Ab interno canaloplasty combined with trabecular bypass stenting in eyes with primary open-angle glaucoma

Figures & data

Figure 1 (A) VISCO360^® viscosurgical system. Illustration of the device showing a handpiece with a microcatheter, control wheel for advancing and retracting the microcatheter, viscoelastic reservoir/infusion pump and a locking mechanism. Images are sourced from Sight Sciences, http://sightsciences.com and used with permission. (B) The iStent^® GTS100 trabecular bypass system. Images are sourced from Glaukos Corp., https://www.glaukos.com and used with permission.

Table 1 Patient demographics and disease characteristics

Parameter	CE + TM-bypass + canaloplasty	CE + TM-bypass	P-value
N (Patients)	65	65
Age in Years Mean ± SD (Min, Max)	62.6±8.7 (47, 77)	63.3±7.3 (47, 77)	0.6086
Gender  Male n (%)  Female n (%)	37 (57) 28 (43)	38 (58) 27 (42)	1.00
N (Eyes)	86	100
Glaucoma type	POAG (all)	POAG (all)
Previous SLT n (%)	0 (0)	7 (7)	<0.05
Preop IOP in mmHg Mean ± SD	16.6±3.4 (9, 31)	15.1±3.0 (10, 24)	0.1015
Preop number of medications Mean ± SD (Min, Max)	1.4±1.0 (0, 4)	1.2±0.9 (0, 4)	0.1729

Notes: P-values derived from Student’s t-test for continuous variables and Fisher’s exact test for categorical variables.

Abbreviations: CE, cataract extraction; IOP, intraocular pressure; SLT, selective laser trabeculoplasty; POAG, primary open-angle glaucoma; TM, trabecular meshwork.

Figure 2 Mean IOP (±SD) for all follow-up visits for both cohorts. *P<0.05 compared with baseline. Patients were kept on their preop IOP-lowering medication regimens until after their 1-month IOP assessment. N=86 eyes at preop and 1 month visit, 75 for the 3 month visit, and 72 for the 6 month visit for CE + TM-bypass + canaloplasty; N=100 eyes for the preop, 1 month, and 3 month visits, and 94 for the 6 month visit for CE + TM-Bypass.

Abbreviations: CE, cataract extraction; TM-bypass, iStent GTS100; SD, standard deviation; IOP, intraocular pressure.

Figure 3 Percent mean changes in IOP over time for both cohorts. Patients were kept on their preop IOP-lowering medication regimens until after their 1-month IOP assessment. N=86 eyes at 1 month visit, 75 for the 3 month visit, and 72 for the 6 month visit for CE + TM-bypass + canaloplasty; N=100 eyes for the 1 month and 3 month visits, and 94 for the 6 month visit for CE + TM-bypass. *P<0.05 comparing the two treatment groups.

Abbreviations: IOP, intraocular pressure; CE, cataract extraction; TM, trabecular meshwork.

Figure 4 Treatment success defined as: Proportion of eyes with a reduction of ≥20% from baseline and IOP <18 mmHg with the same or fewer numbers of IOP-lowering medications than preop for both cohorts. N=86 eyes at 1 month visit, 75 for the 3 month visit, and 72 for the 6 month visit for CE + TM-bypass + canaloplasty; N=100 eyes for the 1 month and 3 month visits, and 94 for the 6 month visit for CE + TM-bypass. *P<0.05 comparing the two treatment groups.

Abbreviations: IOP, intraocular pressure; CE, cataract extraction; TTM., trabecular meshwork.

Figure 5 Mean number of IOP-lowering meds (±SD) for all follow-up visits for both cohorts. Patients were kept on their preop IOP-lowering medication regimens until after their 1-month IOP assessment. *P<0.0001 compared with baseline; †P<0.001 between groups. Patients were kept on their preop IOP-lowering medication regimens until after their 1-month IOP assessment. N=86 eyes for CE + TM-bypass + canaloplasty; N=100 eyes for CE + TM-bypass.

Abbreviations: SD, standard deviation; IOP, intraocular pressure; TM, trabecular meshwork.

Figure 6 Proportion of eyes on no IOP-lowering medications. Patients were kept on their preop IOP-lowering medication regimens until after their 1-month IOP assessment. N=86 eyes at 3 month and 6 month visit for CE + TM-bypass + canaloplasty; N=100 eyes for the 3 month and 6 month visits for CE + TM-bypass. TM-bypass = iStent GTS100. *P<0.001 comparing the two treatment groups.

Abbreviations: IOP, intraocular pressure; CE, cataract extraction; TM, trabecular meshwork.

Table 2 Adverse events

	CE + TM-bypass + canaloplasty* N (%)	CE + TM-bypass* N (%)
VA loss >2 lines	3 (3)	8 (8)
Inflammation 1 month	5 (6)	4 (4)
Subconjunctival hemorrhage	1 (1)	0 (0)
Dry eye exacerbation	3 (3)	2 (2)
Hyphema	1 (1)	0 (0)
Complications 1 month	2 (2)	3 (3)
Foreign body sensation	1 (1)	2 (2)
Anisometropia	1 (1)	1 (1)
Corneal edema	0 (0)	2 (2)

Notes: *All complications and inflammation resolved by 3 months.

Abbreviations: CE, cataract extraction; TM, trabecular meshwork; VA, visual acuity.