated original magnification X 2000 SEM; Figure 9. Scanning
electron microscopy of the Advanced Medical Optics Sensar OptiEdge™ IOL design. Note the rounded anterior edge that
scatters the light thus reducing the internal reflection. The sloping side edge minimizes potential for edge glare and the
square posterior edge facilities 360 degree capsular seal original magnification X 2000 SEM.

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10a 10b

10c 10d

11a 11b

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June 2004 Pandey et al – Posterior Capsule Opacification 109

Table 2. Nd: YAG Laser Posterior Capsulotomy Rate (%)* retina of rabbits.62 Results of this study suggested that
January 1, 1988 – July 31, 2002 (Total number of implantation of intracapsular ring may prevent central
pseudophakic human eyes, N=7523) PCO after cataract surgery by mechanically blocking
migration of lens epithelial cells towards the central
IOL Total Nd:YAG YAG%
visual axis. The potential pharmacological effect of 5-
One piece All-Acrylic (AcrySof) 14 0 0% FU for PCO prevention was not demonstrated in this
Three piece Acrylic-PMMA (AcrySof) 470 22 4.70% experimental study.62
Three piece Silicone-PMMA 148 18 12.20% Toxicity to corneal endothelium and other ocular
One piece Silicone Plate, Large Hole 109 22 20.20% structures remains one of the major concerns for using
Three piece Silicone-Polyimide 91 20 22.00% cancer chemotherapeutic drugs, anti-inflammatory
One piece Silicone Plate, Small Hole 155 36 23.20% substances, hypo-osmolar drugs, and immunological
Three piece Silicone-Prolene 409 97 23.70% agents, when the intralenticular compartment is in direct
Three piece PMMA (Rigid) 3781 1158 30.60% contact with the anterior chamber. However, with the
One piece All-PMMA (Rigid) 2346 738 31.50% development of a Sealed Capsular Irrigation (SCI) device,
it is now possible to precisely deliver the
All Lenses since 1/88 7523 2111 28.10%
pharmacological/ hypo-osmolar agents to the lens
Foldable lenses 1396 215 15.40%
epithelial cells within the capsular bag, while minimising
Rigid Lenses 6127 1896 30.90%
the potential for collateral ocular damage.34,35
*These are listed with the highest Nd: YAG laser posterior
capsulotomy rates below. Note that the rigid IOL optic designs had Sealed capsule irrigation of maintaining
the highest rates. The newly introduced foldable IOL designs had
the Nd: YAG laser posterior capsulotomy in single digits (less than postoperative capsular bag transparency
10%).Figure Legends A Sealed Capsule Irrigation device may allow the
isolated safe delivery of pharmacologic agents into the
capsular bag following cataract surgery (Figure 10).34,35
Developed by one of the authors (AJM), SCI is a type of
tissues such as the sensitive corneal endothelium. sealed irrigation system applied to the internal eye. In
Pharmacologic agents being investigated include the eye, the technique of capsular bag irrigation may be
antimetabolites (such as methotraxate, mitomycin, used with pharmacologic agents to target LECs,
daunomycin, 5-FU, colchicine, and daunorubicin), anti- eliminate PCO and help maintain capsular bag
inflammatory substances, hypo-osmolar drugs, and transparency. We consider that SCI should meet the
immunological agents. following requirements: it should be minimally
invasive; be easy to use; fit through a small incision; be
We designed an intracapsular ring to prevent
relatively inexpensive; provide a repeatable seal with
capsular bag contraction and also to inhibit LECs
the lens capsule; and not add significantly to the
proliferation and metaplasia by sustained release of 5-
duration of routine cataract surgery.
FU.62-64 The effects of the intracapsular ring on the
prevention of PCO was prospectively studied by The intact human lens capsule is functionally a
analysing postmortem ocular specimens separate compartment within the eye. Once breached,
macroscopically (using the Miyake-Apple technique65,66) the intralenticular compartment becomes continuous
and histologically. We also evaluated the toxic effects of with the anterior chamber and the rest of the eye. Since
5-FU on the corneal endothelium, capsular bag and an intact capsulorhexis is now routinely performed, we

