Use of Preoperative Gas in Eyes With Macula-off Rhegmatogenous Retinal Detachment (RRD)

NCT07855770 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: IRB #2025-74
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate whether a preoperative intraocular gas injection improves visual outcomes in patients with a macula-off rhegmatogenous retinal detachment (RRD). While current surgical therapies successfully reattach the retina, visual recovery can vary. This study will investigate if injecting a small amount of gas (0.3 cc of 100% C3F8) into the eye prior to standard surgery can decrease the duration of macular detachment, reduce retinal displacement, and ultimately result in better final visual acuity compared to the standard of care alone.

Conditions

Retinal Detachment Rhegmatogenous

Keywords

Retinal Detachment; Rhegmatogenous Retinal Detachment; Scleral Buckle; Pars Plana Vitrectomy; C3F8 Gas

Outcome Measures

Primary Outcomes (1)

• Visual Acuity

  Best Corrected Visual Acuity

  6 months

Secondary Outcomes (4)

• Anatomic Success Rate

  6 months

• Ellipsoid Zone disruption

  6 months

• Retinal Displacement

  6 months

• Metamorphopsia

  6 months

Study Arms (2)

Preoperative Gas

EXPERIMENTAL

Patients in this group will be injected with 0.3 cc of 100% C3F8 gas prior to surgical repair of the retinal detachment.

Procedure: Intravitreal 100% C3F8 Injection; Procedure: Pars plana vitrectomy or pars plana vitrectomy with scleral buckle

Standard of Care

ACTIVE COMPARATOR

Patients in this arm will receive standard of care treatment with Pars Plana Vitrectomy or Pars Plana vitrectomy with Scleral Buckle.

Procedure: Pars plana vitrectomy or pars plana vitrectomy with scleral buckle

Interventions

Pars plana vitrectomy or pars plana vitrectomy with scleral buckle PROCEDURE

Patients with RRD will undergo standard of care treatment of RRD with pars plana vitrectomy or pars plana vitrectomy with scleral buckle

Preoperative Gas; Standard of Care

Intravitreal 100% C3F8 Injection PROCEDURE

Patients with Macula off Rhegmatogenous Retinal Detachment will receive an intravitreal injection of 100% C3F8 prior to undergoing surgical repair for their condition

Preoperative Gas

Eligibility Criteria

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

You may not qualify if:

• A patient who meets any of the following criteria will be excluded from the study: 1. Age \< 18 years old 2. Presence of PVR grade C or worse (as defined by the revised Retina Society PVR classification) at time of surgical repair 3. History of or concurrent ruptured globe, intraocular foreign body, proliferative diabetic retinopathy, retinal vein occlusion, exudative age-related macular degeneration, macular epiretinal membrane, sickle cell disease, uveitis or intraocular infectious diseases 4. Not willing or able to comply with clinic visits and study-related procedures 5. Unable to provide a signed informed consent 6. Unable to maintain positioning to support break 7. Patients that undergo silicone oil placement for primary macula-off RRD 8. For bilateral macula-off RRDs, the better seeing eye will be excluded.

Sponsors & Collaborators

• Wills Eye: lead
• Johns Hopkins University: collaborator

Study Sites (2)

Wilmer Eye Institute, Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (4)

• Hwang JC. Regional practice patterns for retinal detachment repair in the United States. Am J Ophthalmol. 2012 Jun;153(6):1125-8. doi: 10.1016/j.ajo.2011.11.034. Epub 2012 Feb 8.

  PMID: 22321800 BACKGROUND

• 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 BACKGROUND

• Brosh K, Francisconi CLM, Qian J, Sabatino F, Juncal VR, Hillier RJ, Chaudhary V, Berger AR, Giavedoni LR, Wong DT, Altomare F, Kadhim MR, Newsom RB, Marafon SB, Muni RH. Retinal Displacement Following Pneumatic Retinopexy vs Pars Plana Vitrectomy for Rhegmatogenous Retinal Detachment. JAMA Ophthalmol. 2020 Jun 1;138(6):652-659. doi: 10.1001/jamaophthalmol.2020.1046.

  PMID: 32324204 BACKGROUND

• Felfeli T, Mandelcorn MS, Trussart R, Mandelcorn ED. PREOPERATIVE GAS FOR PARS PLANA VITRECTOMY: A SURGICAL TECHNIQUE FOR REPAIR OF RHEGMATOGENOUS RETINAL DETACHMENTS WITH MULTIPLE, LARGE, OR INFERIOR BREAKS. Retin Cases Brief Rep. 2023 Jul 1;17(4):374-379. doi: 10.1097/ICB.0000000000001197. Epub 2021 Sep 27.

  PMID: 34652305 BACKGROUND

MeSH Terms

Conditions

Retinal Detachment

Interventions

Scleral Buckling

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Ajay Kuriyan, MD

  Wills Eye Hospital

  PRINCIPAL INVESTIGATOR

• Sidra Zafar, MD

  The Johns Hopkins Wilmer Eye Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Omar Masoud, MD

CONTACT

4452133130; omasoud@willseye.org

Zainab Rustam, MD

CONTACT

6674147808; zrustam2@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start: September 21, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)