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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03362580
Other study ID # CHUB-ERM
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 12, 2017
Est. completion date October 10, 2019

Study information

Verified date July 2020
Source Brugmann University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date October 10, 2019
Est. primary completion date October 10, 2019
Accepts healthy volunteers No
Gender All
Age group 15 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.
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.

Locations

Country Name City State
Belgium CHU Brugmann Brussels

Sponsors (1)

Lead Sponsor Collaborator
Laurence Postelmans

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Age Age First standard of care consultation, up to 3 months
Primary Gender Gender First standard of care consultation, up to 3 months
Primary Population sub-type Population sub-type: Caucasian, African, Asian, Indian, American or Other First standard of care consultation, up to 3 months
Primary Diabetes type (for group A) Diabetes type (for group A) First standard of care consultation, up to 3 months
Primary 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
Primary Duration of medical treatment of diabetes Duration of medical treatment of diabetes (measured in months) First standard of care consultation, up to 3 months
Primary HbA1C (Glycated Haemoglobin) rate HbA1C rate (according to recent blood test) First standard of care consultation, up to 3 months
Primary Smoking status Smoking status First standard of care consultation, up to 3 months
Primary Previous cataract surgery Previous cataract surgery First standard of care consultation, up to 3 months
Primary Diagnose of ERM Diagnose of ERM First standard of care consultation, up to 3 months
Primary Educational level Educational level First standard of care consultation, up to 3 months
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