Proliferative Vitreoretinopathy
Conditions
Brief summary
This multicenter randomized clinical trial evaluates the effect of multiple intra-silicone oil injections of methotrexate (MTX) on rhegmatogenous retinal detachment (RRD) with grade C proliferative vitreoretinopathy (PVR). 74 eyes with the diagnosis of RRD with PVR grade C will be randomized into two groups: the intervention group and the control group. All eyes undergo pars plana vitrectomy(PPV) and intraocular injection of silicone oil (SO). At the end of the surgical procedure, intra-SO injection of 250 µg MTX will be performed in the intervention group. No intra-SO injection will be done in the control group. In the intervention group, Intra-SO injection of MTX will be repeated at 3 and 6 weeks postoperatively. Silicone oil removal will be done 3 months after surgery.Spectral-domain optical coherence tomography (SD-OCT) image of the macula will be acquired at months 3 and 6. The retinal reattachment rate at months 6 will be assessed as the main outcome measure of the study. Best corrected visual acuity, retinal reproliferation rate and adverse events are the secondary outcome measures. Comprehensive ocular examination will be performed at weeks 1, 3, 6 and at months 3, 4 and 6.
Interventions
DRUGMethotrexate
Intra-silicone oil injection of 250 µg methotrexate is done at the end of surgery and is repeated at weeks 3 and 6 postoperatively.
Sponsors
Shahid Beheshti University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Rhegmatogenous retinal detachment with proliferative vitreoretinopathy grade C
Exclusion criteria
* Age of under 18 years old * Pregnancy * Glaucoma * Macular disorders * Diabetic retinopathy * Retinal vascular occlusion * History of penetrating ocular trauma * Giant retinal tear * Chronic uveitis * History of intraocular steroid injection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retinal reattachment rate | 6 months | Funduscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best corrected visual acuity | 6 months | Snellen chart |
| Retinal reproliferation rate | 6 months | Funduscopy |
| Adverse events | 6 months | Slit-lamp, tonometry and funduscopy |
Countries
Iran
Contacts
Primary ContactHamid Ahmadieh, MD
Outcome results
None listed