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OpenTrials
Completed

NCT Number: NCT05731089

IVI Aflibercept Before and After Phaco in DME.

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).

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Key information

Conditions

Diabetic Macular Edema Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ahady Hospital

Al Qādisīyah, Hawally, 123, Kuwait

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phacoemulsification with IVI of aflibercept

Procedure

IVI was either before or after cataract surgery

Primary outcomes

  1. resolving of macular edema

    Time frame: Sixth month

    change in central macular thickness

Secondary outcomes

  1. Improvement of visual acuity

    Time frame: Sixth month

    measuring of BCVA

Sponsors and collaborators

Lead sponsor

Al Hadi Hospital

Other

Registry information

Official study title

Pre-Operative Versus Post-Operative Intravitreal Aflibercept Injection for Management of DME in Patients Undergoing Cataract Surgery

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 16, 2023
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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