Early progression of non-center diabetic macular edema after phacoemulsification
Assessment of Non-Center Involving Diabetic Macular Edema Progression in Early Postoperative Period After Phacoemulsification
Ain Shams University · NCT07038967
This will see if non-center-involving diabetic macular edema worsens in the early weeks after cataract surgery in adults with diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ain Shams University (other) |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07038967 on ClinicalTrials.gov |
What this trial studies
Adults with diabetes who have Grade I–II nuclear cataract and non-center-involving diabetic macular edema will be followed before and after phacoemulsification using color fundus photography, fluorescein angiography, and optical coherence tomography. Imaging will be performed preoperatively and at defined early postoperative visits to document any change in retinal thickness or leakage. Patients with severe non-proliferative or proliferative diabetic retinopathy, traumatic or mature cataract, marked asymmetry between eyes, planned combined glaucoma surgery, or surgical complications are excluded. The single-center observational design at Ain Shams University will describe the frequency and timing of early postoperative progression of NCIDME.
Who should consider this trial
Good fit: Adults (age ≥18) with diabetes who have Grade I–II nuclear cataract and non-center-involving diabetic macular edema and are planned for phacoemulsification without severe diabetic retinopathy are ideal candidates.
Not a fit: Patients with severe NPDR/PDR, traumatic or mature cataract, marked asymmetry between eyes, those needing combined phacotrabeculectomy, or those who experience surgical complications are unlikely to gain direct benefit from this observational protocol.
Why it matters
Potential benefit: If successful, findings could help eye doctors detect and manage early worsening of non-center DME after cataract surgery to better preserve vision.
How similar studies have performed: Prior reports have described diabetic macular edema after cataract surgery but prospective data specifically on early progression of non-center-involving DME are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cairo
- Ain Shams University — Cairo, Egypt (RECRUITING)
Study contacts
- Study coordinator: Hatem F Abd Elfatah, MD
- Email: tito78@yahoo.com
- Phone: 00201001859927
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non-Center, Diabetic Macular Edema, Phacoemulsification