Chronic Edema of the Macula
Conditions
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).
Interventions
PROCEDUREvitrectomy with planned foveal detachment
23 gauge vitrectomy, posterior hyaloid detachment, internal limiting membrane peeling , sub-macular BSS injection using 38 gauge canula
Sponsors
Ministry of Health and Population, Egypt
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| central macular thickness decrease | 10 months postperative | decrease in central macular thickness by OCT |
Outcome results
None listed