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Original Article
Combined endoscopic cyclophotocoagulation and
phacoemulsication versus phacoemulsication
alone in the treatment of mild to
moderate glaucoma
Michael J Siegel MD,13 Whitney S Boling MD,4,5 Omar S Faridi MD,6 Chirag K Gupta MD,3 Chaesik Kim
BSEE,2 Richard C Boling MD,5 Matthew E Citron DO,1,3,7 Marc J Siegel MD1,3 and Les I Siegel MD1,3
1
Glaucoma Center of Michigan, Southeld, 2Kresge Eye Institute, Wayne State University, Detroit, 3Department of Ophtalmology,
William Beaumont Hospital, Royal Oak, 7Department of Ophthalmology, St. John Providence Hospital-Michigan State University,
Madison Heights, Michigan, 4Glick Eye Institute, Indiana University, Indianapolis, 5Boling Vision Center, Elkhart, Indiana, and
6
Connecticut Eye Physicians and Surgeons, PC., Milford, Connecticut, USA
ABSTRACT
Background: To evaluate the long-term effects of
combined endoscopic cyclophotocoagulation and
phacoemulsification (phaco) versus phacoemulsification alone on intraocular pressure control and
medication reliance in the treatment of mild to moderate glaucoma.
Design: Retrospective chart review in private practice
setting by glaucoma fellowship trained surgeons.
Participants: A total of 261 eyes in the combined
phaco-endoscopic cyclophotocoagulation group with
52 eyes in the phaco-alone group.
Methods: Comparison of phaco-endoscopic cyclophotocoagulation with phaco alone over 36 months.
Main Outcome Measures: Full and qualified success
cumulative survival, intraocular pressure and medication reliance 636 months compared with baseline. Full success was defined as minimum 20%
intraocular pressure reduction with a decrease of at
least one ocular hypertensive medication. Qualified
Correspondence: Dr Michael J Siegel, Glaucoma Center of Michigan, 29201 Telegraph Road, Suite 301, Southeld, MI 48034, USA. Email: msiegel@
med.wayne.edu
Received 7 September 2014; accepted 5 February 2015.
Conflict of interest: None.
Funding sources: None.
Prior Presentation: Abstract/Poster at American Glaucoma Society Annual Meeting, Washington, DC, 2014.
532
ECP and phaco versus phaco alone
INTRODUCTION
Cyclodestructive procedures were first noted to
decrease intraocular pressure (IOP) when Heine
observed IOP lowering with detachments of the
ciliary body in the early 1900s. In the 1950s, Bietti
utilized cyclocryotherapy to reduce IOP.1 Since
then, lasers utilizing either a transcleral or
transpupillary route
have
been
used
for
reduction of IOP. Despite the advantage of IOP
reduction, various cyclodestructive techniques share
common compli- cations including pain, uveitis,
prolonged hypotony, haemorrhage,
choroidal
effusion and
postoperative loss
of
vision.2
Endoscopic cyclophotocoagulation (ECP) is a more
recent and Food and Drug Administration-approved
technique developed by Martin Uram to achieve the
same IOP-lowering ben- efits, but without such an
extensive complication profile.3 This technique
reduces complications as compared with external
cyclodestructive procedures by obtaining direct
visualization of the ciliary epi- thelium so that the
diode laser energy can be deliv- ered
more
precisely, sparing
the
surrounding tissues.24
Several long-term studies have shown that ECP is
both a safe and effective method of lowering IOP,
especially in patients with mild to moderate
medically controlled glaucoma. Many of these
same studies have also demonstrated the efficacy
of ECP on lowering IOP when combined with
phacoemulsification (phaco).46 More
recently,
various studies have shown that there is a long-term
effect on IOP by performing phaco.713 However, in
addition, many of these patients required adjunctive
therapy to achieve any sustained and long-term
benefit on IOP.1113
A recent prospective study by Francis et al. comparing combined phaco-ECP versus phaco alone was
published showing lower IOP and medication reliance in the combined phaco-ECP group versus the
phaco-alone group; this is the only study to date
with comparative data longer than 12 months.14
METHODS
This study conformed to the tenets of the Declaration
of Helsinki and was approved by the institutional
review boards of the affiliated hospitals. A retrospective chart review was performed at two private practice centres, examining 161 patients (313 eyes) in
Siegel et al.
532
Table 1.
