A minimally invasive approach to sub-conjunctival outflow: 1 year results of an ab-interno gelatin stent along with cataract surgery and a preoperative MMC injection for the treatment of glaucoma

Session Details

Session Title: Glaucoma II

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

Paper Time: 09:26

Venue: Room 17

First Author: : V. Aragno ITALY

Co Author(s): :    G. Consolandi   A. Fea   H. Ansari   E. Ansari   C. Lavin        

Abstract Details

Purpose:

To establish the safety and efficacy of an ab-interno gelatin stent in combination with cataract surgery and a preoperative mitomycin C injection 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 recorded in 75 subjects through 12 months.

Setting:

The study is being conducted in 7 countries (Italy, Germany, Spain, UK, Poland, Austria, and Switzerland) with 20 surgeons. Setting includes both hospital and private practice. The protocol was identical across all sites.

Methods:

In this prospective, non-randomized, multi-center evaluation, safety and efficacy parameters were evaluated using IOP, visual acuity, and assessment of complications. In combination with cataract surgery, a trans-scleral gelatin stent is placed through a clear corneal incision using a preloaded injector similar to an IOL inserter. Once in place, the permanent gelatin implant is designed to connect the anterior chamber to the non-dissected Tenon's and subconjunctival space, thereby creating diffuse dispersion of aqueous while bypassing potential outflow obstructions. Effectiveness was assessed by comparing medicated baseline IOP and glaucomatous medications to postoperative values through 12 months.

Results:

No major adverse events were reported, and 1 patient was converted to a tube shunt at 4 months. The mean preoperative (best medicated) IOP was 21.7 mmHg. The mean postoperative IOPs were: 13.6 mmHg (37% reduction) at 9 months, and 13.0 mmHg (40% reduction) at 12 months. From the preoperative mean of 2.6 (patients not washed out pre-surgery), 9 months medications were reduced by 77% and at 12 months medications were reduced by 62%.

Conclusions:

The clinically proven ab-interno subconjunctival pathway (i.e. trabeculectomy and tube surgeries) combined with the minimally invasive conjunctiva sparing approach of this broadly adoptable implant procedure may provide a safe and effective approach to controlling IOP and reducing medications in patients with glaucoma. The Gelatin Stent may ultimately be the first minimally invasive glaucoma implant to achieve similar IOP reduction as traditional sub-conjunctival drainage procedures without the associated risks.

Financial Interest:

NONE