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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03362580
Recruitment Status : Completed
First Posted : December 5, 2017
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
Laurence Postelmans, Brugmann University Hospital

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

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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 : December 12, 2017
Actual Primary Completion Date : October 10, 2019
Actual Study Completion Date : October 10, 2019

Resource links provided by the National Library of Medicine


Group/Cohort 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.




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects examined in the general or diabetes screening consultations of the Ophtalmology Department of the CHU Brugmann Hospital
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362580


Locations
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Belgium
CHU Brugmann
Brussels, Belgium, 1020
Sponsors and Collaborators
Laurence Postelmans
Investigators
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Principal Investigator: Laurence Postelmans, MD CHU Brugmann
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Responsible Party: Laurence Postelmans, Head of clinic, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT03362580    
Other Study ID Numbers: CHUB-ERM
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laurence Postelmans, Brugmann University Hospital:
Epiretinal Membrane
Diabetes
Additional relevant MeSH terms:
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Epiretinal Membrane
Retinal Diseases
Eye Diseases