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First Author: R.Lindstrom USA
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To establish the safety and efficacy of a minimally-invasive ab-interno subconjunctival implant in reducing IOP and glaucoma medications in patients presenting with cataract surgery and glaucoma. Mean IOP, IOP change, reduction in medications, and safety were recorded in 39 subjects though 24 months.
Surgeries were performed by 12 surgeons (outside the U.S.) in hospital or private surgery centers.
During cataract surgery, a trans-scleral, gelatin implant is placed through a self-sealing corneal incision using a preloaded inserter similar to those used in IOL procedures. Once in place, the permanent implant is designed to connect the anterior chamber to the non-dissected Tenons and subconjunctival space, thereby creating diffuse dispersion of aqueous while bypassing potential outflow obstructions. In this prospective, non-randomized, multi-center evaluation, safety parameters were evaluated using IOP, visual acuity, and assessment of complications. Effectiveness was assessed by comparing baseline IOP and glaucomatous medications to postoperative values through 24 months.
No major adverse events were reported, and no patients were converted to another surgical glaucoma procedure through 24 months. The mean preoperative (best medicated) IOP was 22.5 mmHg. The mean postoperative IOPs were: 15.4 at 9 months, 15.7 at 12 months, 14.8 at 18 months, and 15.1 at 24 months. The mean decrease in IOP was -7.1 (-32% reduction) at 9 months, -6.8 (-30% reduction) at 12 months, -7.7 mmHg (-34% reduction) at 18 months, and -7.4 (-33% reduction) at 24 months. At 9 months anti-glaucomatous medications were reduced by 72% from the preoperative mean of 2.5 (patients not washed out pre-surgery), and by ~60% at 12-24 months.
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 an safe and effective approach to controlling IOP and reducing medications in cataract patients with glaucoma.
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