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First Author: P.Palmberg USA
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To establish the safety and efficacy of a minimally-invasive, ab-internally placed, trans-scleral drainage implant in refractory glaucoma patients (subjects who had failed medications, as well as a previous trab/tube or cilioablation). Surgery was performed as a stand-alone procedure in 39 subjects, with reduction of IOP and medications, and safety recorded through 24 months.
Surgeries were performed by 8 surgeons (outside the U.S.) in hospital or private surgery centers.
Prospective, open label, multi-center evaluation in which a novel inserter delivered a durable cross-linked collagen tube ab-internally through a mounted 25g needle, creating a trans-scleral connection between the anterior chamber and the subconjunctival space. 39 refractory glaucoma patients (33 POAG, 4 PEX, and 2 Congenital) were seen preoperatively, operatively, and at day 1, week 1, and at months 1, 3, 6, 9, 12, 18 and 24 postoperatively. Effectiveness was assessed by comparing baseline IOP and glaucomatous medications to postoperative values. Safety parameters were evaluated using IOP, visual acuity, and assessment of adverse events. Study enrollment is closed, but follow up continues.
The mean preoperative (best medicated) IOP was 22.9 ±4.3 mmHg. The mean postoperative IOPs were: 14.2 ±4.1 at 12 months, 12.4 ±3.4 at 18 months, and 13.8 ±4.5 at 24 months. The mean decrease in IOP was -8.4 (-38% reduction) at 12 months, -10.2 (-48% reduction) at 18 months, and 8.8 mmHg (-43% reduction) at 24 months. At 12, 18, and 24 months anti-glaucomatous medications were reduced by 65%, 71% and 61%, respectively, from the preoperative median of 3.1 ±1.2 (patients not washed out pre-surgery). No major adverse events were reported, and only 7.7% (3 eyes) required another glaucoma surgical procedure through 24 months.
This procedure combines anterior chamber to subjconjunctival space drainage (as used in gold standard procedures such as trabeculectomy and tubes) with minimally-invasive surgery. The tube has dimensions that create an appropriate trans-scleral pressure drop at normal aqueous flow rates, avoiding either hypotony or a too high pressure, and replacing the need for a scleral flap. The ab interno placement of the tube through a 25g needle mounted on the inserter avoids the need for conjunctival dissection. Being able to avoid scleral and conjunctival dissection, as well as iridectomy, resulted in the observation of minimal post-operative inflammation.
... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, ... travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented