Retinal Detachment
Conditions
Keywords
Proliferative Vitreoretinopathy, Rhegmatogenous Retinal Detachment, Methotrexate
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.
Interventions
PROCEDUREparsplana vitrectomy
23 gauge parsplana vitrectomy
PROCEDUREadjunctive use of Methotrexate
intravitreal methotrexate (200 μg/0.05 ml) at the time of surgery and repeated weekly for four weeks postoperatively
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Outcome results
None listed