Prevalence and Risk Factors of Epiretinal Membrane in Diabetic and Non-diabetic Patients

Study Overview
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Brief Summary
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Numerous terms have been used to describe epiretinal membrane (ERM): macular pucker, epimacular membrane, surface-wrinkling retinopathy, cellophane maculopathy and preretinal macular fibrosis. It is, by definition, a fibrocellular tissue found on the inner surface of the retina. It is semi-translucent and proliferates on or above the surface of the internal limiting membrane. It causes blurring and metamorphopsia, while mild cases are often asymptomatic. ERM presence can degrade the acuity and the quality of vision, thus affecting the quality of life. There is evidence that it also has an adverse impact to the treatment options for patients suffering from macular disorders. More specifically, regarding to diabetic retinopathy, ERM seems to have a bidirectional etiopathogenetic relationship with its course and complications. The aim of this study is to know the prevalence of ERM in the Brussel's population, the risk factors predisposing to ERM formation and if diabetic patients have a significantly higher prevalence of ERM in comparison to general population.

Official Title
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Prevalence and Risk Factors of Epiretinal Membrane in Diabetic and Non-diabetic Patients: a Prospective, Cross-sectional and Comparative Study

Conditions
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Epiretinal Membrane

Intervention / Treatment
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* Device: Slit lamp examination
* Device: Undilated 7-field color fundus photography
* Device: Color scan
* Device: Spectral domain optical coherence tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Subjects examined in the general or diabetes screening consultations of the Ophthalmology Department of the CHU Brugmann Hospital Exclusion Criteria: Women pregnant or breast-feeding Hypersensitivity to tropicamide Any macular pathology other than diabetic maculopathy Prior retinal photocoagulation Prior intravitreal injection Prior retinal surgery

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>Patients diagnosed with diabetes mellitus, type 1 or type 2, aged 15 years or older | Device: Slit lamp examination<br>* The slit lamp is an instrument consisting of a high-intensity light source that can be focused to shine a thin sheet of light into the eye.Examination performed without pupil dilatation.<br>Device: Undilated 7-field color fundus photography<br>* Undilated 7-field color fundus photography with Cobra fundus camera. The examination will be done without pupil dilatation; but in case of very small pupils one drop of tropicamide will be instilled, after anterior segment observation with the slit lamp. Two ophthalmologists will assess fundus photos and OCT (Spectral domain optical coherence tomography) frames, to determine whether or not an ERM is present.<br>Device: Color scan<br>* Multicolor photo. The examination will be done without pupil dilatation; but in case of very small pupils one drop of tropicamide will be instilled, after anterior segment observation with the slit lamp.<br>Device: Spectral domain optical coherence tomography<br>* Spectral domain optical coherence tomography (OCT) with Heidelberg Retina Tomography device. The examination will be done without pupil dilatation; but in case of very small pupils one drop of tropicamide will be instilled, after anterior segment observation with the slit lamp.Two ophthalmologists will assess fundus photos and OCT frames, to determine whether or not an ERM is present.<br>|
| Group B<br>Patients non-diagnosed with diabetes mellitus, aged 15 years or older | Device: Slit lamp examination<br>* The slit lamp is an instrument consisting of a high-intensity light source that can be focused to shine a thin sheet of light into the eye.Examination performed without pupil dilatation.<br>Device: Undilated 7-field color fundus photography<br>* Undilated 7-field color fundus photography with Cobra fundus camera. The examination will be done without pupil dilatation; but in case of very small pupils one drop of tropicamide will be instilled, after anterior segment observation with the slit lamp. Two ophthalmologists will assess fundus photos and OCT (Spectral domain optical coherence tomography) frames, to determine whether or not an ERM is present.<br>Device: Color scan<br>* Multicolor photo. The examination will be done without pupil dilatation; but in case of very small pupils one drop of tropicamide will be instilled, after anterior segment observation with the slit lamp.<br>Device: Spectral domain optical coherence tomography<br>* Spectral domain optical coherence tomography (OCT) with Heidelberg Retina Tomography device. The examination will be done without pupil dilatation; but in case of very small pupils one drop of tropicamide will be instilled, after anterior segment observation with the slit lamp.Two ophthalmologists will assess fundus photos and OCT frames, to determine whether or not an ERM is present.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age | Age | First standard of care consultation, up to 3 months | 
| Gender | Gender | First standard of care consultation, up to 3 months | 
| Population sub-type | Population sub-type: Caucasian, African, Asian, Indian, American or Other | First standard of care consultation, up to 3 months | 
| Diabetes type (for group A) | Diabetes type (for group A) | First standard of care consultation, up to 3 months | 
| Diabetic Retinopathy classification | Diabetic Retinopathy classification, if diagnosed (according to the Early Treatment of Diabetic Retinopathy Study (ETDRS) classification) | First standard of care consultation, up to 3 months | 
| Duration of medical treatment of diabetes | Duration of medical treatment of diabetes (measured in months) | First standard of care consultation, up to 3 months | 
| HbA1C (Glycated Haemoglobin) rate | HbA1C rate (according to recent blood test) | First standard of care consultation, up to 3 months | 
| Smoking status | Smoking status | First standard of care consultation, up to 3 months | 
| Previous cataract surgery | Previous cataract surgery | First standard of care consultation, up to 3 months | 
| Diagnose of ERM | Diagnose of ERM | First standard of care consultation, up to 3 months | 
| Educational level | Educational level | First standard of care consultation, up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epiretinal Membrane, Diabetes