Non-Center Involving Diabetic Macular Edema Progression in Early Postoperative Period After Phacoemulsification

Recruiting

• Conditions: Non-Center; Diabetic Macular Edema; Phacoemulsification

• Registration Number: NCT07038967
• Lead Sponsor: Ain Shams University

Brief Summary

This study aims to evaluate the progression of non-center-involving diabetic macular edema in the early postoperative period following phacoemulsification.

Detailed Description

Diabetic patients have been reported to have a higher prevalence of cataract and develop it at an earlier age compared with nondiabetic individuals.

According to recent population-based studies, diabetic macular edema (DME) is the most common cause of vision loss, with the incidence of non-center-involving DME (NCIDME) being higher than that of center-involving DME (CIDME). The prevalence of NCIDME in an urban south Indian population is 10.8%.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-18
• Study First Submitted QC: 2025-06-18
• Study First Posted: 2025-06-26
• Study Start: 2025-06-29
• Last Update Submitted: 2025-06-29
• Last Update Posted: 2025-07-01
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age ≥18 years.
• Both sexes.
• Patients with Grade I - Grade II nuclear cataract and non-center-involving diabetic macular edema (NCIDME).

Exclusion Criteria

• Traumatic cataract.
• Severe Non-Proliferative/ Proliferative Diabetic Retinopathy.
• Marked Asymmetry of retinopathy between both eyes.
• Mature senile cataract or severe lens opacity.
• Potentiality to have Phacotrabeculectomy surgery.
• Complications during or after the surgery.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity	6 months post-procedure	Best Corrected Visual Acuity (BCVA) will be recorded.

Secondary Outcome Measures

Name	Time	Method
Intra ocular pressure	6 months post-procedure	Intra ocular pressure (IOP) will be recorded.
Central macular thickness (CMT)	6 months post-procedure	Central macular thickness (CMT) will be recorded.
Frequency distribution of Fluorescein leakage	6 months post-procedure	Frequency distribution of Fluorescein leakage will be recorded.

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt