Canaloplasty and Trabeculotomy Combined with Phacoemulsification for Glaucoma: 12-Month Results of the GEMINI Study

Figures & data

Table 1 Demographic and Baseline Glaucoma Status Data for the Study Sample (N=149)

Parameter	Value (N=149)
Age (yr), mean (SD)	68.3 (8.5)
Gender, n (%)
Female	89 (60)
Male	60 (40)
Race/Ethnicity, n (%)
White	122 (82)
Other	27 (18)
Study Eye, n (%)
Right	74 (50)
Left	75 (50)
Glaucoma Diagnosis n, (%)
Primary open-angle	139 (93)
Pseudoexfoliation	9 (6)
Pigmentary	1 (0.7)
Visual Field Mean Deviation (dB), mean (SD)	−3.7 (3.6)
Visual Field Pattern Standard Deviation (dB), mean (SD)	3.7 (2.6)

Abbreviations: dB, decibels; SD, standard deviation.

Table 2 Intraocular Pressure (IOP) Outcomes at Each Postoperative Study Time Point in per Protocol Population (n=120)

	Month 1	Month 3	Month 6	Month 12
Mean (SD) IOP, mmHg
ALL (n=120)	16.6 (6.6)	15.1 (3.5)	15.2 (4.0)	15.6 (4.0)
POAG only (n=113)	16.6 (6.8)	15.0 (3.5)	15.1 (3.9)	15.4 (3.8)
PXF and PG only (n=7)	18.1 (3.9)	17.0 (2.2)	18.0 (3.6)	19.1 (6.9)
Eyes on 0 meds, n (%)
ALL (n=120)	87 (73)	95 (79)	96 (80)	96 (80)
POAG only (n=113)	82 (73)	90 (81)	90 (80)	90 (80)
PXF and PG only (n=7)	5 (71)	5 (71)	6 (86)	6 (86)
Eyes with decrease in Diurnal IOP ≥20% at Month 12, n (%)
ALL (n=120)	NA	NA	NA	104 (87)
POAG only (n=113)				100 (89)
PXF and PG only (n=7)				4 (57)
Eyes on 0 meds with decrease in IOP ≥20%, n (%)	67 (84)	83 (92)	87 (94)	90 (92)
Eyes on 0 meds with decrease in IOP ≥20% and IOP ≥6 ≤ 18 mmHg, n (%)	60 (75)	79 (88)	82 (88)	85 (87)
Mean (SD) unmedicated IOP, mmHg*	15.6 (5.2)	14.5 (2.9)	14.3 (3.1)	14.6 (3.1)**
Mean (SD) decrease in unmedicated IOP from Baseline*	7.7 (4.7)	8.7 (3.2)	9.0 (3.3)	8.2 (4.1)**
Mean (SD) decrease in unmedicated IOP (%) from Baseline*	34 (19)	37 (12)	39 (12)	34 (16)**

Notes: *Among eyes on no medications at each time point **Unmedicated IOP is measured as mean DIOP.

Abbreviations: mmHg, millimeters of mercury; SD, standard deviation; POAG, primary open-angle glaucoma; PXF, pseudoexfoliation; PG, pigmentary glaucoma.

Figure 1 Mean intraocular pressure at each study time point. Error bars represent standard deviation in per protocol population (n=120).

Table 3 Medication Outcomes at Each Postoperative Study Time Point in per Protocol Population (n=120)

	Month 1	Month 3	Month 6	Month 12*
Mean (SD) number of medications	0.4 (0.8)	0.3 (0.6)	0.3 (0.7)	0.3 (0.9)
Mean (SD) reduction in medications	1.4 (1.2)	1.5 (0.9)	1.5 (1.0)	1.4 (1.1)
Mean percent reduction in medications, %	78	83	83	78
Eyes achieving medication freedom	80 (67)	90 (75)	93 (78)	98 (82)
Of the eyes on 0 meds, eyes with no increase in IOP from Baseline, n (%)	77 (96)	90 (100)	93 (100)	98 (100)
Eyes with no increase in medications, n (%)	114 (95)	119 (99)	119 (99)	116 (97)

Note: *Before mandatory medication washout.

Abbreviations: IOP, intraocular pressure; SD, standard deviation.

Figure 2 Mean medication use at each study visit. Month 12 data are before mandatory medication washout (per protocol dataset, n=120). Error bars represent standard deviation.

Table 4 The Nature and Incidence of Adverse Events

Adverse Event	N (%)	Serious	Device Related	Status
Layered hyphema ≥ 1mm	9 (6%)	No	Yes	Recovered spontaneously without sequel
Intraocular pressure increase ≥ 10 mmHg above baseline at ≥ 1 month	3 (2.0%)	No	Yes	Recovered without sequel with hypotensive medication added
Blepharitis	2 (1.3%)	No	No	Recovered spontaneously without sequel
Clinically significant cystoid macular edema	1 (0.7%)	No	No	Recovered without sequel after topical steroid
Internal Hordeolum	1 (0.7%)	No	No	Recovered without sequel after topical treatment
Keratoconjunctivitis sicca	1 (0.7%)	No	No	Recovered without sequel after topical treatment
Vitreous Hemorrhage	1 (0.7%)	No	No	Recovered spontaneously without sequel
Loss of 2 lines or more BCVA (10 or more ETDRS letters) at or after 3 months postoperative	2 (1.3%)	No	No	VA loss due to PCO; ongoing