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Completed

NCT Number: NCT07794163

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clínica Oftalmológica Paredes

Pasto, Departamento de Nariño, 520002, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pneumatic Retinopexy

Procedure

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.

Other names: PnR, Pneumoretinopexia, C3F8 gas injection and laser retinopexy

Primary outcomes

  1. Primary Anatomical Success Rate

    Time frame: 24 months

    Proportion of patients achieving sustained retinal reattachment following initial pneumatic retinopexy without requiring secondary surgical interventions (such as pars plana vitrectomy or scleral buckling).

Sponsors and collaborators

Lead sponsor

Clinica Oftalmologica Paredes

Other

Registry information

Official study title

Anatomical and Functional Outcomes of Pneumatic Retinopexy for Rhegmatogenous Retinal Detachment Using PIVOT Criteria: A 2-Year Case Series From a Referral Center in Southwestern Colombia

Important dates

Study start
2020
Primary completion
2023
Study completion
2026
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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