Diabetic Retinopathy, Vitreomacular Traction
Conditions
Keywords
Methotrexate, proliferative diabetic retinopathy
Brief summary
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.
Detailed description
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.
Interventions
DRUGMethotrexate 25 MG/ML
Methotrexate is a folate derivative that inhibits several enzymes responsible for nucleotide synthesis. This inhibition leads to suppression of inflammation as well as prevention of cell division.
PROCEDUREparsplana vitrectomy
Pars plana vitrectomy (PPV) is a technique in vitreoretinal surgery that enables access to the posterior segment for treating tractional retinal detachment in advanced proliferative diabetic retinopathy, in a controlled, closed system.
Sponsors
Minia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| assess retinal layers by optical coherence tomography | one month after pars plana vitrectomy and one month after silicone oil evacuation | presence of epiretinal membrane, cystic changes in retina, central macular thickens |
| assess functional outcomes by multifocal electroretinogram | one month after pars plana vitrectomy and one month after silicone oil evacuation | latency and amplitude of main P wave |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| visual acuity | one month after pars plana vitrectomy and one month after silicone oil evacuation | by logMAR (Logarithm of the Minimum Angle of Resolution) |
| Anterior segment slit lamp biomicroscopic examination | one month after pars plana vitrectomy | assess anterior segment inflammation as iritis or posterior synechia |
Countries
Egypt
Outcome results
None listed