Treatment Success Across Different Levels of Preoperative Disease Burden: Stratified Two-Year Outcomes from the Pivotal Trial of iStent inject^® Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract

Figures & data

Table 1 Preoperative Demographic Characteristics^a of Subjects in the Low-DIOP, Mid-DIOP, and High-DIOP Strata

Parameter		Cataract Surgery with iStent inject (n=387)	Cataract Surgery Only (n=118)
Baseline DIOP <25 mmHg (Low-DIOP)
n		239	76
Age (Years)	Mean ± SD	69.2 ± 8.7	71.2 ± 7.3
	Range	45–98	55–85
Gender	Male	92/239 (38.5%)	32/76 (42.1%)
	Female	147/239 (61.5%)	44/76 (57.9%)
Race/Ethnicity	White	167/239 (69.9%)	55/76 (72.4%)
	Hispanic/Latino	17/239 (7.1%)	7/76 (9.2%)
	Black	52/239 (21.8%)	12/76 (15.8%)
	Asian	3/239 (1.3%)	1/76 (1.3%)
	Other	0/239 (0.0%)	1/76 (1.3%)
Baseline DIOP ≥25 to < 30 mmHg (Mid-DIOP)
n		109	33
Age (Years)	Mean ± SD	68.9 ± 7.5	68.6 ± 8.1
	Range	47–86	52–86
Gender	Male	47/109 (43.1%)	15/33 (45.5%)
	Female	62/109 (56.9%)	18/33 (54.5%)
Race/Ethnicity	White	88/109 (80.7%)	23/33 (69.7%)
	Hispanic/Latino	6/109 (5.5%)	3/33 (9.1%)
	Black	14/109 (12.8%)	6/33 (18.2%)
	Asian	0/109 (0.0%)	0/33 (0.0%)
	Other	1/109 (0.9%)	1/33 (3.0%)
Baseline DIOP ≥30 mmHg (High-DIOP)
n		39	9
Age (Years)	Mean ± SD	67.8 ± 7.4	66.8 ± 8.6
	Range	48–79	46–72
Gender	Male	23/39 (59.0%)	7/9 (77.8%)
	Female	16/39 (41.0%)	2/9 (22.2%)
Race/Ethnicity	White	27/39 (69.2%)	8/9 (88.9%)
	Hispanic/Latino	1/39 (2.6%)	0/9 (0.0%)
	Black	11/39 (28.2%)	1/9 (11.1%)
	Asian	0/39 (0.0%)	0/9 (0.0%)
	Other	0/39 (0.0%)	0/9 (0.0%)

Note: ^a In the intent-to-treat (ITT) population, consisting of all randomized subjects.

Abbreviations: BL DIOP, baseline mean diurnal intraocular pressure; SD, standard deviation.

Table 2 Preoperative Demographic Characteristics^a of Subjects in the Low-Med, Mid-Med, and High-Med Strata

Parameter		Cataract Surgery with iStent inject (n=387)	Cataract Surgery Only (n=118)
1 Ocular Hypotensive Medication at Screening (Low-Med)
n		224	71
Age (Years)	Mean ± SD	68.6 ± 8.0	69.9 ± 8.3
	Range	45–89	46–85
Gender	Male	91/224 (40.6%)	32/71 (45.1%)
	Female	133/224 (59.4%)	39/71 (54.9%)
Race/Ethnicity	White	162/224 (72.3%)	52/71 (73.2%)
	Hispanic/Latino	18/224 (8.0%)	6/71 (8.5%)
	Black	43/224 (19.2%)	11/71 (15.5%)
	Asian	1/224 (0.4%)	1/71 (1.4%)
	Other	0/224 (0.0%)	1/71 (1.4%)
2 Ocular Hypotensive Medications at Screening (Mid-Med)
n		98	30
Age (Years)	Mean ± SD	69.2 ± 7.8	70.7 ± 6.7
	Range	49–88	57–84
Gender	Male	41/98 (41.8%)	15/30 (50.0%)
	Female	57/98 (58.2%)	15/30 (50.0%)
Race/Ethnicity	White	78/98 (79.6%)	22/30 (73.3%)
	Hispanic/Latino	2/98 (2.0%)	2/30 (6.7%)
	Black	16/98 (16.3%)	5/30 (16.7%)
	Asian	1/98 (1.0%)	0/30 (0.0%)
	Other	1/98 (1.0%)	1/30 (3.3%)
≥3 Ocular Hypotensive Medications at Screening (High-Med)
n		65	17
Age (Years)	Mean ± SD	69.6 ± 9.8	69.8 ± 7.2
	Range	47–98	56–86
Gender	Male	30/65 (46.2%)	7/17 (41.2%)
	Female	35/65 (53.8%)	10/17 (58.8%)
Race/Ethnicity	White	42/65 (64.6%)	12/17 (70.6%)
	Hispanic/Latino	4/65 (6.2%)	2/17 (11.8%)
	Black	18/65 (27.7%)	3/17 (17.6%)
	Asian	1/65 (1.5%)	0/17 (0.0%)
	Other	0/65 (0.0%)	0/17 (0.0%)

Note: ^aIn the intent-to-treat (ITT) population, consisting of all randomized subjects.

Abbreviation: Med, medication; SD, standard deviation.

Figure 1 Proportion of Subjects with 24-Month Medication-Free Mean Diurnal Intraocular Pressure (DIOP) Reduction ≥20% from Baseline, Stratified By Baseline DIOP.

Figure 2 Average 24-Month Medication-Free Mean Diurnal Intraocular Pressure (DIOP) Change from Baseline, Stratified By Baseline DIOP.

Figure 3 Proportion of Subjects with 24-Month Medication-Free Mean Diurnal Intraocular Pressure (DIOP) Reduction ≥20% from Baseline, Stratified By Number of Ocular Hypotensive Medications at Screening.

Figure 4 Average 24-Month Medication-Free Mean Diurnal Intraocular Pressure (DIOP) Change from Baseline, Stratified By Number of Ocular Hypotensive Medications at Screening.