IVI Aflibercept Before and After Phaco in DME.
- Conditions
- Diabetic Macular Edema
- Registration Number
- NCT05731089
- Lead Sponsor
- Al Hadi Hospital
- Brief Summary
To study whether or not cataract surgery should be deferred until treating the co-existing diabetic macular edema (DME) using intravitreal (IVI) anti-vascular endothelial growth factor (anti-VEGF).
- Detailed Description
A prospective randomized interventional study included diabetic patients with visually significant cataract and DME. Patients were divided into 2 groups. Group A received three pre-operative intravitreal Aflibercept injections with a monthly interval, the third injection was given intra-operatively. Group B received a single intra-operative injection, and two post-operative injections with a monthly interval. follow up for 6 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Diabetic patients with visually significant cataract
- previous vitreoretinal surgery
- laser or intravitreal injections 6 months prior to the procedure
- intractable glaucom
- active intra-ocular inflammation
- retinal detachment
- vitreous hemorrhage
- epi-retinal membranes
- any other retinal vascular or neuroretinal disease.
- Patients with eventual cataract surgeries
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method resolving of macular edema Sixth month change in central macular thickness
- Secondary Outcome Measures
Name Time Method Improvement of visual acuity Sixth month measuring of BCVA
Related Research Topics
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Trial Locations
- Locations (1)
Ahady Hospital
🇰🇼Al Qādisīyah, Hawally, Kuwait
Ahady Hospital🇰🇼Al Qādisīyah, Hawally, Kuwait