Data from 57 eyes of 48 subjects undergoing Phaco-KDB with or without goniosynechialysis and followed for a minimum of 12 months and up to 36 months (mean 26.2 [1.0] months) were analyzed. Demographic and baseline glaucoma status data are given in Table 1. Subjects’ mean age was 64.32 (1.4) years and slightly more were men (56%) than women (44%). Approximately half of the eyes (51%) had primary open-angle glaucoma (POAG), and a quarter each had pseudoexfoliation glaucoma (PXFG) (26%) and angle-closure glaucoma (ACG) (23%).
Table 1. Demographics and baseline glaucoma status in 57 eyes of 48 subjects.
Parameter
|
Value
|
Subject-Level (n=48)
|
Age (yr), mean (SE)
|
64.3 (1.4)
|
Gender, n (%)
|
|
Male
|
27 (56.3%)
|
Female
|
21 (43.8%)
|
Eye-Level (n=57)
|
Follow-up (months), mean (SE)
|
26.2 (1.01)
|
Operative eye, n (%)
|
|
Right
|
33 (58%)
|
Left
|
24 (42%)
|
Glaucoma type, n (%)
|
|
Primary open-angle
|
29 (51%)
|
Pseudoexfoliation
|
15 (26%)
|
Angle closure
|
13 (23%)
|
Cup-disc ratio, mean (SE)
|
0.69 (0.02)
|
SE, standard error
IOP outcomes
IOP data at each time point for the full sample are given in Table 2 and Figure 1. Mean IOP was 20.3 (0.7) mmHg at Baseline and through 36 months of follow-up ranged from 13.5 to 14.0 mmHg (p<0.0002 at all-time points). IOP reductions ranged from 5.8-7.1 mmHg, representing percent IOP reductions of 23.6-29.9%. IOP reductions remained stable throughout follow-up, and at Months 24 and 36 mean IOP was 13.8 (0.3) and 13.7 (0.5) mmHg, respectively. Overall, across all time points, 68.6-77.8% of eyes attained IOP reductions >20%, 93.0-100% attained IOP <18 mmHg, and 72.9-82.5% of eyes attained IOP <15 mmHg (Table 3).
Table 2. Intraocular pressure, medication, and visual acuity data at each time point.
|
Baseline
|
Day 1
|
Week 2
|
Week 4-6
|
Month 2-3
|
Month 6
|
Month 12
|
Month 18
|
Month 24
|
Month 36
|
Number of eyes
|
57
|
57
|
57
|
51
|
57
|
57
|
57
|
51
|
48
|
18
|
Mean (SE) IOP, mmHg
|
20.3 (0.7)
|
14.0 (0.9)
|
13.5 (0.5)
|
14.0 (0.5)
|
14.0 (0.4)
|
13.8 (0.4)
|
13.9 (0.3)
|
13.9 (0.3)
|
13.8 (0.3)
|
13.7 (0.5)
|
Mean (SE) IOP change from baseline, mmHg
|
--
|
-6.4 (1.1)
|
-6.9 (0.9)
|
-5.8 (0.9)
|
-6.3 (0.8)
|
-6.5 (0.8)
|
-6.5 (0.8)
|
-6.5 (0.7)
|
-7.1 (0.7)
|
-6.2 (1.3)
|
Mean (SE) % IOP change from baseline
|
--
|
-25.9 (5.4)
|
-27.8 (4.5)
|
-23.6 (4.1)
|
-25.7 (3.6)
|
-26.1 (3.8)
|
-25.9 (3.7)
|
-26.9 (3.3)
|
-29.9 (3.2)
|
-26.3 (6.0)
|
p (IOP mean change from baseline)
|
--
|
<.0001
|
<.0001
|
<.0001
|
<.0001
|
<.0001
|
<.0001
|
<.0001
|
<.0001
|
0.0002
|
Mean (SE) medications, n
|
3.3 (0.1)
|
0.2 (0.1)
|
0.4 (0.1)
|
0.7 (0.1)
|
1.0 (0.2)
|
1.1 (0.2)
|
1.4 (0.2)
|
1.4 (0.2)
|
1.4 (0.2)
|
1.9 (0.4)
|
Mean (SE) medication change from baseline, n
|
--
|
-3.1 (0.2)
|
-2.9 (0.2)
|
-2.6 (0.2)
|
-2.3 (0.1)
|
-2.2 (0.1)
|
-1.9 (0.1)
|
2.0 (0.2)
|
-2.00 (0.2)
|
-1.3 (0.2)
|
Mean (SE) % medication change from baseline
|
--
|
-94.7 (2.3)
|
-90.5 (2.9)
|
-81.7 (3.5)
|
-74.3 (3.8)
|
-70.9 (3.9)
|
-65 (4.4)
|
-64.6 (4.7)
|
-65.2 (4.9)
|
-51.4 (8.9)
|
P (medication mean change from baseline)
|
--
|
<.0001
|
<.0001
|
<.0001
|
<.0001
|
<.0001
|
<.0001
|
<.0001
|
<.0001
|
<.0001
|
Mean (SE) BCVA, logMAR
|
0.97 (0.11)
|
1.11 (0.14)
|
0.60 (0.08)
|
0.40 (0.07)
|
0.32 (0.05)
|
0.25 (0.04)
|
0.24 (0.04)
|
0.21 (0.03)
|
0.2 (0.03)
|
0.18 (0.06)
|
Mean (SE) BCVA change from baseline, logMAR
|
--
|
0.14 (0.13)
|
-0.37 (0.09)
|
-0.43 (0.07)
|
-0.66 (0.09)
|
-0.72 (0.09)
|
-0.74 (0.09)
|
-0.71 (0.10)
|
-0.69 (0.10)
|
-0.42 (0.10)
|
Mean (SE) % BCVA change from baseline, logMAR
|
---
|
76 (36.1)
|
-15.6 (11.6)
|
-44.8 (8.95)
|
-61.7 (5.79)
|
-72.3 (3.93)
|
-74.4 (3.54)
|
-75.7 (3.77)
|
-76.8 (3.79)
|
-74.1 (8.69)
|
P (BCVA mean change from baseline)
|
---
|
0.2862
|
0.0001
|
<.0001
|
<.0001
|
<.0001
|
<.0001
|
<.0001
|
<.0001
|
0.0005
|
BCVA, best-corrected visual acuity; IOP, intraocular pressure; logMAR, logarithm of the minimum angle of resolution; mmHg, millimeters of mercury; SE, standard error
Table 3. Pre-specified IOP and medication outcomes at each time point.
