Comparing methods of using Methotrexate to prevent eye complications after retinal surgery
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.
PHASE1; PHASE2 · University of Health Sciences Lahore · NCT06289205
This study is testing whether giving Methotrexate during eye surgery or through injections afterward can help prevent complications and improve vision for people having surgery for retinal detachment.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | University of Health Sciences Lahore (other) |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Sahiwal, Punjab) |
| Trial ID | NCT06289205 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare different techniques of administering Methotrexate to prevent Proliferative Vitreoretinopathy (PVR) in patients undergoing vitrectomy for rhegmatogenous retinal detachment. Participants will be randomly assigned to receive either Methotrexate infusion during surgery or repeated injections post-surgery. The study will evaluate the incidence of PVR, recurrence of retinal detachment, and improvements in visual acuity over a follow-up period. Conducted at two hospitals in Pakistan, the trial will adhere to ethical guidelines and obtain informed consent from all participants.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 20 to 70 with rhegmatogenous retinal detachment.
Not a fit: Patients with grade C proliferative vitreoretinopathy or those who have had previous retinal surgery in the same eye will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of PVR and improve visual outcomes for patients undergoing retinal detachment surgery.
How similar studies have performed: While similar approaches have been explored, this specific comparison of Methotrexate usage techniques in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Sahiwal, Punjab
- Sahiwal Medical College & Teaching Hospital, Sahiwal, Pakistan — Sahiwal, Punjab, Pakistan (RECRUITING)
Study contacts
- Principal investigator: Ahmad Z Jamil, FCPS,FRCS — Sahiwal Medical College, Sahiwal, Pakistan
- Study coordinator: Ahmad Z Jamil, FCPS,FRCS
- Email: ahmadzeeshandr@gmail.com
- Phone: +923334853851
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Proliferative Vitreoretinopathy, Methotrexate, Retinal detachment, Vitrectomy