NCT03362580

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 5, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

December 12, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2019

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

1.8 years

First QC Date

November 16, 2017

Last Update Submit

July 8, 2020

Conditions

Epiretinal Membrane

Keywords

Epiretinal MembraneDiabetes

Outcome Measures

Primary Outcomes (11)

  • 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

Study Arms (2)

Group A

Patients diagnosed with diabetes mellitus, type 1 or type 2, aged 15 years or older

Device: Slit lamp examinationDevice: Undilated 7-field color fundus photographyDevice: Color scanDevice: Spectral domain optical coherence tomography

Group B

Patients non-diagnosed with diabetes mellitus, aged 15 years or older

Device: Slit lamp examinationDevice: Undilated 7-field color fundus photographyDevice: Color scanDevice: Spectral domain optical coherence tomography

Interventions

Slit lamp examinationDEVICE

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.

Group AGroup B
Undilated 7-field color fundus photographyDEVICE

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.

Group AGroup B
Color scanDEVICE

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.

Group AGroup B
Spectral domain optical coherence tomographyDEVICE

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 AGroup B

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Women pregnant or breast-feeding
  • Hypersensitivity to tropicamide
  • Any macular pathology other than diabetic maculopathy
  • Prior retinal photocoagulation
  • Prior intravitreal injection
  • Prior retinal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

MeSH Terms

Conditions

Epiretinal MembraneDiabetes Mellitus

Interventions

Slit Lamp Microscopy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, OphthalmologicalDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Laurence Postelmans, MD

    CHU Brugmann

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of clinic

Study Record Dates

First Submitted

November 16, 2017

First Posted

December 5, 2017

Study Start

December 12, 2017

Primary Completion

October 10, 2019

Study Completion

October 10, 2019

Last Updated

July 9, 2020

Record last verified: 2020-07

Locations

BE(1)