|
Month 2-3
|
Month 6
|
Month 12
|
Month 18
|
Month 24
|
Month 36
|
Number of eyes (n)
|
57
|
57
|
57
|
51
|
48
|
18
|
Proportion achieving IOP reduction >20% compared to baseline
|
70.2%
|
70.2%
|
71.9%
|
68.6%
|
75%
|
77.8%
|
Proportion achieving IOP <18 mmHg
|
93%
|
93%
|
98%
|
98%
|
97.9%
|
100%
|
Proportion achieving IOP <15 mmHg
|
77.2%
|
82.5%
|
77.2%
|
82.3%
|
72.9%
|
77.8%
|
Proportion using > 1 fewer medication compared to baseline
|
100%
|
100%
|
96.5%
|
98%
|
97.9%
|
88.9%
|
Proportion medication-free
|
50.9%
|
45.6%
|
42.1%
|
41.2%
|
43.7%
|
33.3%
|
IOP, intraocular pressure; mmHg, millimeters of mercury
Medication Outcomes
IOP medication data for the full sample at each time point are given in Table 2 and Figure 2. The mean number of medications used per eye was 3.3 (0.1) at baseline, and through 36 months of follow-up ranged from 0.2 to 1.9 (p<0.0001 at all-time points). Medication reductions ranged from 1.3 to 3.1, representing percent medication reductions of 51.4-94.7%. As anticipated, medication use dropped immediately after surgery and increased gradually throughout follow-up; at Months 24 and 36, mean medication use was 1.4 (0.2) and 1.9 (0.4), respectively. The proportion of eyes attaining >1 medication reduction ranged from 88.9 to 100%, and the proportion that were medication-free ranged from 33.3 to 50.9% at each time point (Table 3).
Visual Acuity Outcomes
Visual acuity data at each time point are given in Table 2. Mean logMAR BCVA was 0.97 (0.11) at baseline and was significantly improved (p< 0.0005 at all-time points after Day 1) through 36 months of follow-up. At Months 24 and 36, mean BCVA was 0.20 (0.03) and 0.18 (0.06), respectively. All eyes but 1 (20/40 preoperatively and 20/50 at Month 36) had improved or stable BCVA at last follow-up.
Outcomes in Subgroups
Mean IOP and IOP-lowering medication reductions from baseline were separately evaluated in the subgroups with POAG, PXFG, and ACG through 24 months of follow-up (Figures 1 and 2). In eyes with POAG, mean IOP reductions were 6.1-7.8 mmHg (25.2-34.5%; p<0.0002 at all-time points), and medication reductions were 1.6-2.9 (59.4-92.2%; p<0.0001 at all time points). At Month 24, mean IOP in eyes with POAG was reduced by 7.8 mmHg (34.5%; p<0.0001) and medications were reduced by 1.2 (55.8%; p=0.0006). In eyes with PXFG, mean IOP reductions were 5.5-6.9 mmHg (18.5-27.2%; p<0.0409 at all-time points), and medication reductions were 2.3 3.1 (74.3-96.7%; p<0.0001 at all-time points). At Month 24, mean IOP in eyes with pseudoexfoliation glaucoma was reduced by 6.4 mmHg (25.6%; p=0.0007) and medication use was reduced by 2.5 (74.3%; p<0.0001). In eyes with ACG, mean IOP reductions were 4.9-7.3 mmHg (18.5-32.7%; p<0.0103 at all-time points except Week 4-6 [18.5%; p=0.0506]), and medication reductions were 2.2-3.6 (63.6-100%; p<0.0001 at all-time points). At Month 24, mean IOP in eyes with ACG was reduced by 6.5 mmHg (25.7%; p=0.0093) and medication use was reduced by 2.3 mmHg (63.6%; p<0.0001). Improvements in BCVA in each subgroup were comparable to the overall sample finding.
Safety Outcomes
The combined procedure was safe and well tolerated. Six eyes (10.9%) developed transient hyphema that resolved spontaneously in all cases, and 1 eye (1.8%) developed elevated IOP on the first postoperative day attributed to retained OVD which also resolved spontaneously. No eyes required any secondary surgical interventions for IOP control throughout the follow-up period.