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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intra-silicone oil injection of 250 µg methotrexate | Active Comparator |
| |
| No intra-silicone oil injection of methotrexate | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate | Drug | Intra-silicone oil injection of 250 µg methotrexate is done at the end of surgery and is repeated at weeks 3 and 6 postoperatively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Retinal reattachment rate | Funduscopy | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected visual acuity | Snellen chart | 6 months |
| Retinal reproliferation rate | Funduscopy | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hamid Ahmadieh, MD | Contact | +98 9122195871 | hahmadieh@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmic Research Center | Recruiting | Tehran | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39572739 | Derived | Nourinia R, Safi S, Mohammadpour M, Riazi-Esfahani H, Ansari Astaneh MR, Falavarjani KG, Ramezani A, Karimi S, Fekri S, Ebrahimiadib N, Khalili Pour E, Nikkhah H, Shoeibi N, Hassanpoor N, Hosseini M, Abrishami M, Abdi F, Rahimi A, Jabbarpoor Bonyadi MH, Moradian S, Khosravi Mirzaei S, Safi H, Anvari P, Fadakar K, Mirghorbani M, Mohammadbagheri N, Hatami F, Kheiri B, Yaseri M, Khorrami Z, Ahmadieh H. Effects of repeated intra-silicone oil injections of methotrexate on proliferative vitreoretinopathy grade C: a multicenter randomized controlled trial. Sci Rep. 2024 Nov 21;14(1):28842. doi: 10.1038/s41598-024-79708-1. |
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| ID | Term |
|---|---|
| D018630 | Vitreoretinopathy, Proliferative |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Adverse events | Slit-lamp, tonometry and funduscopy | 6 months |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |