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NCT Number: NCT07038967

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

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

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Key information

Conditions

Non-Center Diabetic Macular Edema Phacoemulsification

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ain Shams University

Cairo, 11591, Egypt

Location status: Recruiting

Location contact

Hatem F Abd Elfatah, MD

CONTACT

[email protected]

00201001859927

Samah M Fawzy, MD

PRINCIPAL_INVESTIGATOR

Tarek M Saad, MD

PRINCIPAL_INVESTIGATOR

About this study

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%.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Coloured photography

Other

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

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:

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.

Primary outcomes

  1. Best Corrected Visual Acuity

    Time frame: 6 months post-procedure

    Best Corrected Visual Acuity (BCVA) will be recorded.

Secondary outcomes

  1. Intra ocular pressure

    Time frame: 6 months post-procedure

    Intra ocular pressure (IOP) will be recorded.

  2. Central macular thickness (CMT)

    Time frame: 6 months post-procedure

    Central macular thickness (CMT) will be recorded.

  3. Frequency distribution of Fluorescein leakage

    Time frame: 6 months post-procedure

    Frequency distribution of Fluorescein leakage will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Hatem F Abd Elfatah, MD

CONTACT

[email protected]

00201001859927

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 26, 2025
Registry last updated
Jul 1, 2025

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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