Epiretinal Membrane in Patients With DR.

NCT07241845 | Not Yet Recruiting

• 1 other identifier: epiretinal membrane in OCT
• Study Type: observational
• Target: 225
• Locations: 0 countries
• Sites: N/A

Brief Summary

To report the prevalence of ERM among patients with diabetic retinopathy, and the possible associated risk factors.

Conditions

Epiretinal Membrane

Keywords

oct

Outcome Measures

Primary Outcomes (1)

• frequency of ERM among patients presented with diabetic retinopathy

  one year

Secondary Outcomes (1)

• detection of possible associated risk factors including age, gender, type and duration and control of diabetes, hypertension, IHD, diabetic nephropathy, severity of diabetic retinopathy.

  two years

Interventions

OCT RADIATION

All the patients will undergo OCT imaging using NIDEK RS-330 Retina scan duo 2 (SD-OCT)(CO-LTD made in Japan 2017) with scan speed 70.000 axial scans per second and wavelength of 880 nm. A three-dimensional scan protocol will be used for macular measurements. Macular scans will be performed with axial scanning protocols covering a 9 × 9 mm area centered on the fovea. OCT images will be evaluated by a trained ophthalmologist for the following: \- Stage of ERM will be classified by Govetto et al system into stage 1,2,3 or 4. Stage 1: ERMs were mild and thin. Foveal depression is present. Stage 2: ERMs with a widening of the outer nuclear layer and loss of the foveal depression. Stage 3: ERMs with continuous ectopic inner foveal layers crossing the entire foveal area. Stage 4: ERMs were thick with continuous ectopic inner foveal layers and disrupted retinal layers. \- central macular thickness CMT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

diabetic patients above 18 years of age.

You may qualify if:

• Patients aged 18 years or older.
• Patients with ERM confirmed by OCT images.
• Patients with DM with varying severity of diabetic retinopathy.

You may not qualify if:

• History of previous eye trauma or surgery other than uneventful cataract surgery, uveitis, history of retinal detachment, media opacity impairing the quality OCT images, high myopia, macular or retinal diseases disease affecting the visual acuity other than diabetic retinopathy, e.g. macular hole, retinitis pigmentosa, AMD, CRVO.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• Kakihara S, AbdelSalam M, Zhuang K, Fawzi AA. Epiretinal Membrane Is Associated with Diabetic Retinopathy Severity and Cumulative Anti-VEGF Injections. Ophthalmol Sci. 2025 Feb 7;5(3):100733. doi: 10.1016/j.xops.2025.100733. eCollection 2025 May-Jun.

  PMID: 40161463 BACKGROUND

• Bu SC, Kuijer R, Li XR, Hooymans JM, Los LI. Idiopathic epiretinal membrane. Retina. 2014 Dec;34(12):2317-35. doi: 10.1097/IAE.0000000000000349.

  PMID: 25360790 BACKGROUND

MeSH Terms

Conditions

Epiretinal Membrane; Ornithine Carbamoyltransferase Deficiency Disease

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Urea Cycle Disorders, Inborn; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

merna maged, resident doctor

CONTACT

+201284143158; mernamaged1@gmail.com

salma kedwany, MD

CONTACT

+201062330885; salmakedwany@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: November 21, 2025

Record last verified: 2025-11