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Randomized Controlled Trial
. 2024 Nov 21;14(1):28842.
doi: 10.1038/s41598-024-79708-1.

Effects of repeated intra-silicone oil injections of methotrexate on proliferative vitreoretinopathy grade C: a multicenter randomized controlled trial

Ramin Nourinia #  1 , Sare Safi #  2 , Mehrad Mohammadpour  1 , Hamid Riazi-Esfahani  3 , Mohammad Reza Ansari Astaneh  4 , Khalil Ghasemi Falavarjani  5 , Alireza Ramezani  2   6   7 , Saeed Karimi  1   6   7   8 , Sahba Fekri  1   8 , Nazanin Ebrahimiadib  3 , Elias Khalili Pour  3 , Homayoun Nikkhah  1   6   7 , Nasser Shoeibi  4 , Narges Hassanpoor  9 , Maryam Hosseini  4 , Mojtaba Abrishami  4 , Fatemeh Abdi  5 , Anoushiravan Rahimi  10 , Mohammad Hossein Jabbarpoor Bonyadi  11 , Siamak Moradian  2   8 , Sina Khosravi Mirzaei  1   12 , Hamid Safi  1   6 , Pasha Anvari  5 , Kaveh Fadakar  3 , Masoud Mirghorbani  3 , Niloufar Mohammadbagheri  1 , Firouze Hatami  1   12 , Bahareh Kheiri  1   2 , Mehdi Yaseri  13 , Zahra Khorrami  2 , Hamid Ahmadieh  14
Affiliations
Randomized Controlled Trial

Effects of repeated intra-silicone oil injections of methotrexate on proliferative vitreoretinopathy grade C: a multicenter randomized controlled trial

Ramin Nourinia et al. Sci Rep. .

Abstract

In this randomized controlled trial, we assessed the effects of three consecutive intra-silicone oil (SO) injections of methotrexate (MTX) on the outcomes of surgery for proliferative vitreoretinopathy grade C (PVR-C). Seventy-four eyes of 74 patients with PVR-C were included. Of these, 37 eyes were assigned to the MTX group and 37 eyes to the control group. Fourteen patients failed to comply with the 6-month follow-up period. All eyes underwent vitrectomy and SO injection. In the MTX group, 250 µg MTX was injected into the SO after surgery and at weeks 3 and 6 postoperatively. The primary outcome was the retinal reattachment rate at 6 months. The secondary outcomes included limited PVR recurrence and adverse events. Retinal reattachment was achieved in 22 eyes (73.3%) in the MTX group and 23 eyes (76.7%) in the control group (difference: -3.4%, 95% CI: -25.2-18.5%). Limited PVR recurrence was observed in one eye (4.5%) in the MTX group versus nine eyes (39.1%) in the control group at 6 months (P = 0.01). No adverse effects were observed. Adjunctive treatment with three consecutive applications of intra-SO MTX did not reveal a significant effect on the retinal re-detachment rate but could statistically significantly reduce limited PVR recurrence.Trial registration: http//ClinicalTrials.gov NCT04482543, 22/07/2020.

Keywords: Methotrexate; Proliferative vitreoretinopathy; Randomized controlled trial.

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Conflict of interest statement

Declarations. Competing interests: The authors declare no competing interests. Ethical approval: Ethical approval was obtained (IR.SBMU.ORC.REC.1399.007) from the Ethics Committee of the Ophthalmic Research Center at the Research Institute for Ophthalmology and Vision Science, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Informed consent was obtained from all participants.

Figures

Fig. 1
Fig. 1
CONSORT 2010 flow diagram of the study.
Fig. 2
Fig. 2
Kaplan-Meier graph for survival in MTX and control groups.
See this image and copyright information in PMC

References

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