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

Completed

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

• Registration Number: NCT03362580
• Lead Sponsor: Laurence Postelmans

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-16
• Study First Submitted QC: 2017-11-29
• Study First Posted: 2017-12-05
• Study Start: 2017-12-12
• Primary Completion: 2019-10-10
• Study Completion: 2019-10-10
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-08
• Last Update Posted: 2020-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group B	Color scan	Patients non-diagnosed with diabetes mellitus, aged 15 years or older
Group A	Slit lamp examination	Patients diagnosed with diabetes mellitus, type 1 or type 2, aged 15 years or older
Group B	Slit lamp examination	Patients non-diagnosed with diabetes mellitus, aged 15 years or older
Group B	Spectral domain optical coherence tomography	Patients non-diagnosed with diabetes mellitus, aged 15 years or older
Group A	Spectral domain optical coherence tomography	Patients diagnosed with diabetes mellitus, type 1 or type 2, aged 15 years or older
Group A	Undilated 7-field color fundus photography	Patients diagnosed with diabetes mellitus, type 1 or type 2, aged 15 years or older
Group A	Color scan	Patients diagnosed with diabetes mellitus, type 1 or type 2, aged 15 years or older
Group B	Undilated 7-field color fundus photography	Patients non-diagnosed with diabetes mellitus, aged 15 years or older

Primary Outcome Measures

Name	Time	Method
Educational level	First standard of care consultation, up to 3 months	Educational level
Age	First standard of care consultation, up to 3 months	Age
Previous cataract surgery	First standard of care consultation, up to 3 months	Previous cataract surgery
Gender	First standard of care consultation, up to 3 months	Gender
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)
Smoking status	First standard of care consultation, up to 3 months	Smoking status
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)
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)
Diagnose of ERM	First standard of care consultation, up to 3 months	Diagnose of ERM

Trial Locations

Locations (1)

CHU Brugmann; 🇧🇪 Brussels, Belgium