Methotrexate as an Adjunct to Parsplana Vitrectomy for the Preventing and Treatment of Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment: A Clinical Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Benha University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Visual Acuity
Study Overview
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:
- 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Group 1 (PPV Alone)
Patients in this group will undergo pars plana vitrectomy (PPV) only.
Intervention: parsplana vitrectomy (Procedure)
Group 2 (PPV with Methotrexate)
Patients in this group will receive complete PPV along with adjunctive intravitreal methotrexate
Intervention: parsplana vitrectomy (Procedure)
Group 2 (PPV with Methotrexate)
Patients in this group will receive complete PPV along with adjunctive intravitreal methotrexate
Intervention: adjunctive use of Methotrexate (Procedure)
Outcomes
Primary Outcomes
Visual Acuity
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
No secondary outcomes reported
Investigators
Ehab Mohamed Elsayed Mohamed Saad
Lecturer
Benha University