Epiretinal Membrane in Patients With DR.
ConditionEpiretinal Membrane
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University
About this trial
To report the prevalence of ERM among patients with diabetic retinopathy, and the possible associated risk factors.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients aged 18 years or older.
Patients with ERM confirmed by OCT images.
Patients with DM with varying severity of diabetic retinopathy.
Disqualifiers
• 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.
Trial population
diabetic patients above 18 years of age.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
OCT
RadiationAll 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
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
frequency of ERM among patients presented with diabetic retinopathy
Time frame
one yearSecondary 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.
Time frame
two yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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