Non-Center Involving Diabetic Macular Edema Progression in Early Postoperative Period After Phacoemulsification
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Coloured photography, Fluorescein angiography, Optical coherence tomography.
- Who it may be relevant to
- Registry conditions: Non-Center, Diabetic Macular Edema, Phacoemulsification. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessment of Non-Center Involving Diabetic Macular Edema Progression in Early Postoperative Period After Phacoemulsification
Overview
This study aims to evaluate the progression of non-center-involving diabetic macular edema in the early postoperative period following phacoemulsification.
Detailed 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%.
Interventions
- Other Coloured photography
Coloured photography will be performed preoperatively and at 3 and 6 months postoperatively. - 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: - 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.
Primary outcome measures
- Best Corrected Visual Acuity [Time frame: 6 months post-procedure]
Secondary outcome measures (3)
- Intra ocular pressure [Time frame: 6 months post-procedure]
- Central macular thickness (CMT) [Time frame: 6 months post-procedure]
- Frequency distribution of Fluorescein leakage [Time frame: 6 months post-procedure]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Egypt · 1 center
- Ain Shams University — Cairo
Identifiers
NCT: NCT07038967 · FMASU R127/2025