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

Epiretinal Membrane Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03362580
• Other study ID #: CHUB-ERM
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Epiretinal Membrane

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