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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07038967
Enrollment
50
Registered
2025-06-26
Start date
2025-06-29
Completion date
2025-12-01
Last updated
2025-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Center, Diabetic Macular Edema, Phacoemulsification

Brief summary

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

OTHERColoured photography

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

Fluorescein angiography will be performed preoperatively and at 3 and 6 months postoperatively. The following features will be recorded on each angiography:

OTHEROptical 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.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Best Corrected Visual Acuity6 months post-procedureBest Corrected Visual Acuity (BCVA) will be recorded.

Secondary

MeasureTime frameDescription
Intra ocular pressure6 months post-procedureIntra ocular pressure (IOP) will be recorded.
Central macular thickness (CMT)6 months post-procedureCentral macular thickness (CMT) will be recorded.
Frequency distribution of Fluorescein leakage6 months post-procedureFrequency distribution of Fluorescein leakage will be recorded.

Countries

Egypt

Contacts

Primary ContactHatem F Abd Elfatah, MD
tito78@yahoo.com00201001859927

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026