Vitrectomy With Planned Foveal Detachment for Refractory DME With or Without Vitreo-macular Interface Abnormality
Not Applicable
- Conditions
- Chronic Edema of the Macula
- Interventions
- Procedure: vitrectomy with planned foveal detachment
- Registration Number
- NCT03345056
- Lead Sponsor
- Ministry of Health and Population, Egypt
- Brief Summary
To evaluate the therapeutic efficacy of sub retinal BSS injections in conjunction with conventional vitrectomy for refractory Diabetic macular edema (DME)- resistant to more than one anti-VEGF agent, intravitreal corticosteroids and to previous vitrectomy. Some of enrolled cases had normal vitreo-macular interface (VMI) relationship, while other cases had incomplete vitreoretinal separation with vitreomacular attachment (VMA).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
- Cases with refractory DME with a central macular thickness (CMT) of more than 300 µm despite undergoing anti-VEGF therapy (5-6 monthly injections of ranibizumab (IVR) or bevacizumab (IVB) with shifting to aflibercept (IVA) for additional 3 injections).
Exclusion Criteria
- The major exclusion criteria were: (1) presence of apparent retinal pigment epithelium (RPE) atrophy at or near the macula; (2) presence of proliferative diabetic fibrovascular membranes threating or at the macula; (3) presence of diabetic optic atrophy; and (4) presence of neovascular glaucoma.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description included cases vitrectomy with planned foveal detachment vitrectomy done with planned foveal separation and followed for the result
- Primary Outcome Measures
Name Time Method central macular thickness decrease 10 months postperative decrease in central macular thickness by OCT
- Secondary Outcome Measures
Name Time Method