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Combined cataract and minimally invasive glaucoma surgery vs minimally invasive glaucoma surgery alone: 1 year results of an ab-interno gelatin stent for the treatment of primary-angle glaucoma

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Session Details

Session Title: Glaucoma I

Session Date/Time: Monday 07/09/2015 | 08:00-10:30

Paper Time: 08:34

Venue: Room 10

First Author: : L.Au UK

Co Author(s): :    C. Lavin   A. Fea   H. Reitsamer              

Abstract Details

Purpose:

To compare the safety and efficacy of an ab-interno gelatin stent, as a stand-alone procedure, or in combination with cataract surgery, in reducing IOP and anti-glaucoma medications in patients presenting with primary open angle glaucoma. Mean IOP, IOP change, reduction in medications, and safety were compared in 69 subjects through 12 months, including 35 cataract and gelatin stent and 34 gelatin stent alone eyes.

Setting:

The study was conducted in conducted in 9 countries (Belgium, Italy, Germany, Spain, UK, Poland, Austria, Canada and Switzerland) with 20+ surgeons. Setting includes both hospital and private practice. The protocol was similar across all sites.

Methods:

In this prospective, non-randomized, multi-center evaluation, safety and efficacy parameters were evaluated. As a stand-alone glaucoma procedure, a trans-scleral gelatin stent is placed through a clear corneal incision using a preloaded injector with a 27 gauge needle. In cataract and gelatin stent patients, the cataract is removed prior to gelatin stent implantation using the same procedure/injector. Once in place, the permanent gelatin implant is designed to connect the anterior chamber to the non-dissected Tenon's and subconjunctival space. Effectiveness and safety was assessed by comparing medicated baseline IOP and glaucomatous medications, and complications at routinely scheduled exams through 12 months.

Results:

The mean preoperative (best-medicated) IOP in the cataract + stent group was 21.7 mmHg compared to 23.6 mmHg in the stent only group. The mean postoperative IOPs were 13.0 mmHg (40% reduction) in the cataract + stent group (n=33), and 12.6 mmHg (47% reduction) in the stent only group (n=33) at 12 months. Anti-glaucoma medications were reduced by 62% in cataract + stent eyes, and by 66% in stent only eyes. No infection, migration or erosion occurred in any patients. 1 cataract + gel stent eye was converted to a tube and 2 stent only eyes were converted to trabeculectomy.

Conclusions:

In this study, the result for the cataract plus stent arm is very good, achieving lower IOP than other phaco plus MIGS products to date. While some evidence suggests phaco plus trabeculectomy is less efficacious than trabeculectomy alone, combine phaco + gel stent appears to produce similar results to gel stent alone. This suggests it is a potentially good option for managing cataract and significant glaucoma where low postop IOP is required.

Financial Interest:

NONE

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