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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (PPV Alone) | Active Comparator | Patients in this group will undergo pars plana vitrectomy (PPV) only. |
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| Group 2 (PPV with Methotrexate) | Active Comparator | Patients in this group will receive complete PPV along with adjunctive intravitreal methotrexate |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| parsplana vitrectomy | Procedure | 23 gauge parsplana vitrectomy |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | within 6 months after tamponade removal |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ebsar Eye Center | Cairo | Egypt | 4450113 | Egypt |
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| ID | Term |
|---|---|
| D012163 | Retinal Detachment |
| D018630 | Vitreoretinopathy, Proliferative |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| adjunctive use of Methotrexate | Procedure | intravitreal methotrexate (200 μg/0.05 ml) at the time of surgery and repeated weekly for four weeks postoperatively |
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