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Completed NCT07794163

Anatomical and Functional Outcomes of Pneumatic Retinopexy for Retinal Detachment: A 2-Year Case Series

Conditions: Rhegmatogenous Retinal Detachment, Retinal Detachment

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 33
Sponsor: Clinica Oftalmologica Paredes

Location: Clínica Oftalmológica Paredes Pasto Departamento de Nariño

Summary

The goal of this observational study is to evaluate the 2-year anatomical and functional outcomes of pneumatic retinopexy in phakic adult patients with superior rhegmatogenous retinal detachment meeting adapted PIVOT eligibility criteria. The main questions it aims to answer are to determine the primary anatomical success rate over 24 months-defined as sustained retinal reattachment without secondary vitrectomy or scleral buckling-and to evaluate long-term visual acuity outcomes and structural macular integrity measured by OCT. As a single-arm observational case series, participants undergo baseline ophthalmic evaluation (BCVA, OCT, and fundus photography), followed by a standardized outpatient procedure consisting of anterior chamber paracentesis (0.3 cc), inferotemporal intravitreal 100% C3F8 gas injection (0.7 cc), face-down positioning followed by the steam-roll maneuver, postoperative 577-nm yellow laser retinopexy with a 360° peripheral barrier upon reattachment, and protocolized follow-up evaluations on Day 1, at 3 weeks, 6 weeks, 3 months, and up to 24 months.

Eligibility Criteria

Inclusion Criteria: * Age 18 years or older. * Phakic status in the study eye. * Diagnosis of primary rhegmatogenous retinal detachment (RRD). * Single retinal break or a group of breaks extending within 1 clock hour of the upper retina (located between 8:00 and 4:00 clock hours). * Ability and willingness to comply with post-procedure face-down positioning, steam-roll maneuvers, and scheduled follow-up visits. Exclusion Criteria: * Pseudophakic or aphakic status. * Retinal breaks located in the inferior 4 clock hours (between 4:00 and 8:00 clock hours). * Multiple retinal breaks spanning more than 1 clock hour. * Presence of proliferative vitreoretinopathy (PVR) grade C or D. * Media opacities obstructing adequate visualization of the fundus or preventing effective laser photocoagulation (e.g., severe vitreous hemorrhage or advanced cataract). * Uncontrolled baseline intraocular pressure or pre-existing advanced glaucoma. * History of prior vitreoretinal surgery in the study eye. * Physical, mental, or geographic inability to maintain strict post-procedure positioning or fulfill protocol requirements.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07794163). StuddyBuddy aggregates publicly available trial information.