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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Wills Eye
Study ID
NCT07855770
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • Retinal Detachment Rhegmatogenous

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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
  • 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

Study Details

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.

Key Dates

First listed
Oct 2, 2026
Start date
Sep 21, 2026
Status verified
Sep 2026
Primary completion
Sep 30, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
190 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Preoperative Gas
    Patients in this group will be injected with 0.3 cc of 100% C3F8 gas prior to surgical repair of the retinal detachment.
  • Active Comparator: Standard of Care
    Patients in this arm will receive standard of care treatment with Pars Plana Vitrectomy or Pars Plana vitrectomy with Scleral Buckle.

Primary Outcome Measure

Visual Acuity [ Time Frame: 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Wilmer Eye Institute, Johns Hopkins HospitalBaltimoreMaryland21287
Zainab Rustam, MD
6674147808
Wills Eye HospitalPhiladelphiaPennsylvania19107
Omar Masoud, MD
4452133130

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