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

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

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.

Study Overview

• Status: Completed
• Conditions: Epiretinal Membrane
• Intervention / Treatment: Device: Slit lamp examination; Device: Undilated 7-field color fundus photography; Device: Color scan; Device: Spectral domain optical coherence tomography

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • CHU Brugmann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects examined in the general or diabetes screening consultations of the Ophtalmology Department of the CHU Brugmann Hospital

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Laurence Postelmans
• Investigators: Principal Investigator: Laurence Postelmans, MD, CHU Brugmann

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2017
• Primary Completion (Actual): October 10, 2019
• Study Completion (Actual): October 10, 2019

Study Registration Dates

• First Submitted: November 16, 2017
• First Submitted That Met QC Criteria: November 29, 2017
• First Posted (Actual): December 5, 2017

Study Record Updates

• Last Update Posted (Actual): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Diabetes; Epiretinal Membrane
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Epiretinal Membrane
• Other Study ID Numbers: CHUB-ERM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No