An observational study in Epiretinal Membrane, sponsored by Laurence Postelmans. Completed at 1 site in Belgium. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2020-07-09.
Sponsored by Laurence Postelmans · Observational
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.
Subjects examined in the general or diabetes screening consultations of the Ophtalmology Department of the CHU Brugmann Hospital
-Subjects examined in the general or diabetes screening consultations of the Ophthalmology Department of the CHU Brugmann Hospital
Exclusion Criteria:
Patients diagnosed with diabetes mellitus, type 1 or type 2, aged 15 years or older
Device: Slit lamp examination · Device: Undilated 7-field color fundus photography · Device: Color scan · Device: Spectral domain optical coherence tomography
Patients non-diagnosed with diabetes mellitus, aged 15 years or older
Device: Slit lamp examination · Device: Undilated 7-field color fundus photography · Device: Color scan · Device: Spectral domain optical coherence tomography
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.
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.
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.
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.
Age
Age
Time frame: First standard of care consultation, up to 3 months
Gender
Gender
Time frame: First standard of care consultation, up to 3 months
Population sub-type
Population sub-type: Caucasian, African, Asian, Indian, American or Other
Time frame: First standard of care consultation, up to 3 months
Diabetes type (for group A)
Diabetes type (for group A)
Time frame: 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)
Time frame: First standard of care consultation, up to 3 months
Duration of medical treatment of diabetes
Duration of medical treatment of diabetes (measured in months)
Time frame: First standard of care consultation, up to 3 months
HbA1C (Glycated Haemoglobin) rate
HbA1C rate (according to recent blood test)
Time frame: First standard of care consultation, up to 3 months
Smoking status
Smoking status
Time frame: First standard of care consultation, up to 3 months
Previous cataract surgery
Previous cataract surgery
Time frame: First standard of care consultation, up to 3 months
Diagnose of ERM
Diagnose of ERM
Time frame: First standard of care consultation, up to 3 months
Educational level
Educational level
Time frame: First standard of care consultation, up to 3 months
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Laurence Postelmans