Actively Recruiting
Assessment of Non-Center Involving Diabetic Macular Edema Progression in Early Postoperative Period After Phacoemulsification
Led by Ain Shams University · Updated on 2025-07-01
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates the progression of non-center-involving diabetic macular edema (NCIDME) during the early period after cataract surgery using phacoemulsification. It focuses on diabetic patients who often develop cataracts at a younger age and have a higher risk of vision loss due to diabetic macular edema. The study aims to understand how NCIDME evolves shortly after surgery to better inform patient care. Participants with Grade I to Grade II nuclear cataract and NCIDME will be observed without receiving experimental treatments. Assessments include coloured photography, fluorescein angiography, and optical coherence tomography (OCT) scans, performed before surgery and then at 3 and 6 months afterward. These imaging techniques will help monitor the eye's condition and track changes in the macula and retina over time. During the study, participants' vision will be evaluated using best corrected visual acuity at 6 months post-procedure as the main outcome. Secondary measurements include intraocular pressure, central macular thickness, and the frequency of fluorescein leakage, all assessed at 6 months. The study involves follow-up visits with detailed imaging and eye exams to observe the progression of diabetic eye changes after surgery, with the total participation lasting at least 6 months.
CONDITIONS
Brief Title
Non-Center Involving Diabetic Macular Edema Progression in Early Postoperative Period After Phacoemulsification
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 618 years
- Both sexes
- Patients with Grade I - Grade II nuclear cataract and non-center-involving diabetic macular edema (NCIDME)
You will not qualify if you...
- Traumatic cataract
- Severe Non-Proliferative or Proliferative Diabetic Retinopathy
- Marked asymmetry of retinopathy between both eyes
- Mature senile cataract or severe lens opacity
- Potential need for Phacotrabeculectomy surgery
- Complications during or after the surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo preoperative imaging including coloured photography, fluorescein angiography, and optical coherence tomography (OCT) to assess diabetic macular edema and cataract status.
1 visit (in-person)
Duration - Up to 1 week or until discharge
Participants undergo phacoemulsification surgery for cataract treatment followed by immediate postoperative care.
1 surgical visit and follow-up visits as part of routine care
Duration - 6 months
Participants are monitored postoperatively at 3 and 6 months with repeated coloured photography, fluorescein angiography, and OCT imaging to assess progression of diabetic macular edema and visual acuity outcomes.
2 visits (in-person) at 3 and 6 months postoperatively
Trial Site Locations
Total: 1 location
1
Ain Shams University
Cairo, Egypt, 11591
Actively Recruiting
Research Team
H
Hatem F Abd Elfatah, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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