Demographic comparison and baseline measures between the phaco-ECP study group and phaco-alone control group
Eyes, n:
Age, y:
Mean
Sex, n (%):
Male
Female
Race, n (%):
Caucasian
African-American
Other
Glaucoma diagnosis, n (%):
POAG
CACG
NTG
Other OAGs
Visual acuity (Snellen):
Median at baseline
Median at 36 months
Optic nerve C : D
Mean SD
Preoperative IOP (mmHg)
Mean SD
Preoperative medications, n
Mean SD
Post hoc study power = 0.94
P-value
261
74.8 8.0
53 (39.5)
81 (60.5)
90 (67.2)
39 (29.1)
5 (3.7)
113 (84.4)
3 (2.2)
13 (9.7)
5 (3.7)
52
78.0 8.1
8 (29.6)
19 (70.4)
18 (66.7)
8 (29.6)
1 (3.7)
15 (55.6)
2 (7.4)
5 (18.5)
5 (18.5)
0.06
0.35
0.10
0.54
20/50
20/30
20/60
20/30
0.10
0.07
0.61 0.15
0.66 0.19
0.07
17.2 4.8
17.7 4.4
0.52
1.3 0.6
1.5 0.7
0.22
Unpaired t-test for IOP and MannWhitney U-test for medications. CACG, Chronic Angle Closure Glaucoma; ECP, endoscopic
cyclophotocoagulation; IOP, intraocular pressure; NTG, Normal Tension glaucoma; OAG, Open Angle Glaucoma; POAG, primary openangle glaucoma; SD, standard deviation.
RESULTS
Our study demonstrated a statistically significant
difference between the combined phaco-ECP group
versus phaco alone in long-term medication reliance
in addition to both full success and qualified success
criteria. The only individual variable that did not
show statistical significance was long-term IOP
reduction when compared between the two cohorts.
However, as mentioned above, when extrapolated
with medication reduction, the combined data was
actually statistically significant.
Mean baseline IOP was 17.2 4.8 mmHg in
the phaco-ECP group and 17.7 4.4 mmHg in the
phaco-alone group. At 36 months, mean IOP in the
combined phaco-ECP group was 14.6 3.1 mmHg,
whereas the phaco-alone group was 15.5
3.6 mmHg, (P = 0.34). Figure 3 demonstrates that
both combined phaco-ECP and phaco alone effectively lowered IOP in the long term when compared
with baseline. Table 2 illustrates that there was not
a statistically significant difference in their IOPlowering efficacy at any postoperative visit. In addition, one can see in Table 3 a comparison of the
percentage change in IOP at each timeframe. Baseline
medication use was 1.3 versus 1.5 medications in the
phaco-ECP group and phaco-alone groups, respectively. At 36 months, Figure 4 illustrates a dramatic
difference in long-term medication reliance. Mean
medication use in the combined phaco-ECP group
was 0.2 0.59 medications; while the phaco-alone
group was 1.3 0.61 medications (P < 0.001). In
ECP + phaco
Phaco only (control)
19
IOP (mmHg)
18
17
16
15
14
13
12
Preoperative 1
12
18
Time (m)
24
30
36
Number of medications
ECP + phaco
Phaco only (control)
1.5
0.5
0
Preoperative 1
12
18
Time (m)
24
30
36
Figure 4. Comparative medication reliance of combined endoscopic cyclophotocoagulation (ECP)-phaco versus phaco alone
from baseline to 36 months.
addition, Table 2 shows that this statistically significant difference was prevalent at every post-operative
visit.
Figure 5 highlights that the combined phaco-ECP
group had a statistically significant greater full
success survival than the phaco-alone group,
(P 0.001). In addition, the combined group also
showed greater long-term qualified success survival
that was also statistically significant as illustrated in
Figure 6, (P 0.001). These statistically significant
results are further elaborated to show the percent
survival at each postoperative visit in Table 4. For
example, at the 18-month postoperative visit, our
Table 2.
Preoperative
6 Months
12 Months
18 Months
24 Months
30 Months
36 Months
P-value
Phaco group
P-value
Phaco group
P-value
17.2 4.8
14.7 3.5
14.7 3.5
14.9 3.1
15.0 3.1
14.8 3.8
14.7 3.1
<0.001
17.7 4.4
16.0 3.3
16.2 3.4
14.4 3.2
14.1 2.9
13.5 2.5
15.5 3.6
<0.001
0.52
0.06
0.17
0.39
0.08
0.11
0.34
1.3 0.6
0.1 0.4
0.2 0.6
0.2 0.5
0.2 0.5
0.2 0.6
0.2 0.6
<0.001
1.5 0.7
1.3 0.8
1.4 1.0
1.4 0.9
1.3 0.9
1.3 0.9
1.3 0.6
<0.001
0.02
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
Unpaired t-test for IOP and MannWhitney U-test for medications. Repeated measures ANOVA. ANOVA, analysis of variance;
ECP, endoscopic cyclophotocoagulation; IOP, intraocular pressure;
Table 3.
