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First Author: J.Batlle DOMINICAN REPUBLIC
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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 for 24 months.
Surgeries were performed at Centro Laser in Santo Domingo by 12 different surgeons during the pilot phase.
All the cases in this study were chosen without previous conjunctival surgery. The implant is injected through a novel device that acts as trocar and plunger via a self-sealing corneal wound, and preferably introduced into an avascular and superonasal area of the eye. In phakic eyes, the chamber is filled with cohesive viscoelastic and the delivery guided by gonioscopic confirmation to a target zone 3 mm from the limbus. In cases combined with cataract surgery, the trans-scleral, cross-linked collagen implant is placed through a self-sealing corneal incision using a preloaded inserter. The device is injected after the phacoemulsification procedure is completed under cohesive viscoelastic. 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 evaluation, safety parameters such as IOP, visual acuity and complications were evaluated. Effectiveness was assessed by comparing baseline IOP and glaucomatous medications to post-operative values for 24 months. All cases received a sub-conjunctival injection of 20 mcgs of Mitomycin-C with lidocaine 1% injected away from the target site and jelly-rolled to the nasal area 20 minutes before implantation of the device.
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 a safe and effective approach to controlling IOP and reducing medications in cataract patients with glaucoma.
... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, ... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, ... receives consulting fees, retainer, or contract payments from a competing company