Early results of a minimally-invasive, ab-interno gelatin stent in combination with a preoperative Mitomycin C injection for the treatment of glaucoma

Session Details

Session Title: Glaucoma I

Session Date/Time: Sunday 14/09/2014 | 08:00-09:30

Paper Time: 08:12

Venue: Auditorium

First Author: : H.Reitsamer AUSTRIA

Co Author(s): :                  

Abstract Details

Purpose:

To establish the safety and efficacy of a minimally-invasive ab-interno gelatin stent in combination with a preoperative mitomycin C injection in reducing IOP and glaucoma medications in patients presenting with glaucoma. Mean IOP, IOP change, reduction in medications, and safety were recorded in 74 subjects through 9 months at the time of this abstract.

Setting:

The study is being conducted in 3 countries (Dominican Republic, Canada, Venezuela) with 3 sites, and 7 surgeons. The protocol is similar across all three sites. It is a prospective, non-randomized study design looking at patients that present with Primary Open Angle, Pigmentary, Pseudoexfoliative, Neovascular, or Ocular Hypertension. The patients are at all various stages of severity including prior failed surgery. Follow-up is at 1 day, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, and 24 month. All sites obtained ethics committee approval and studies are monitored. Not all subjects have reached each post op window and there is not enough statistical data to present past 9 months. Data is being collected during product development and learning curve period.

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 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 currently through 9 months.

Results:

No major adverse events were reported, and no patients were converted to another surgical glaucoma procedure through 9 months. The mean preoperative (best medicated) IOP was 22.3 mmHg ±4.6 mmHg (patients not washed out pre-surgery.) The mean postoperative IOPs were: 15.5 mmHg ±4.9 mmHg at 3 months, 14.9 mmHg ±4.7 at 6 months, and 14.7 mmHg ±5.0 at 9 months. The mean decrease in IOP was -7.5 (-30% reduction) at 3 months, -8.3 mmHg (-33% reduction) at 6 months, and -10.0 (-39% reduction) at 9 months. The preoperative mean of anti-glaucomatous medications the patients were on was 3.2 ±1.1. At 3 months patient’s medications average was 0.5 ±0.3, at 6 months 1.0 ±0.2, and at 9 months 0.8 ±0.2. Early results of the procedure indicate a statistically significant decrease in IOP.

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. Early results of the procedure indicate a statistically significant decrease in IOP.

Financial Interest:

One or more of the authors... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented