Non-Center Involving Diabetic Macular Edema Progression in Early Postoperative Period After Phacoemulsification
NCT ID: NCT07038967
Last Updated: 2025-07-01
Study Results
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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RECRUITING
50 participants
OBSERVATIONAL
2025-06-29
2025-12-01
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
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
Coloured photography will be performed preoperatively and at 3 and 6 months postoperatively.
Fluorescein angiography
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
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.
Fluorescein angiography
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
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.
Eligibility Criteria
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Inclusion Criteria
* Both sexes.
* Patients with Grade I - Grade II nuclear cataract and non-center-involving diabetic macular edema (NCIDME).
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Hatem Fawzy Abd Elfatah Abo saif
Lecturer of Ophthalmology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
Locations
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Ain Shams University
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FMASU R127/2025
Identifier Type: -
Identifier Source: org_study_id
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