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Completed

NCT Number: NCT03362580

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

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.

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Key information

Conditions

Epiretinal Membrane Diabetes Mellitus Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Retinal Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Brugmann

Brussels, 1020, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Slit lamp examination

Device

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

Device

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

Device

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

Device

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.

Primary outcomes

  1. Age

    Time frame: First standard of care consultation, up to 3 months

    Age

  2. Gender

    Time frame: First standard of care consultation, up to 3 months

    Gender

  3. Population sub-type

    Time frame: First standard of care consultation, up to 3 months

    Population sub-type: Caucasian, African, Asian, Indian, American or Other

  4. Diabetes type (for group A)

    Time frame: First standard of care consultation, up to 3 months

    Diabetes type (for group A)

  5. Diabetic Retinopathy classification

    Time frame: 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)

  6. Duration of medical treatment of diabetes

    Time frame: First standard of care consultation, up to 3 months

    Duration of medical treatment of diabetes (measured in months)

  7. HbA1C (Glycated Haemoglobin) rate

    Time frame: First standard of care consultation, up to 3 months

    HbA1C rate (according to recent blood test)

  8. Smoking status

    Time frame: First standard of care consultation, up to 3 months

    Smoking status

  9. Previous cataract surgery

    Time frame: First standard of care consultation, up to 3 months

    Previous cataract surgery

  10. Diagnose of ERM

    Time frame: First standard of care consultation, up to 3 months

    Diagnose of ERM

  11. Educational level

    Time frame: First standard of care consultation, up to 3 months

    Educational level

Sponsors and collaborators

Lead sponsor

Laurence Postelmans

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 5, 2017
Registry last updated
Jul 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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