Standalone Trabeculotomy and Viscodilation of Schlemm’s Canal and Collector Channels in Open-Angle Glaucoma Using the OMNI Surgical System: 24-Month Outcomes

Figures & data

Table 1 Demographic and Baseline Glaucoma Status Data for the Study Sample

Subject-Level Parameters	Value
Number (n)	27
Age, mean (SD, range)	67.3 (6.4, 56–78)
Gender, n (%)
Male	14 (51.8)
Female	13 (48.2)
Ethnicity, n (%)
White	27 (100.0)
Eye-Level Parameters
Number (n)	38
Study eye, n (%)
Right eye	22 (57.9)
Left eye	16 (42.1)
Glaucoma diagnosis, n (%)
Primary open-angle	27 (71.1)
Pseudoexfoliation	11 (28.9)
Cup-disc ratio, mean (SD, range)	0.65 (0.16, 0.3–0.9)
Visual field mean deviation (dB), mean (SD, Min, Max)	−3.51 (2.89, −10.47, 0.54)
Phakic status, n (%)
Phakic	28 (73.7)
Pseudophakic	10 (26.3)
Prior SLT, n (%)	10 (26.3)

Table 2 Intraocular Pressure and Medication Data at Each Time Point

	Baseline	Day 1	Week 1	Month 1	Month 3	Month 6	Month 12	Month 24
Number of eyes (n)	38	38	38	38	38	38	30	26
Mean IOP (SD, range)	24.6 (3.0, 20–32)	12.6 (2.3, 8–21)	13.8 (3.3, 10–26)	14.0 (2.0, 10–18)	14.2 (2.0, 11–22)	14.2 (1.5, 10–17)	14.7 (1.6, 10–18)	14.9 (2.0, 11–18)
Change from baseline (SD)	—	−12.0 (4.0)	−10.8 (4.1)	−10.7 (3.1)	−10.5 (3.5)	−10.4 (3.4)	−10.1 (3.7)	−10.0 (3.2)
Percent change from baseline (SD)	—	−47.9 (11.7)	−43.4 (14.3)	−42.8 (9.2)	−41.6 (10.2)	−41.4 (9.5)	−39.8 (10.6)	−39.6 (9.1)
Significance	—	<0.0001	<0.0001	<0.0001	<0.0001	<0.0001	<0.0001	<0.0001
Mean number of IOP- lowering medications (SD, range)	1.9 (0.7)	0.1 (0.2, 0–1)	0 (0)	0.1* (0.4, 0–2)	0.2** (0.4, 0–2)	0.3^† (0.6, 0–2)	0.4^†† (0.6, 0–2)	0.5^††† (0.7, 0–2)
Change from baseline (SD)	—	−1.8 (0.8)	−1.9(0.7)	−1.8 (0.6)	−1.7 (0.7)	−1.6 (0.9)	−1.4 (1.0)	−1.4 (1.1)
Percent change from baseline (SD)	—	−96.1 (17.9)	−100 (0)	−95.2 (14.4)	−92.5 (21.1)	−80.7 (42.5)	−70.6 (48.3)	−64.1 (57.5)
Significance	—	<0.0001	<0.0001	<0.0001	<0.0001	<0.0001	<0.0001	<0.0001

Notes: *One eye on bimatoprost/timolol fixed combination, 2 eyes on brinzolamide. **One eye on bimatoprost/timolol fixed combination, I eye on bimatoprost, 2 eyes on brinzolamide. ^†One eye on bimatoprost/timolol fixed combination, one eye on latanoprost/timolol fixed combination, 2 eyes on bimatoprost, 3 eyes on brinzolamide, 2 eyes on dorzolamide. ^††One eye on bimatoprost/timolol fixed combination, one eye on latanoprost/timolol fixed combination, 2 eyes on bimatoprost, 1 eye on latanoprost, 5 eyes on brinzolamide, 2 eyes on dorzolamide. ^†††One eye on bimatoprost/timolol fixed combination, one eye on latanoprost/timolol fixed combination, 2 eyes on bimatoprost, 2 eyes on latanoprost, 1 eye on tafluprost, 1 eye on timolol/dorzolamide fixed combination, 2 eyes on brinzolamide.

Table 3 Secondary IOP and Medication Outcomes at Each Study Time Point

	Day 1	Week 1	Month 1	Month 3	Month 6	Month 12	Month 24
Number of subjects (n)	38	38	38	38	38	30	26
Proportion achieving IOP reduction ≥20% compared to baseline (%)	97.4	97.4	100	97.4	97.4	96.7	100.0
Proportion using one fewer medication compared to baseline (%)	92.1	71.1	100	97.4	89.5	83.3	84.6
Proportion medication-free (%)	84.2	13.2	89.5	86.8	76.3	63.3	57.7

Figure 1 Mean IOP at baseline and every postoperative time point. P < 0.0001 for change from baseline at every time point. Error bars denote standard deviation.

Figure 2 Scatterplot of pre-operative intraocular pressure (IOP) versus post-operative IOP. (A) Month 12. (B) Month 24. Small circles represent a single eye. Intermediate circles, 2 eyes. Large circle, 3 eyes. Points below the diagonal represent a reduction in IOP from pre-operative baseline.

Figure 3 Mean IOP-lowering medication use at baseline and every postoperative time point. P < 0.0001 for change from baseline at every time point. Error bars denote standard deviation.