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

ConditionsNon-CenterDiabetic Macular EdemaPhacoemulsification
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAin Shams University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years.

Both sexes.

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

Disqualifiers

Traumatic cataract.

Severe Non-Proliferative/ Proliferative Diabetic Retinopathy.

Marked Asymmetry of retinopathy between both eyes.

Mature senile cataract or severe lens opacity.

Trial 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Coloured photography

    Other intervention

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

  • Fluorescein angiography

    Other intervention

    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 intervention

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Study group3 interventions

Trial outcomes

Primary outcomes

1

Best Corrected Visual Acuity

Best Corrected Visual Acuity (BCVA) will be recorded.

Time frame
6 months post-procedure

Secondary outcomes

1

Intra ocular pressure

Intra ocular pressure (IOP) will be recorded.

Time frame
6 months post-procedure
2

Central macular thickness (CMT)

Central macular thickness (CMT) will be recorded.

Time frame
6 months post-procedure
3

Frequency distribution of Fluorescein leakage

Frequency distribution of Fluorescein leakage will be recorded.

Time frame
6 months post-procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov
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