An observational study in Rhegmatogenous Retinal Detachment and Retinal Detachment, sponsored by Clinica Oftalmologica Paredes. Completed at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Clinica Oftalmologica Paredes · Observational
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.
Rhegmatogenous retinal detachment (RRD) is a critical ophthalmic emergency caused by full-thickness retinal breaks that permit subretinal fluid accumulation, risking irreversible photoreceptor damage. Pneumatic retinopexy (PnR) combines intravitreal expansile gas injection with laser or cryotherapy retinopexy as a minimally invasive outpatient procedure. Although the landmark PIVOT trial demonstrated the non-inferiority and functional advantages of PnR compared to vitrectomy in selected cases, long-term 2-year prospective evidence on anatomical and functional outcomes in Latin American settings remains limited.
This prospective observational study evaluated 33 phakic adult patients presenting with superior RRD who strictly met adapted PIVOT eligibility criteria at Clínica Oftalmológica Paredes in Pasto, Colombia. Preoperative assessment included a comprehensive evaluation by a retina specialist, best-corrected visual acuity (BCVA), macular OCT (AngioVue/RTVue XR), and wide-field retinal photography (Eidon FA). Before gas injection, 577-nm yellow argon laser photocoagulation was applied to any retinal breaks without associated detachment.
The standardized surgical intervention was performed under topical anesthesia and operating room aseptic conditions, beginning with an anterior chamber paracentesis extracting 0.3 cc of aqueous humor, followed by an inferotemporal injection of 0.7 cc of 100% C3F8 gas 4 mm from the limbus and compressive hemostasis. Following the injection, patients maintained a strict face-down position for one hour and, after verifying foveal reattachment and intraocular pressure, initiated the steam-roll positioning maneuver to guide the gas bubble over the break.
Within 24 to 48 hours post-injection, once retinal reattachment was achieved, complete 577-nm yellow laser photocoagulation was performed around the breaks along with a 360° peripheral laser barrier, while non-responding cases were scheduled for secondary vitrectomy within one week. Long-term follow-up of successful cases was conducted on Day 1, at 3 weeks, 6 weeks, 3 months, and up to 24 months to document primary anatomical success, tear tamponade efficacy, BCVA evolution, IS/OS junction integrity on OCT, intraocular pressure dynamics, and complications such as macular edema or epiretinal membrane formation.
199 studies on the registry are indexed under Retinal Detachment; 29 are open to participants now.
This study's enrollment of 33 is below the median of 60 across 58 observational studies indexed under Retinal Detachment.
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Phakic adult patients presenting with primary superior rhegmatogenous retinal detachment (RRD) evaluated and treated at the retina service of Clínica Oftalmológica Paredes in Pasto, Colombia, who met adapted PIVOT trial eligibility criteria.
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Exclusion Criteria:
Phakic adult patients presenting with primary superior rhegmatogenous retinal detachment (RRD) meeting adapted PIVOT eligibility criteria. All participants underwent standardized pneumatic retinopexy, including anterior chamber paracentesis (0.3 cc), inferotemporal intravitreal 100% C3F8 gas injection (0.7 cc), initial face-down and steam-roll positioning, and postoperative 577-nm yellow argon laser retinopexy with a 360-degree peripheral barrier.
Procedure: Pneumatic Retinopexy
Standardized pneumatic retinopexy protocol including pre-gas 577-nm yellow argon laser to non-detached breaks (if applicable), anterior chamber paracentesis (0.3 cc), inferotemporal intravitreal injection of 100% C3F8 gas (0.7 cc), 1 hour of face-down positioning followed by steam-roll maneuver, and postoperative 577-nm yellow argon laser retinopexy with a 360-degree peripheral barrier once retinal reattachment is achieved.
Also known as: PnR, Pneumoretinopexia, C3F8 gas injection and laser retinopexy
Primary Anatomical Success Rate
Proportion of patients achieving sustained retinal reattachment following initial pneumatic retinopexy without requiring secondary surgical interventions (such as pars plana vitrectomy or scleral buckling).
Time frame: 24 months
Plan to share: No — Individual participant data will not be publicly shared in an open data repository. However, de-identified participant data and protocol details can be made available by the corresponding author upon reasonable academic request.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Clinica Oftalmologica Paredes