Comparison Of Surgical Outcomes Between Excisional Goniotomy Using The Kahook Dual Blade And iStent Trabecular Micro-Bypass Stent In Combination With Phacoemulsification

Figures & data

Table 1 Demographic And Baseline Glaucoma Status Data For Subjects By Study Group

		KDB-Phaco	iStent-Phaco	Significance (p)
Subject-level Parameters		N=34	N=40	–
Age (years), mean (SE)		69.1 (1.6)	69.5 (1.4)	0.879
Gender, n (%)	Male	20 (58.8)	22 (55.0)	0.816
	Female	14 (41.2)	18 (45.0)
Ethnicity, n (%)	Caucasian	20 (58.8)	22 (55.0)	0.381
	African-American	25 (73.5)	31 (77.5)
	Asian	4 (11.8)	5 (12.5)
Eye-level Parameters		N=44	N=58
Glaucoma diagnosis, n (%)	Primary open-angle	27 (61.4)	38 (65.5)	0.228
	Combined mechanism	13 (29.5)	10 (17.2)
	Other	4 (9.1)	10 (17.2)
Severity, n (%)	Mild	34 77.3)	37 (63.8)	0.371
	Moderate	10 (22.7)	17 (29.3)
IOP-lowering medications at baseline, n (%)	0	5 (11.4)	12 (20.7)	0.378
	1	11 (25.0)	20 (34.5)
	2	15 (34.1)	15 (25.9)
	3	10 (22.7)	10 (17.2)

Table 2 Intraocular Pressure Outcomes By Treatment Group

	Intraocular Pressure (IOP)
	KDB-Phaco (n=44)				iStent-Phaco (n=58)				Significance (p)**
	n	Mean(SE)	Change From Baseline Mean(SE)	Significance (p)*	n	Mean(SE)	Change From Baseline Mean(SE)	Significance (p)*
Baseline	44	17.2(0.74)	—	—	58	16.7(0.35)	—	—	0.4863
Day 1	44	14.5(0.98)	−2.71(1.15)	0.0234	58	18.3(0.84)	1.65(0.88)	0.0647	0.0040
Week 1	43	17.2(1.09)	−0.09(1.22)	0.9377	56	16.2(0.57)	−0.55(0.56)	0.3321	0.4061
Month 1	38	14.2(0.63)	−2.84(0.99)	0.0068	37	15.3(0.78)	−1.70(0.82)	0.0453	0.2824
Month 3	37	14.8(0.61)	−2.62(0.78)	0.0019	40	14.5(0.58)	−2.18(0.50)	<0.0001	0.6703
Month 6	44	14.8(0.56)	−2.45(0.73)	0.0017	58	14.2(0.41)	−2.48(0.45)	<0.0001	0.3789

Notes: *Within-group IOP change from baseline. **Between-group mean IOP.

Table 3 Medications Outcomes By Treatment Group

	Intraocular Pressure (IOP)
	KDB-Phaco (n=44)				iStent-Phaco (n=58)				Significance (p)**
	n	Mean(SE)	Change From Baseline Mean(SE)	Significance (p)*	n	Mean(SE)	Change From Baseline Mean(SE)	Significance (p)*
Baseline	44	1.9(0.17)	—	—	58	1.4(0.14)	—	—	0.0452
Day 1	44	1.7(0.18)	−0.23(0.14)	0.1148	57	1.3(0.14)	−0.16(0.09)	0.0715	0.1329
Week 1	44	1.3(0.19)	−0.59(0.19)	0.0026	58	1.4(0.14)	−0.07(0.09)	0.4375	0.7187
Month 1	43	1.4(0.19)	−0.49(0.18)	0.0098	51	1.5(0.15)	0(0.07)	1	0.5799
Month 3	43	0.9(0.16)	−0.93(0.18)	<0.0001	54	1.4(0.15)	−0.04(0.07)	0.5977	0.0572
Month 6	44	1.0(0.17)	−0.91(0.20)	<0.0001	58	1.4(0.14)	−0.09(0.10)	0.3738	0.0799

Notes: *Within-group IOP change from baseline. **Between-group mean IOP.

Table 4 Adverse Events By Treatment Group, N (%)

	KDB-Phaco (n=44)n (%)	iStent-Phaco (n=58)n (%)	P value
IOP elevation (steroid response)	8(18.2)	1(1.7)
Cystoid macular edema	2(4.5)	1(1.7)
Hyphema	2(4.5)	0(0)
Total	12 (27.3)	2 (3.4)	<0.002