protocolSection identificationModule nctId: NCT06289205, orgStudyIdInfo id: 60/IRB/SLMC/SWL, briefTitle: "Comparing Methotrexate Usage Techniques to Prevent Proliferative Vitreoretinopaty After Retinal Detachment Vitrectomy", statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: University of Health Sciences Lahore, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Proliferative Vitreoretinopathy, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Using lottery methods patients will be divided into two groups with 60 subjects in each group. Group 1 will be regarded as control group and per operative methotrexate infusion will be used by mixing 75 mg of methotrexate into one litre of BSS solution. Group 2 will be regarded as the study group and will receive 500 µg of intra-silicon oil methotrexate at the end of the surgery and then at 1st, 2nd, 3rd, 4th and 6th post operative weeks., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: This will be a single-blind study in which the subjects will be unaware of the intervention. Blinding will be maintained by ensuring that subjects are unaware of the dosing regimens they are receiving., whoMasked: PARTICIPANT, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Methotrexate, outcomesModule primaryOutcomes measure: Development of Proliferative Vitreoretinopathy (PVR), primaryOutcomes measure: Recurrence of Retinal Detachment, secondaryOutcomes measure: Visual Acuity Improvement, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sahiwal Medical College & Teaching Hospital, Sahiwal, Pakistan, status: RECRUITING, city: Sahiwal, state: Punjab, zip: 57000, country: Pakistan, contacts name: Ahmad Z Jamil, FCPS,FRCS, role: CONTACT, phone: +923334853851, email: ahmadzeeshandr@gmail.com, geoPoint lat: 30.66667, lon: 73.1, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-02-24, uploadDate: 2024-02-24T14:05, filename: Prot_SAP_000.pdf, size: 182492, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-02-24, uploadDate: 2024-02-24T14:06, filename: ICF_001.pdf, size: 185782, hasResults: False