Prospective unmasked randomized evaluation of the iStent inject^® versus two ocular hypotensive agents in patients with primary open-angle glaucoma

Figures & data

Figure 1 GTS400 iStent inject^® and G2-M-IS injector.

Figure 2 G2-M-IS injector.

Table 1 Subject accountability

Visit	Two iStent inject^® n	Two medications n
Screening	94	98
Baseline	94	98
Day 1	94	88
Month 1	93	96
Month 3	94	95
Month 6	93	92
Month 9	94	92
Month 12	94	91

Table 2 Demographics

	Two iStent inject^® (N=94)	Two medications (N=98)
Age (years)
Mean (SD)	64.5 (10.3)	64.3 (9.8)
Range	26–83	39–83
Sex
Male/female	37 (39%)/57 (61%)	48 (49%)/50 (51%)
Race/ethnicity
White	94 (100%)	98 (100%)
Eye
OD/OS	41 (44%)/53 (56%)	47 (48%)/51 (52%)
Lens status
Phakic/pseudophakic	92 (98%)/2 (2%)	95 (97%)/3 (3%)

Abbreviations: OD, right eye; OS, left eye; SD, standard deviation.

Figure 3 Proportion of eyes with an M12 IOP reduction ≥50%, ≥40%, ≥30%, and ≥20%, respectively, for the iStent inject eyes without medication versus the two medications group, with a nonresponder assumption for missing data. A between-group difference was significant (P=0.02) at the ≥50% level of IOP reduction.

Abbreviations: CI, confidence interval; IOP, intraocular pressure; M12, month 12.

Figure 4 Proportion of eyes with an M12 IOP ≤15 mmHg and ≤18 mmHg, respectively, for the iStent inject eyes without medication versus the two-medications group, with a nonresponder assumption for missing data.

Abbreviations: CI, confidence interval; IOP, intraocular pressure; M12, month 12.

Table 3 Mean intraocular pressure and intraocular pressure change by visit – all eyes

IOP	Screening	Baseline washout	Month 1	Month 3	Month 6	Month 9	Month 12
Two iStent inject (N=94)
IOP over time
N	94	94	93	94	93	94	94
Mean (SD)	21.1 (1.7)	25.2 (1.4)	13.3 (4.1)	12.8 (3.2)	12.7 (3.2)	12.9 (2.9)	13.0 (2.3)
IOP change from screening
N			93	94	93	94	94
Mean (SD)			−7.7 (4.2)	−8.3 (3.3)	−8.5 (2.8)	−8.2 (3.0)	−8.1 (2.6)
IOP change from baseline
N			93	94	93	94	94
Mean (SD)			−11.8 (4.2)	−12.4 (3.4)	−12.5 (3.2)	−12.3 (3.0)	−12.2 (2.5)
Two medications (N=98)
IOP over time
N	98	98	96	95	91	92	90
Mean (SD)	20.7 (1.7)	24.8 (1.7)	12.8 (2.6)	12.5 (2.8)	12.2 (2.2)	12.8 (2.9)	13.2 (2.0)
IOP change from screening
N			96	95	91	92	90
Mean (SD)			−7.9 (2.9)	−8.1 (2.6)	−8.3 (2.4)	−7.7 (2.8)	−7.3 (2.2)
IOP change from baseline
N			96	95	91	92	90
Mean (SD)			−12.0 (2.9)	−12.3 (2.8)	−12.6 (2.4)	−11.9 (2.8)	−11.6 (2.2)

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

Table 4 Vertical cup-to-disc ratio change from baseline

	Month 1	Month 3	Month 6	Month 9	Month 12
Two iStents (N=94)
N	92	91	92	93	93
Better (decrease >0.2)	2 (2%)	0 (0%)	0 (0%)	1 (1%)	0 (0%)
No change (change within ±0.2)	89 (97%)	89 (98%)	91 (99%)	89 (96%)	90 (97%)
Worse (increase >0.2)	0 (0%)	1 (1%)	1 (1%)	2 (2%)	1 (1%)
N (missing)	0	2	0	0	0
Two medications (N=98)
N	94	93	92	91	89
Better (decrease >0.2)	1 (1%)	0 (0%)	2 (2%)	0 (0%)	1 (1%)
No change (change within ±0.2)	92 (98%)	92 (99%)	90 (98%)	91 (100%)	88 (99%)
Worse (increase >0.2)	0 (0%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)
N (missing)	1	1	0	0	1

Table 5 Ocular adverse events and other postoperative observations

	iStent inject group (N=94)	Medical therapy group (N=98)
Eye burning	0 (0%)	1 (1%)
IOP decompensation	1 (1%)	0 (0%)
Medication allergy	0 (0%)	1 (1%)
One stent not visible (treated with Nd:YAG laser)	1 (1%)	0 (0%)
Soreness/discomfort	1 (1%)	0 (0%)

Abbreviations: IOP, intraocular pressure; Nd:YAG, neodymium-doped yttrium aluminum garnet.