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

L

Laurence Postelmans

Status

Completed

Conditions

Epiretinal Membrane

Treatments

Device: Spectral domain optical coherence tomography
Device: Color scan
Device: Slit lamp examination
Device: Undilated 7-field color fundus photography

Study type

Observational

Funder types

Other

Identifiers

NCT03362580
CHUB-ERM

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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