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IVI Aflibercept Before and After Phaco in DME.

Not Applicable
Completed
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
Inclusion Criteria
  • Diabetic patients with visually significant cataract
Exclusion Criteria
  • 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
NameTimeMethod
resolving of macular edemaSixth month

change in central macular thickness

Secondary Outcome Measures
NameTimeMethod
Improvement of visual acuitySixth month

measuring of BCVA

Trial Locations

Locations (1)

Ahady Hospital

🇰🇼

Al Qādisīyah, Hawally, Kuwait

Ahady Hospital
🇰🇼Al Qādisīyah, Hawally, Kuwait

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