Methotrexate Infusion and Intrasilicone Injection During Diabetic Vitrectomy

Anatomical and Functional Outcomes of Use of Methotrexate Infusion and Intrasilicone Injection During Diabetic Vitrectomy

The goal of this interventional clinical trial is to assess anatomical and functional outcomes of methotrexate use in irrigating fluid during parsplana vitrectomy combined with intrasilicone injection at end of surgery in patients with advanced proliferative diabetic retinopathy.

The main questions it aims to answer are:

1. Does methotrexate use in irrigating fluid during parsplana vitrectomy combined with intrasilicone injection at end of surgery decrease the post operative vitreoretinal proliferation after vitrectomy in patients with advanced proliferative diabetic retinopathy?
2. Does methotrexate use in irrigating fluid during parsplana vitrectomy combined with intrasilicone injection at end of surgery improve post operative functional outcome after vitrectomy in patients with advanced proliferative diabetic retinopathy?

Researchers will compare the anatomical and functional outcomes after vitrectomy in patients with advanced proliferative diabetic retinopathy without using methotrexate.

Tractional macular detachment (TMD) or macula threatening tractional retinal detachment (TRD) and combined tractional-rhegmatogenous retinal detachment (TRD/RRD) are considered as important indications for vitreoretinal intervention.

Although a growing number of eyes with TMD and TRD/RRD are successfully treated with a single procedure, retinal re-detachment associated with fibrovascular proliferation or proliferative vitreoretinopathy (PVR) is still a major cause of failure of the surgery.

Previous studies have shown increased expression of inflammatory cytokines and growth factors in both proliferative diabetic retinopathy (PDR) and PVR.

Methotrexate (MTX) is an anti-neoplastic and anti-inflammatory agent used to treat a variety of malignancies and rheumatologic diseases.

In ophthalmology, systemic and intraocular MTX has been successfully used for indeterminate uveitis, sarcoid uveitis and intraocular lymphoma.

MTX has been recently found to inhibit PVR by stopping cellular proliferation and promoting organized apoptosis. MTX has also been found to be effective in lowering the incidence of PVR when used as an adjunct in irrigation fluid during vitrectomy for retinal detachment.

Inclusion Criteria:

- Patients with diabetic tractional macular detachment or combined tractional- rhegmatogenous retinal detachment

Exclusion Criteria:

• Previous vitreoretinal surgery.
• Pregnant or lactating female.
• Co-existing pathology that might induce PVR such as penetrating ocular trauma or uveitis, co-existing congenital anomalies or hereditary vitreoretinopathies