Repeated Methotrexate for Proliferative Vitreoretinopathy Grade C

  • STATUS
    Recruiting
  • End date
    Sep 1, 2021
  • participants needed
    74
  • sponsor
    Shahid Beheshti University of Medical Sciences
Updated on 24 January 2021

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 g 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.

Details
Condition Proliferative vitreoretinopathy
Treatment methotrexate
Clinical Study IdentifierNCT04482543
SponsorShahid Beheshti University of Medical Sciences
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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
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