IVI Aflibercept Before and After Phaco in DME.

Al Hadi Hospital40 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Macular Edema

Interventions

Phacoemulsification with IVI of afliberceptPROCEDURE

IVI was either before or after cataract surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Ahady Hospital

Al Qādisīyah, Hawally, Kuwait

Outcomes

Primary Outcomes

resolving of macular edema

change in central macular thickness

Time frame: Sixth month

Secondary Outcomes

Improvement of visual acuity

measuring of BCVA

Time frame: Sixth month

Data from ClinicalTrials.gov

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