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1 year results of an ab-interno gelatin stent in combination with mitomycin C for the treatment of glaucoma

Poster Details

First Author: E.Ansari UK

Co Author(s):                  

Abstract Details

Purpose:

To establish the safety and efficacy of a minimally-invasive ab-interno gelatin stent in combination with mitomycin C in reducing IOP and glaucoma medications in patients presenting with glaucoma. Mean IOP, IOP change, reduction in medications, and safety were recorded in 144 subjects through 12 months. Cataract surgery and lens implant was performed concurrently. In this prospective, non-randomized, multi-center study, outside of the USA, safety and efficacy parameters were evaluated using IOP, visual acuity, and safety. Patients were diagnosed with moderate to severe glaucoma. Types of Glaucoma included POAG, Pigmentary, and Pseudoexfoliative.

Setting:

Maidstone & Tunbridge Wells NHS Trust, Kent, UK

Methods:

In combination with cataract surgery or as a standalone procedure, a trans-scleral gelatin stent is placed through a self-sealing corneal incision using a preloaded injector similar to those used in IOL procedures. Once in place, the permanent 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 baseline IOP and glaucomatous medications to postoperative values through 12 months.

Results:

No serious adverse events were reported, and 3 patients were converted to Tube (1)/Trabeculectomy(2) procedure through 12 months. The mean preoperative (best medicated) IOP was 22.2 mmHg. The mean postoperative IOPs were: 14.9 at 6 months, 14.7 at 9 months, and 13.6 at 12 months. The mean decrease in IOP was -8.1 (-33% reduction) at 6 months, -8.1 mmHg (-34% reduction) at 9 months, and -9.6 (-38% reduction) at 12 months. At 6 and 9 month visits anti-glaucomatous medications were reduced by 69% from the preoperative mean of 3.1 (patients not washed out pre-surgery), and by ~63% at 12 months.

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. It can be safely performed together with cataract surgery.

Financial Disclosure:

NONE

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