12 month results from a minimally invasive, 45μm lumen ab-interno gelatin stent in combination with a preoperative MMC in open angle glaucoma with and without concurrent cataract surgery: a multicenter prospective study conducted in Spain

Session Details

Session Title: Glaucoma II

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

Paper Time: 09:20

Venue: Room 17

First Author: : M.Teus SPAIN

Co Author(s): :    C. Lavin   L. Cadarso   J. Vila              

Abstract Details

Purpose:

To establish the safety and efficacy of a minimally-invasive ab-interno 45μm lumen gelatin stent in combination with a preoperative mitomycin C injection in reducing IOP and glaucoma medications in Spanish patients presenting with open angle glaucoma (OAG). Mean IOP, IOP change, reduction in medications, and safety were recorded prospectively in 57 subjects through 12 months. Cases with and without concurrent cataract surgery were analyzed.

Setting:

The study is being conducted in 3 different centers. Setting includes both hospital and private practice following an identical protocol in mild to moderate OAG a patients.

Methods:

In combination with cataract surgery or as a standalone procedure, a six millimeter long trans-scleral gelatin (45μm lumen) stent is placed through a self-sealing corneal incision using a preloaded injector. Just prior to implantation, a low dose of MMC (10-20ug) is injected into the superior nasal quadrant. Once in place, the permanent implant is designed to connect the anterior chamber to the non-dissected Tenon's and subconjunctival space, creating diffuse dispersion of aqueous while bypassing potential outflow obstructions. In this prospective, non-randomized, safety and efficacy parameters were evaluated using IOP, visual acuity, and assessment of complications.

Results:

The mean preoperative (best medicated) IOP was 20.9 ± 4.7 mmHg. The mean postoperative IOPs were: 12.1 ± 2.9 at 9 months and 12.3 ± 3.8 at 12 months. The mean decrease in IOP was -8.6 mmHg (-42% reduction) and -8.5 (-41% reduction) at 9 and at 12 months respectively (p<0.05). At 9 months anti-glaucoma medications were reduced by 73% from the preoperative mean of 2.3, and by 52% at 12 months. No major adverse events were reported, however, one patient was converted to trabeculectomy by 12 months. Not all patients have reached the 12 month exam and follow up continues.

Conclusions:

The preliminary results in Spain for this sub-conjunctival gelatin implant are promising and seem to provide a relatively safe method for controlling IOP in patients with open-angle glaucoma with and without concurrent cataract surgery. In eyes with longer follow up, there appears to be a sustained IOP lowering effect of this implant. Long term data to follow.

Financial Interest:

NONE