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

NCT07794163 | Completed

• 1 other identifier: PT-CO40
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rhegmatogenous Retinal Detachment; Retinal Detachment

Keywords

Pneumatic Retinopexy; Retinal Tear; Laser Retinopexy; PIVOT Criteria; C3F8 Gas; Anatomic Outcomes; Visual Acuity

Outcome Measures

Primary Outcomes (1)

• 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).

  24 months

Study Arms (1)

Pneumatic Retinopexy (PnR) Cohort

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

Interventions

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.

Also known as: PnR, Pneumoretinopexia, C3F8 gas injection and laser retinopexy

Pneumatic Retinopexy (PnR) Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinica Oftalmologica Paredes: lead

Study Sites (1)

Clínica Oftalmológica Paredes

Pasto, Departamento de Nariño, 520002, Colombia

Location

Related Publications (11)

• Juncal VR, Bamakrid M, Jin S, Paracha Q, Ta Kim DT, Marafon SB, Francisconi CLM, Muni RH. Pneumatic Retinopexy in Patients with Primary Rhegmatogenous Retinal Detachment Meeting PIVOT Trial Criteria. Ophthalmol Retina. 2021 Mar;5(3):262-269. doi: 10.1016/j.oret.2020.07.022. Epub 2020 Jul 31.

  PMID: 32739607 RESULT

• Iannetta D, Valsecchi N, Finzi A, Mastropasqua R, Muni RH, Fontana L. Pneumatic retinopexy for primary rhegmatogenous retinal detachment: from a clinical trial to the real-life experience. BMC Ophthalmol. 2024 Jul 16;24(1):287. doi: 10.1186/s12886-024-03559-7.

  PMID: 39014314 RESULT

• Hillier RJ, Felfeli T, Berger AR, Wong DT, Altomare F, Dai D, Giavedoni LR, Kertes PJ, Kohly RP, Muni RH. The Pneumatic Retinopexy versus Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes Randomized Trial (PIVOT). Ophthalmology. 2019 Apr;126(4):531-539. doi: 10.1016/j.ophtha.2018.11.014. Epub 2018 Nov 22.

  PMID: 30468761 RESULT

• Muni RH, Felfeli T, Sadda SR, Juncal VR, Francisconi CLM, Nittala MG, Lindenberg S, Gunnemann F, Berger AR, Wong DT, Altomare F, Giavedoni LR, Kohly RP, Kertes PJ, Sarraf D, Hillier RJ. Postoperative Photoreceptor Integrity Following Pneumatic Retinopexy vs Pars Plana Vitrectomy for Retinal Detachment Repair: A Post Hoc Optical Coherence Tomography Analysis From the Pneumatic Retinopexy Versus Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes Randomized Trial. JAMA Ophthalmol. 2021 Jun 1;139(6):620-627. doi: 10.1001/jamaophthalmol.2021.0803.

  PMID: 33885738 RESULT

• Chizzolini M, Martini F, Melis R, Montericcio A, Raimondi R, Allegrini D, Romano MR. Pneumatic retinopexy versus scleral buckling for the management of primary rhegmatogenous retinal detachment. Eur J Ophthalmol. 2023 Jan;33(1):498-505. doi: 10.1177/11206721221095041. Epub 2022 Apr 25.

  PMID: 35469453 RESULT

• Roshanshad A, Shirzadi S, Binder S, Arevalo JF. Pneumatic Retinopexy Versus Pars Plana Vitrectomy for the Management of Retinal Detachment: A Systematic Review and Meta-Analysis. Ophthalmol Ther. 2023 Apr;12(2):705-719. doi: 10.1007/s40123-023-00653-9. Epub 2023 Jan 30.

  PMID: 36717526 RESULT

• Shah S, Chou B, Patel M, Watane A, Shah L, Yannuzzi N, Sridhar J. Review and analysis of history and utilization of pneumatic retinopexy after pneumatic retinopexy versus vitrectomy for the management of primary rhegmatogenous retinal detachment outcomes randomized trial (PIVOT). Curr Opin Ophthalmol. 2024 May 1;35(3):217-222. doi: 10.1097/ICU.0000000000001039. Epub 2024 Feb 15.

  PMID: 38364771 RESULT

• Fernandez-Vega Gonzalez A, Muni RH. The history of pneumatic retinopexy: have we come full circle? Acta Ophthalmol. 2022 Feb;100(1):118-120. doi: 10.1111/aos.14876. Epub 2021 Apr 14.

  PMID: 33855814 RESULT

• Ge JY, Teo ZL, Chee ML, Tham YC, Rim TH, Cheng CY, Wong TY; SNEC Surgical Retina Research Group; Wong EYM, Lee SY, Cheung N. International incidence and temporal trends for rhegmatogenous retinal detachment: A systematic review and meta-analysis. Surv Ophthalmol. 2024 May-Jun;69(3):330-336. doi: 10.1016/j.survophthal.2023.11.005. Epub 2023 Nov 23.

  PMID: 38000699 RESULT

• Kuhn F, Aylward B. Rhegmatogenous retinal detachment: a reappraisal of its pathophysiology and treatment. Ophthalmic Res. 2014;51(1):15-31. doi: 10.1159/000355077. Epub 2013 Oct 22.

  PMID: 24158005 RESULT

• Ellakwa AF. Long term results of pneumatic retinopexy. Clin Ophthalmol. 2012;6:55-9. doi: 10.2147/OPTH.S22063. Epub 2012 Jan 9.

  PMID: 22275808 RESULT

MeSH Terms

Conditions

Retinal Detachment; Retinal Perforations

Interventions

perflutren

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Scientific Director

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: June 6, 2020
• Primary Completion: November 11, 2023
• Study Completion: April 7, 2026
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)