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

NCT07038967 | Recruiting

• 1 other identifier: FMASU R127/2025
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-Center; Diabetic Macular Edema; Phacoemulsification

Outcome Measures

Primary Outcomes (1)

• Best Corrected Visual Acuity

  Best Corrected Visual Acuity (BCVA) will be recorded.

  6 months post-procedure

Secondary Outcomes (3)

• Intra ocular pressure

  6 months post-procedure

• Central macular thickness (CMT)

  6 months post-procedure

• Frequency distribution of Fluorescein leakage

  6 months post-procedure

Study Arms (1)

Study group

Patients with Grade I - Grade II nuclear cataract and non-center-involving diabetic macular edema (NCIDME)

Other: Coloured photography; Other: Fluorescein angiography; Other: Optical coherence tomography

Interventions

Coloured photography OTHER

Coloured photography will be performed preoperatively and at 3 and 6 months postoperatively.

Study group

Fluorescein angiography OTHER

Fluorescein angiography will be performed preoperatively and at 3 and 6 months postoperatively. The following features will be recorded on each angiography:

Study group

Optical coherence tomography OTHER

Optical coherence tomography (OCT) scanning will be performed using the optical coherence tomography scanner OCT (OPTOVUE OCT). OCT will be performed preoperatively and at 3 and 6 months postoperatively.

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This prospective study will be conducted on 50 diabetic patients aged ≥18 years, both sexes, with Grade I - Grade II nuclear cataract and non-center-involving diabetic macular edema (NCIDME).

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

RECRUITING

MeSH Terms

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Central Study Contacts

Hatem F Abd Elfatah, MD

CONTACT

00201001859927; tito78@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Ophthalmology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 26, 2025
• Study Start: June 29, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)