Proliferative Vitreoretinopathy Clinical Trial
Official title:
Comparison of Peroperative Methotrexate Infusion With Postoperative Intra Silicon Oil Methotrexate Injections for Prevention of Proliferative Vitreoretinopathy Development After Vitrectomy for Rhegmatogenous Retinal Detachment Repair.
This clinical trial, involving participants with rhegmatogenous retinal detachment, aims to compare Methotrexate Usage Techniques in preventing Proliferative Vitreoretinopathy (PVR) after vitrectomy. The study will evaluate the development of PVR, retinal detachment recurrence, and improvement in visual acuity. Participants will undergo retinal detachment surgery using the vitrectomy technique and will be divided into two groups. One group will receive Methotrexate infusion during surgery, while the other will receive repeated Methotrexate injections post-surgery. The researcher will analyze and compare outcomes between the two groups.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | May 2025 |
Est. primary completion date | February 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 70 Years |
Eligibility | Inclusion Criteria: - Rhegmatogenous Retinal Detachment Exclusion Criteria: - Presence of proliferative vitreoretinopathy grade C, previous retinal detachment surgery in the same eye, penetrating ocular trauma, Presence of intraocular foreign bodies, previous glaucoma filtration surgery, allergy to methotrexate, and pregnant and lactating women. |
Country | Name | City | State |
---|---|---|---|
Pakistan | Sahiwal Medical College & Teaching Hospital, Sahiwal, Pakistan | Sahiwal | Punjab |
Lead Sponsor | Collaborator |
---|---|
University of Health Sciences Lahore |
Pakistan,
El Baha S, Leila M, Amr A, Lolah MMA. Anatomical and Functional Outcomes of Vitrectomy with/without Intravitreal Methotrexate Infusion for Management of Proliferative Vitreoretinopathy Secondary to Rhegmatogenous Retinal Detachment. J Ophthalmol. 2021 Jul — View Citation
Jahangir S, Jahangir T, Ali MH, Lateef Q, Hamza U, Tayyab H. Use of Intravitreal Methotrexate Infusion in Complicated Retinal Detachment for Prevention of Proliferative Vitreoretinopathy in a Pilot Study. Cureus. 2021 Aug 25;13(8):e17439. doi: 10.7759/cur — View Citation
Nagpal M, Chaudhary P, Wachasundar S, Eltayib A, Raihan A. Management of recurrent rhegmatogenous retinal detachment. Indian J Ophthalmol. 2018 Dec;66(12):1763-1771. doi: 10.4103/ijo.IJO_1212_18. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Development of Proliferative Vitreoretinopathy (PVR) | Clinically evident PVR membrane formation | Within three months of Vitrectomy surgery | |
Primary | Recurrence of Retinal Detachment | Re detachment of retina after retinal detachment repair surgery by vitrectomy | Within three months of Vitrectomy surgery | |
Secondary | Visual Acuity Improvement | Improvement in visual acuity after retinal detachment repair by vitrectomy | Final visual acuity will be measured at completion of 3 month follow up or meeting the primary outcome, whichever is earlier. |
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