Prevalence and Risk Factors of Epiretinal Membrane in Diabetic and Non-diabetic Patients
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Group A Patients diagnosed with diabetes mellitus, type 1 or type 2, aged 15 years or older |
Device: Slit lamp examination
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.
Device: Undilated 7-field color fundus photography
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.
Device: Color scan
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.
Device: Spectral domain optical coherence tomography
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.
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Group B Patients non-diagnosed with diabetes mellitus, aged 15 years or older |
Device: Slit lamp examination
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.
Device: Undilated 7-field color fundus photography
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.
Device: Color scan
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.
Device: Spectral domain optical coherence tomography
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.
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Outcome Measures
Primary Outcome Measures
- Age [First standard of care consultation, up to 3 months]
Age
- Gender [First standard of care consultation, up to 3 months]
Gender
- Population sub-type [First standard of care consultation, up to 3 months]
Population sub-type: Caucasian, African, Asian, Indian, American or Other
- Diabetes type (for group A) [First standard of care consultation, up to 3 months]
Diabetes type (for group A)
- Diabetic Retinopathy classification [First standard of care consultation, up to 3 months]
Diabetic Retinopathy classification, if diagnosed (according to the Early Treatment of Diabetic Retinopathy Study (ETDRS) classification)
- Duration of medical treatment of diabetes [First standard of care consultation, up to 3 months]
Duration of medical treatment of diabetes (measured in months)
- HbA1C (Glycated Haemoglobin) rate [First standard of care consultation, up to 3 months]
HbA1C rate (according to recent blood test)
- Smoking status [First standard of care consultation, up to 3 months]
Smoking status
- Previous cataract surgery [First standard of care consultation, up to 3 months]
Previous cataract surgery
- Diagnose of ERM [First standard of care consultation, up to 3 months]
Diagnose of ERM
- Educational level [First standard of care consultation, up to 3 months]
Educational level
Eligibility Criteria
Criteria
Inclusion Criteria:
-Subjects examined in the general or diabetes screening consultations of the Ophthalmology Department of the CHU Brugmann Hospital
Exclusion Criteria:
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Women pregnant or breast-feeding
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Hypersensitivity to tropicamide
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Any macular pathology other than diabetic maculopathy
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Prior retinal photocoagulation
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Prior intravitreal injection
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Prior retinal surgery
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | CHU Brugmann | Brussels | Belgium | 1020 |
Sponsors and Collaborators
- Laurence Postelmans
Investigators
- Principal Investigator: Laurence Postelmans, MD, CHU Brugmann
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CHUB-ERM