Methotrexate in Retinal Detachment With Proliferative Vitreoretinopathy

Benha University20 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Retinal Detachment

Interventions

parsplana vitrectomyPROCEDURE

23 gauge parsplana vitrectomy

adjunctive use of MethotrexatePROCEDURE

intravitreal methotrexate (200 μg/0.05 ml) at the time of surgery and repeated weekly for four weeks postoperatively

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged 18 years and older. * Diagnosed with RRD with clinical signs of PVR. * No history of prior ocular surgeries for RRD or PVR. Exclusion Criteria: * Patients with other retinal diseases (e.g., diabetic retinopathy or retinal vascular occlusions). * Individuals with significant systemic illnesses that could influence surgical outcomes.

Locations (1)

Ebsar Eye Center

Cairo, Egypt, Egypt

Outcomes

Primary Outcomes

Visual Acuity

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.

Time frame: 3 and 6 months after tamponade removal

Anatomical Success

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.

Time frame: within 6 months after tamponade removal

Number of Operations Required

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.

Time frame: within 6 months after tamponade removal

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.