Figure 10. Schematic diagrams illustrating the concept of Sealed capsule irrigating device (Perfect Capsule,™ Milvella Pty.
Ltd., Sydney, Australia).34,35 This device is designed to hold the capsular bag by means of a toroidal suction ring connected to
a locking suction syringe. An irrigation /aspiration port allows fluids to be injected through the device into the empty capsule,
significantly reducing the concentration of irrigation fluid able to contact other ocular structures and thus perform Sealed
Capsule Irrigation; a. Sealed Capsule Irrigation device viewed from the top. It consists of a round plate that seals against the
capsule and an extension arm that passes outside the wound to provide to the internal lens capsule; b. Sealed Capsule
Irrigation device is folded and inserted through a 3-mm incision; c. Sealed capsule irrigation device is placed onto the
capsular bag and vacuum-activated by a syringe; d. internal irrigation of the capsular bag using Sealed capsule irrigation
device; Figure 11. Clinical photographs showing insertion and capsular irrigation being performed in a human eye using
Sealed Capsule Irrigation (SCI, Perfect Capsule‘); a. Because the device is soft, it folds easily and can be inserted through
a 3.2- to 3.5-mm incision using Kelman-McPherson Forceps (Katena Products, Inc., Denville, NJ, USA) following
phacoemulsification; b & c. The SCI device unfolds instantly in the anterior chamber, resting on the cut edge of the anterior
capsule (capsulorhexis margin); d. The seal and capsule integrity can be tested by inflating the capsule with BSS“, and
confirmed with non leakage of trypan blue (VisionBlue‘, DORC, Zuidland, the Netherlands) from the sealed capsular bag to
the anterior chamber.

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devised a technique to reseal the capsular bag following exposure time of one minute, without adverse damage
lens removal. By resealing the capsular bag, we to any intraocular structure. Ordinarily, exposure of the
recompartmentalise the lens and allow for selective internal rabbit eye to mitomycin 0.02% will lead to
irrigation of the internal contents of the capsular bag. significant toxicity to the retina and cornea, but this did
not occur when SCI was performed.34
The SCI device called Perfect Capsule‘ (Milvella,
Sydney, Australia), made from biomedical grade soft We are continuing to demonstrate that selective
silicone, allows the surgeon to reseal the capsular bag. The capsular bag irrigation can be performed in animals and
device consists of a rounded plate containing a suction ring humans. Using this technique, lens epithelial cells can
which abuts the anterior capsule, and an extension arm be safely targeted to prevent PCO using precise delivery
that passes through a phacoemulsification wound. This of known doses of pharmacologic agents, with less fear
extension arm carries a vacuum channel which supplies of toxicity to surrounding intraocular structures. This
vacuum to the suction ring, and a combined irrigation and method may be utilised to eliminate or modulate LEC
aspiration channel. The irrigation and aspiration channels activity after cataract surgery. This may lead to less
allow for communication between the sealed capsular bag postoperative inflammation and a theoretical reduction
and the external eye. in the risk of postoperative cystoid macular oedema,
We have tested a first generation device on post- reduced anterior and posterior capsule opacification,
mortem porcine lens capsules and demonstrated its and allow for definitive implantation of multifocal and
effectiveness for sealed capsule irrigation.34 We have accommodative lenses so that the treatment of
further refined the device to its current third generation presbyopia may finally become a reality. Clinical studies
form, to incorporate changes which would allow it to will be needed to test efficacy of SCI during paediatric
be used in small incision cataract surgery, and address cataract surgery. Theoretically, SCI may be helpful to
the potential risk of pseudosuction, which would result eliminate of LECs and therefore avoid the PCO/
in loss of sealing of the capsular bag. We considered the secondary membrane formation postoperatively. It may
adult capsule to be less elastic than the paediatric obviate the need for primary posterior capsulotomy
capsule, and less prone to pseudosuction. The device with anterior vitrectomy intraoperatively.
was modified to contain a vacuum manifold within the
There are many potentially beneficial agents which
suction ring such that ensures no focal occlusion of the
may be used with SCI. PCO modulation may be effected
suction ring is not possible at any point, and that the
by apoptosis or deactivation of lens epithelial cells
vacuum is evenly distributed to the entire ring.
rather than cell death or destruction.
To validate this third generation device, 13 randomly
chosen devices were subjected to testing on a pig capsule. Conclusion
In all cases, the devices sealed the capsule using vacuum
The tools, surgical procedures, skills, and appropriate IOLs
generated by a 20mL lockable syringe resulting in a
are now available to significantly reduce PCO. A major
maximal vacuum pressure of greater than 700mmHg on
reduction of Nd: YAG laser capsulotomy rates towards
application, with no evidence of pseudosuction with less
single digits is now possible- because of application of
than 2.5% reduction in vacuum pressure over a one-minute
aforementioned surgical factors and factors related to the
period. One of these devices was then selected for repeat
modern lens designs and the biomaterials. This will
testing for a period of 10 minutes with less than 5%
obviously be of great benefit to the patients in achieving
reduction in vacuum at 10 minutes. The technique of SCI
improved longterm results and in avoiding of Nd: YAG
has also been performed with the third generation device in
laser capsulotomy related complications. Whole one cannot
12 human eyes, using trypan blue to irrigate the capsular
precisely determine the relative proportion or contribution
bag. In all subjects, there was no visible leakage of trypan
of the IOL design vs the surgical techniques to the decrease
blue into the anterior chamber following SCI (Figure 11).34
of Nd: YAG laser rates, this could be possible with
In a study on rabbits, we have been able to selectively continuing analysis including annual updates and
irrigate the capsular bag with mitomycin 0.02% with an increasing numbers of pseudophakic autopsy eyes.

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