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.
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
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.
Parallel
Intravitreal 100% C3F8 Injection
Procedure/SurgeryPatients 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/SurgeryPatients with RRD will undergo standard of care treatment of RRD with pars plana vitrectomy or pars plana vitrectomy with scleral buckle
Visual Acuity
Best Corrected Visual Acuity
Anatomic Success Rate
Maintenance of retinal attachment and normal retinal structure. Assessed via clinical eye examination, Optical Coherence Tomography Imaging and Fundus autofluorescence.
Ellipsoid Zone disruption
Examination of presence, and extent of, ellipsoid zone disruption via Optical Coherence Tomography.
Retinal Displacement
Assessment of presence, and extent, of retinal displacement via clinical eye examination, Optical Coherence Tomography and Fundus autofluorescence
Metamorphopsia
Assessment of presence, and extent of, metamorphopsia via M-chart examination.
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Wills Eye
Lead sponsor
Johns Hopkins University
Collaborator
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