Proliferative Vitreoretinopathy Clinical Trial
Official title:
Repeated Intra-silicone Oil Injection of Methotrexate for Management of Proliferative Vitreoretinopathy Grade C; A Multi-center Study
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.
n/a
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