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NCT07855770
Use of Preoperative Gas in Eyes With Macula-off Rhegmatogenous Retinal Detachment (RRD)
Conditions: Retinal Detachment Rhegmatogenous
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 190
Sponsor: Wills Eye
Location: Wilmer Eye Institute, Johns Hopkins Hospital Baltimore Maryland
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.
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Source: ClinicalTrials.gov (NCT07855770). StuddyBuddy aggregates publicly available trial information.