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First Author: H.Reitsamer AUSTRIA
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To establish the safety and efficacy of the minimally-invasive ab-interno subconjunctival implant in reducing IOP in mild, moderate and severe open angle glaucoma patients. 121 subjects from 18 surgeons were followed for two years, and their outcomes for mean IOP, IOP change, reduction in medications, and safety were recorded.
Surgeries were performed by 18 surgeons (outside the U.S.) in hospital or private surgery centers.
Prospective IRB approved evaluation in which a novel minimal-invasive inserter deposits a permanent, gelatin, trans-scleral aqueous drainage tube which connects the anterior chamber to the subjconjunctival space. The dimensions and mechanical attributes of the material are designed to create a gentle and diffuse dispersion of aqueous into the non-dissected Tenons and subconjunctival space. Effectiveness was assessed by comparing baseline IOP and glaucomatous medications to postoperative values through 24 months (enrollment closed, follow up ongoing). Safety parameters were evaluated using IOP, frequency of patients with loss of visual acuity, and assessment of any adverse events.
The mean preoperative (best medicated) IOP was 21.9 ±3.4 mmHg. The mean postoperative IOPs were: 15.5 ±3.4 at 12 months, 14.0 ±3.4 at 18 months, and 14.6 ±3.1 at 24 months. The mean decrease in IOP was -6.5 (-28% reduction) at 12 months, -8.2 (-35% reduction) at 18 months, and -7.8 mmHg (-33% reduction) at 24 months. At 12 and 18 months anti-glaucomatous medications were reduced by > 65% from the preoperative median of 2.7 ±1.3 (patients not washed out pre-surgery), and by >55% at 24 months. No major adverse events were reported, and only 6% (7 eyes) had another surgical glaucoma procedure by 24 months.
This minimally-invasive procedure is a safe and effective approach for controlling IOP and reducing glaucoma medications in early through refractory glaucoma patients. Bypassing all potential outflow obstructions, the ab-interno approach obviates the need for a scleral flap thus reducing complications associated with traditional glaucoma surgery.
... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented