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

NCT ID: NCT07038967

Last Updated: 2025-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-29

Study Completion Date

2025-12-01

Brief Summary

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

Detailed Description

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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%.

Conditions

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Non-Center Diabetic Macular Edema Phacoemulsification

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

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

Coloured photography

Intervention Type OTHER

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

Fluorescein angiography

Intervention Type OTHER

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

Optical coherence tomography

Intervention Type 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.

Interventions

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Coloured photography

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

Intervention Type OTHER

Fluorescein angiography

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

Intervention Type OTHER

Optical coherence tomography

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Hatem Fawzy Abd Elfatah Abo saif

Lecturer of Ophthalmology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Hatem F Abd Elfatah, MD

Role: CONTACT

00201001859927

Facility Contacts

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Hatem F Abd Elfatah, MD

Role: primary

00201001859927

Other Identifiers

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FMASU R127/2025

Identifier Type: -

Identifier Source: org_study_id

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