Study groups
12
18
24
30
36
4.5 2.2
2.2 4.3
11.5 1.8
3.9 4.0
10.9 1.6
4.4 4.1
9.9 1.6
15.1 3.3
10.3 1.5
15.2 4.4
14.8 1.3
17.2 4.3
12.6 1.4
7.1 5.9
Cum. survival
Cum. survival
1
0.8
1
0.8
0.6
0.6
0.4
0.4
0.2
0 0
ECP + phaco
Phaco only (control)
6
12
0.2
18
Time (m)
24
30
36
0 0
ECP + phaco
Phaco only (control)
6
12
18
Time (m)
24
30
36
Figure 5. Full success cumulative survival analysis from baseline to 36 months. Full success was dened as a minimum
of 20% reduction of intraocular pressure with a decrease in
at least one ocular hypertensive medication. ECP, endoscopic
cyclophotocoagulation.
combined eyes that survived qualified success criteria, and 2.6 times as many combined eyes that
survived full success criteria.
Median preoperative visual acuity was 20/50 in
the phaco-ECP group and 20/60 in the phaco-alone
control group. As noted in Table 1, postoperative
visual acuities were improved and not statistically
different in both groups postoperatively.
Table 4.
Time (months)
12
18
24
30
36
89.1
62.8
97.7
62.8
76.8
32.6
92.2
37.2
69.1
23.3
83.5
27.9
65.0
23.3
80.1
27.9
61.4
23.3
72.6
23.3
Value n (%)
235 (90.03)
21 (8.04)
5 (1.91)
In regards to surgical complications, the phacoECP group numbers are low, with only seven
patients requiring secondary glaucoma procedures,
four patients developing cystoid macular oedema
(CME), two patients developing retinal detachments
and one patient requiring a penetrating keratoplasty.
In the phaco-alone group, one patient developed
CME; no other complications were noted.
Postoperative IOP spikes were rare (Table 5), with
90% of the phaco-ECP patients having no occurrences. Only 21 patients had a single IOP spike
leaving just five with two incidences. These IOP
spikes were treated by temporarily increasing ocular
hypertensive medications and/or steroid drop frequency at the discretion of the surgeon. All resolved
within the 1-month time frame.
DISCUSSION
Multiple studies have confirmed the safety and efficacy of combined ECP and phaco in the treatment of
mild to moderate glaucoma patients.2,46 However,
because long-term comparative data with combined
phaco-ECP versus phaco alone is so scarce, we hope
that our results can add to this slowly growing field
of data on IOP control and medication reliance in
these patients.
Lindfield et al. published 24-month retrospective
non-comparative phaco-ECP data both confirming
the safety profile and efficacy of combined phacoECP. They found after performing phaco-ECP
that IOP was reduced from baseline at every time
interval postprocedure and that this reduction was
statistically significant. Contrary to our study and
others data, Lindfields study did not demonstrate
a significant reduction in
ocular hypertensive
medications.5
As noted in Figure 4 and Table 2, ocular hypertensive medications were reduced at every time frame
postprocedure in the combined phaco-ECP group
and not in the phaco-alone group. When compared
together using both IOP and medication reliance as
full success criteria (Figure 5 and Table 4), the combined phaco-ECP group had, at 36 months, 2.6 times
the success rate as compared with phaco alone
(61.4% to 23.3%). In eyes that survived qualified
success criteria (Figure 6 and Table 4), the phacoalone group contained three times as many failures
as compared with combined phaco-ECP eyes (23.3%
to 72.6%).
What is most significant is that this reduced reliance on medications can have a profound effect on
patient compliance, reduce the financial burden of
needing multiple medications and continue stabilization of the patients glaucoma. Thus, the authors
feel that our data strongly support the growing body
of evidence in the use of ECP in combination with
phacoemulsification as a valid and effective glaucoma treatment modality.
When compared with prior studies, it can be
argued that our full success criteria are more stringent, whereas our qualified success criteria are less
stringent. The most recent study by Francis et al. utilized the TVT study criteria, which classified full
success as: IOP less than 21 mmHg and greater than
5 mmHg and 20% reduction from baseline with no
additional glaucoma medications or glaucoma
surgery or loss of light perception vision.19 Our full
success criteria were defined as a minimum of 20%
reduction of IOP with a decrease in at least one
ocular hypertensive medication. As compared with
TVT, we defined percentage reduction in IOP, not a
range in values. The TVT criteria also do not require
a reduction in ocular hypertensive medication, just
no increase in those medications.
Although it may be more rigorous to satisfy full
success criteria in our study, the TVT results have
been validated and utilized time and time again, thus
providing high-quality evidence that the TVT criteria
is a good indicator of postoperative success. In future
attempts to quantify this comparative data, it may
help to utilize this more proven method.
Despite the consistencies between our data and
existing studies, our study has some limitations.
As discussed earlier and like other prior studies,
our control group of phaco-alone patients who also
carried a diagnosis of mild to moderate glaucoma
was small and required evaluating medical records
at two separate treatment centres with some variance
in demographic patient data. We attempted to reduce
the risk of data variance due to differing cohort sizes
by performing a post-hoc power calculation. This
resulted in a value of 0.94, far above the standard
value of 0.80 that is considered the lowest acceptable
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