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

A

Ain Shams University

Status

Enrolling

Conditions

Diabetic Macular Edema
Phacoemulsification
Non-Center

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT07038967
FMASU R127/2025

Details and patient eligibility

About

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

Full 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%.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Study group
Description:
Patients with Grade I - Grade II nuclear cataract and non-center-involving diabetic macular edema (NCIDME)
Treatment:
Other: Optical coherence tomography
Other: Coloured photography
Other: Fluorescein angiography

Trial contacts and locations

1

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Central trial contact

Hatem F Abd Elfatah, MD

Data sourced from clinicaltrials.gov

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