Epidemiologic Assessment of Diabetic Retinopathy in Egypt Using Ultrawide Field Fundus Photographs

Sponsor
Alexandria University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04935749
Collaborator
Joslin Diabetes Center (Other), Harvard Medical School (HMS and HSDM) (Other), I-care Ophthalmology Hospital (Other)
10,000
1
57
175.4

Study Details

Study Description

Brief Summary

In 2013, it was estimated that 16% (7.5 million) of all Egyptian adults between the ages of 20 and 79 years have type 2 diabetes and 2.6 million have diabetic retinopathy. A small pilot study looking at 323 patients with previously diagnosed diabetes mellitus (DM) and 183 patients with newly diagnosed DM found that the prevalence of diabetic retinopathy (DR) was 48.3% and 10.4% in each group respectively. By 2035, the Middle Eastern Region and Egypt is projected to have an over 96% increase in the diabetes population.

Ultrawide field (UWF) imaging is a novel technology that allows the visualization of approximately 82% of the retina in a single image. Its use in diabetic retinopathy (DR) has been widely explored both as a diagnostic as well as a screening tool. Using this technology, more of the peripheral retina can be readily visualized allowing significantly greater hemorrhages/microaneurysms, intraretinal microvascular abnormalities and non-perfusion to be detected. UWF imaging in patients with DM allowed the identification of a distinct sub-set of eyes with lesions that are predominantly distributed in the peripheral retina. Eyes with significantly greater DR lesions in the extended peripheral fields compared to their respective ETDRS fields are said to have predominantly peripheral lesions or PPL. Eyes with PPL are at greater risk of progressing to more advanced DR and developing proliferative diabetic retinopathy (PDR) after 4 years of follow up. The increased risk of vision threatening complications in eyes with PPL has made the identification of these eyes an essential part of DR evaluation and screening. Furthermore, the presence of lesions in the peripheral retina results in a more severe DR grade in approximately 20% of eyes thereby making this tool more accurate at grading DR severity. A recent DRCR retina network multicenter study established earlier findings confirming the validity of this tool in DR management.

I-care Ophthalmology Center will acquire the first UWF device in Egypt, the Optos California (Optos Plc, Dunfermline). Scanning laser ophthalmoscopy UWF imaging has been approved by both the FDA and EMA since 2011. Patients with DM, with or without known DR, will be imaged using the UWF imaging device both for diagnosis and screening purposes at I-care Ophthalmology center after informed consent. These images will be graded for the level of retinopathy and the presence/absence of PPL by certified trained graders. Internal validation and continuous quality control will routinely be conducted. Patients with vision threatening retinopathy (moderate non-proliferative diabetic retinopathy or worse, or the presence of diabetic macular edema) will be instructed to come back for further retinal evaluation and ancillary testing. Patients with mild retinopathy will be instructed to come for yearly follow up imaging. The expected duration for data collection will be 5-years, with interim data analysis on a yearly basis. The design although cross sectional, will have a prospective sub-analysis group in patients who have repeat imaging.

Data collection and imaging will be conducted in Egypt and anonymized deidentified data will be shared with the Joslin Diabetes Center, Harvard Ophthalmology Department for joint research purposes. Data will be analyzed for the prevalence of DR and the distribution of DR severity levels in the studied population. In addition, the presence and absence of PPL and its association with DR progression will be studied. Non-modifiable (duration of DM, age of onset, type of DM etc.) and modifiable risk factors (HbA1c, hypertension, hyperlipidemia etc.) for increased risk of DR progression will also be analyzed. Sensitivity analysis will explore the sensitivity/specificity of initial DR grading compared to trained retina specialists.

Condition or Disease Intervention/Treatment Phase
  • Device: Ultra wide-field retinal imaging

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
10000 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Epidemiologic Assessment of Diabetic Retinopathy in Egypt Using Ultrawide Field Fundus Photographs
Anticipated Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Apr 1, 2026
Anticipated Study Completion Date :
Apr 1, 2026

Outcome Measures

Primary Outcome Measures

  1. Epidemiology [1 year]

    Describing the distribution of different DR severity levels using UWF imaging

  2. DR Progression [4 years]

    Assessing the number of patients with at least 4 years of follow up who have a 2 step or more DR progression

  3. Progression to PDR [4 years]

    Assessing the number of patients with at least 4 years of follow up who progress to PDR

  4. Epidemiology [1 year]

    Prevalence of predominantly peripheral lesions (PPL) in eyes with DR using UWF imaging

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Patients with diabetes mellitus
Exclusion Criteria:
  • Patients unable or unwilling to be imaged

Contacts and Locations

Locations

Site City State Country Postal Code
1 I-care Ophthalmology Center Alexandria Egypt

Sponsors and Collaborators

  • Alexandria University
  • Joslin Diabetes Center
  • Harvard Medical School (HMS and HSDM)
  • I-care Ophthalmology Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Ashraf Elmasry, Lecturer of Ophthalmology, Alexandria University
ClinicalTrials.gov Identifier:
NCT04935749
Other Study ID Numbers:
  • 0305153
First Posted:
Jun 23, 2021
Last Update Posted:
Jun 23, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Mohamed Ashraf Elmasry, Lecturer of Ophthalmology, Alexandria University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 23, 2021