Methotrexate in Retinal Detachment With Proliferative Vitreoretinopathy

Benha University

Status: Completed

Conditions: Retinal Detachment

Treatments: Procedure: parsplana vitrectomy; Procedure: adjunctive use of Methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT07058337

Methorexate in PVR

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Group 1 (PPV Alone)

Active Comparator group

Description:

Patients in this group will undergo pars plana vitrectomy (PPV) only.

Treatment:

Procedure: parsplana vitrectomy

Group 2 (PPV with Methotrexate)

Active Comparator group

Description:

Patients in this group will receive complete PPV along with adjunctive intravitreal methotrexate

Treatment:

Procedure: adjunctive use of Methotrexate

Procedure: parsplana vitrectomy