A prospective randomised US IDE pivotal study of second-generation trabecular micro-bypass stents implanted in conjunction with cataract surgery

Session Details

Session Title: Cataract Surgery & Glaucoma

Session Date/Time: Sunday 23/09/2018 | 14:00-16:00

Paper Time: 14:30

Venue: Room A3, Podium 1

First Author: : T.Samuelson USA

Co Author(s): :                        

Abstract Details

Purpose:

This US IDE pivotal trial evaluates the IOP-lowering efficacy and safety of the second-generation trabecular micro-bypass stents (iStent inject®) implanted in conjunction with cataract surgery compared to cataract surgery alone in subjects with mild to moderate open-angle glaucoma.

Setting:

40 US sites enrolled and randomized subjects for this study.

Methods:

This is a 2-year prospective, randomized, concurrently controlled, parallel groups, US IDE multicenter trial. The study enrolled subjects ≥45 years diagnosed with mild to moderate OAG on 1 to 3 medications with a cataract eligible for surgery. Baseline post-washout mean diurnal IOP of 21-36 mmHg was required in the study eye. Qualified subjects were randomized to implantation with 2 iStent inject stents in conjunction with cataract surgery or cataract surgery alone. Annual medication washouts were performed to assess unmedicated IOP. Key study assessments included: IOP, BCVA, pachymetry, VF, specular microscopy, biomicroscopy, gonioscopy, funduscopy (including ON and C/D ratio), and AEs.

Results:

A total of 505 subjects were randomized. Both efficacy and safety results at Month 24 will be reported on this novel second-generation trabecular micro-bypass stent (iStent inject) at the time of presentation. The primary efficacy endpoint is the proportion of subjects with ≥ 20% reduction in IOP at Month 24 compared to baseline. The secondary efficacy endpoint is IOP reduction from baseline at Month 24.

Conclusions:

This is one of the initial reports of the US IDE pivotal trial on iStent inject. Accordingly, safety and efficacy results will be revealed during the presentation but cannot be disclosed within the deadline date for abstract submission.

Financial Disclosure:

... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented