Purpose To evaluate the effectiveness of an ab interno subconjunctival gelatin implant as primary surgical intervention in reducing intraocular pressure (IOP) and IOP-lowering medication count in medically uncontrolled moderate primary openangle glaucoma (POAG). Methods In this prospective, non-randomized, open-label, multicenter, 2-year study, eyes with medicated baseline IOP 18-33 mmHg on 1-4 topical medications were implanted with (phaco + implant) or without (implant alone) phacoemulsification. Changes in mean IOP and medication count at months 12 (primary outcomes) and 24, clinical success rate (eyes [%] achieving ≥ 20% IOP reduction from baseline on the same or fewer medications without glaucoma-related secondary surgical intervention), intraoperative complications, and postoperative adverse events were assessed. Results The modified intent-to-treat population included 202 eyes (of 218 implanted). Changes (standard deviation) in mean IOP and medication count from baseline were − 6.5 (5.3) mmHg and − 1.7 (1.3) at month 12 and − 6.2 (4.9) mmHg and − 1.5 (1.4) at month 24, respectively (all P < 0.001). Mean medicated baseline IOP was reduced from 21.4 (3.6) to 14.9 (4.5) mmHg at 12 months and 15.2 (4.2) mmHg at 24 months, with similar results in both treatment groups. The clinical success rate was 67.6% at 12 months and 65.8% at 24 months. Overall, 51.1 (12 months) and 44.7% (24 months) of eyes were medication-free. The implant safety profile compared favorably with that published for trabeculectomy and tube shunts. Conclusions The gelatin implant effectively reduced IOP and medication needs over 2 years in POAG uncontrolled medically, with an acceptable safety profile. ClinicalTrials.gov registration number: NCT02006693 (registered in the USA).
Deep sclerectomy with collagen implant is another surgical treatment option in the management of glaucoma, showing pressure results comparable with trabeculectomy but with a lower rate of early postoperative complications.
The authors report their initial clinical results with a novel wireless ocular telemetry sensor (OTS) (Sensimed AG, Switzerland) for continuous intraocular pressure (IOP) monitoring in patients with open angle glaucoma. This was a prospective, observational cohort of 15 patients. The OTS is a disposable silicone contact lens with an embedded micro-electromechanical system, which measures changes in corneal curvature induced by variations in IOP. An antenna, mounted around the eye, receives the data, which are then transmitted to a recorder. A signal was recorded in all patients. Thirteen (87%) patients completed 24-h IOP monitoring: one patient discontinued IOP monitoring due to device intolerance, and incomplete recordings were obtained in a second patient due to technical device malfunction. In 9/13 (69%) patients, the highest signals were recorded during the nocturnal period. No serious adverse events were recorded. The OTS shows good safety and functionality to monitor IOP fluctuations in patients over 24 h. This technology has the potential to provide hitherto unobtainable data on the chronobiology of IOP, possibly leading to improved care of glaucoma patients.
Deep sclerectomy with collagen implant appears to provide stable and reasonable control of IOP at long-term follow-up with few immediate postoperative complications.
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