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

Sponsor
Laurence Postelmans (Other)
Overall Status
Completed
CT.gov ID
NCT03362580
Collaborator
(none)
200
1
21.9
9.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Slit lamp examination
  • Device: Undilated 7-field color fundus photography
  • Device: Color scan
  • Device: Spectral domain optical coherence tomography

Study Design

Study Type:
Observational
Actual Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prevalence and Risk Factors of Epiretinal Membrane in Diabetic and Non-diabetic Patients: a Prospective, Cross-sectional and Comparative Study
Actual Study Start Date :
Dec 12, 2017
Actual Primary Completion Date :
Oct 10, 2019
Actual Study Completion Date :
Oct 10, 2019

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Age [First standard of care consultation, up to 3 months]

    Age

  2. Gender [First standard of care consultation, up to 3 months]

    Gender

  3. Population sub-type [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) [First standard of care consultation, up to 3 months]

    Diabetes type (for group A)

  5. 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)

  6. Duration of medical treatment of diabetes [First standard of care consultation, up to 3 months]

    Duration of medical treatment of diabetes (measured in months)

  7. HbA1C (Glycated Haemoglobin) rate [First standard of care consultation, up to 3 months]

    HbA1C rate (according to recent blood test)

  8. Smoking status [First standard of care consultation, up to 3 months]

    Smoking status

  9. Previous cataract surgery [First standard of care consultation, up to 3 months]

    Previous cataract surgery

  10. Diagnose of ERM [First standard of care consultation, up to 3 months]

    Diagnose of ERM

  11. Educational level [First standard of care consultation, up to 3 months]

    Educational level

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Brugmann Brussels Belgium 1020

Sponsors and Collaborators

  • Laurence Postelmans

Investigators

  • Principal Investigator: Laurence Postelmans, MD, CHU Brugmann

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Laurence Postelmans, Head of clinic, Brugmann University Hospital
ClinicalTrials.gov Identifier:
NCT03362580
Other Study ID Numbers:
  • CHUB-ERM
First Posted:
Dec 5, 2017
Last Update Posted:
Jul 9, 2020
Last Verified:
Jul 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Laurence Postelmans, Head of clinic, Brugmann University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 9, 2020