Methotrexate in Retinal Detachment With Proliferative Vitreoretinopathy
- Conditions
- Retinal Detachment
- Registration Number
- NCT07058337
- Lead Sponsor
- Benha University
- Brief Summary
The aim of this study is to evaluate the efficacy and safety of intraocular methotrexate (MTX) in preventing and managing proliferative vitreoretinopathy (PVR) in patients undergoing retinal detachment surgery
- Detailed Description
Patients will be randomized into two groups if clinical evidence of PVR is detected at the time of surgery, utilizing a computer-generated list for randomization. All surgeries will be conducted by the same surgeon to maintain consistency in technique.
Intervention Groups:
1. Group 1 (PPV Alone): Patients in this group will undergo pars plana vitrectomy (PPV) only.
Group 2 (PPV with Methotrexate): Patients in this group will receive complete PPV along with adjunctive intravitreal methotrexate.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Patients aged 18 years and older.
- Diagnosed with RRD with clinical signs of PVR.
- No history of prior ocular surgeries for RRD or PVR.
- Patients with other retinal diseases (e.g., diabetic retinopathy or retinal vascular occlusions).
- Individuals with significant systemic illnesses that could influence surgical outcomes.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Visual Acuity 3 and 6 months after tamponade removal Best-Corrected Visual Acuity (BCVA):
BCVA will be measured using the logarithm of the minimum angle of resolution (LogMAR) scale. A LogMAR value of 0.0 corresponds to normal visual acuity (Snellen equivalent 6/6 or 20/20), representing the ability to resolve an optotype that subtends 5 minutes of arc. Visual acuity will be converted to LogMAR values for statistical analysis.Anatomical Success within 6 months after tamponade removal Successful Retinal Reattachment:
Defined as complete reattachment of the neurosensory retina to the underlying retinal pigment epithelium (RPE) without persistent or recurrent subretinal fluid at the final follow-up visit, as confirmed by clinical examination and optical coherence tomography (OCT), in the absence of tamponade or additional surgical intervention.Number of Operations Required within 6 months after tamponade removal The total number of surgical procedures (including vitrectomy, scleral buckling, retinopexy, or tamponade exchange) required to achieve and maintain retinal reattachment will be recorded for each eye.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ebsar Eye Center
🇪🇬Cairo, Egypt
Ebsar Eye Center🇪🇬Cairo, Egypt