What this study is
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.
What's being tested
- Intravitreal 100% C3F8 Injection
Intervention · PROCEDURE
Patients with Macula off Rhegmatogenous Retinal Detachment will receive an intravitreal injection of 100% C3F8 prior to undergoing surgical repair for their condition
- Pars plana vitrectomy or pars plana vitrectomy with scleral buckle
Intervention · PROCEDURE
Patients with RRD will undergo standard of care treatment of RRD with pars plana vitrectomy or pars plana vitrectomy with scleral buckle
Study details
- Official title
- A Prospective, Randomized Study on the Use of Preoperative Gas in Eyes With Macula-off Rhegmatogenous Retinal Detachment (RRD)
- Sponsor
- Wills Eye
- Conditions
- Retinal Detachment Rhegmatogenous
- Enrolling
- 190 people
- Starts
- 2026-09-21
- Est. completion
- 2029-03
- Design
- Open-label, randomized, parallel groups, Phase 2, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- A patient must meet the following criteria to be eligible for inclusion in the study: 1. Diagnosed with macula-involving primary rhegmatogenous retinal detachment 2. Consents to surgical repair with pars plana vitrectomy with or without scleral buckling 3. Willing and able to comply with clinic visits and study-related procedures
You can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openWilmer Eye Institute, Johns Hopkins Hospital
Baltimore, Maryland, United States
- Zainab Rustam, MD · Contact6674147808zrustam2@jhmi.edu
Wills Eye Hospital
Philadelphia, Pennsylvania, United States
- Omar Masoud, MD · Contact4452133130omasoud@willseye.org
Study team
Sponsor
Wills Eye
Study ID IRB #2025-74
Principal investigator
Ajay Kuriyan, MD
Wills Eye Hospital
Principal investigator
Sidra Zafar, MD
The Johns Hopkins Wilmer Eye Institute
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.