Epiretinal MembraneNCT03362580
Prevalence and Risk Factors of Epiretinal Membrane in Diabetic and Non-diabetic Patients
An observational study of Epiretinal Membrane, run by Laurence Postelmans at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Epiretinal Membrane
- What is being tested?
- Slit lamp examination, Undilated 7-field color fundus photography and Color scan
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Dec 2017to 10 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects examined in the general or diabetes screening consultations of the Ophtalmology Department of the CHU Brugmann Hospital
Who may be able to join
- -Subjects examined in the general or diabetes screening consultations of the Ophthalmology Department of the CHU Brugmann Hospital
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence and Risk Factors of Epiretinal Membrane in Diabetic and Non-diabetic Patients: a Prospective, Cross-sectional and Comparative Study
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.
- Conditions
- Epiretinal Membrane
- Being tested
- Slit lamp examination, Undilated 7-field color fundus photography, Color scan, Spectral domain optical coherence tomography
- Keywords
- Epiretinal Membrane, Diabetes
- Medical subject headings
- Epiretinal Membrane, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Patients diagnosed with diabetes mellitus, type 1 or type 2, aged 15 years or older Receives: Device: Slit lamp examination; Device: Undilated 7-field color fundus photography; Device: Color scan; Device: Spectral domain optical coherence tomography | |
| Group B | Patients non-diagnosed with diabetes mellitus, aged 15 years or older Receives: Device: Slit lamp examination; Device: Undilated 7-field color fundus photography; Device: Color scan; Device: Spectral domain optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
Age
Measured: First standard of care consultation, up to 3 months
Gender
Gender
Measured: First standard of care consultation, up to 3 months
Population sub-type
Population sub-type: Caucasian, African, Asian, Indian, American or Other
Measured: First standard of care consultation, up to 3 months
Diabetes type (for group A)
Diabetes type (for group A)
Measured: 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)
Measured: First standard of care consultation, up to 3 months
Duration of medical treatment of diabetes
Duration of medical treatment of diabetes (measured in months)
Measured: First standard of care consultation, up to 3 months
HbA1C (Glycated Haemoglobin) rate
HbA1C rate (according to recent blood test)
Measured: First standard of care consultation, up to 3 months
Smoking status
Smoking status
Measured: First standard of care consultation, up to 3 months
Previous cataract surgery
Previous cataract surgery
Measured: First standard of care consultation, up to 3 months
Diagnose of ERM
Diagnose of ERM
Measured: First standard of care consultation, up to 3 months
Educational level
Educational level
Measured: First standard of care consultation, up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start12 Dec 2017
- Primary completion10 Oct 2019
- Study completion10 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epiretinal MembraneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laurence Postelmans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Laurence Postelmans, Brugmann University Hospital
- Investigators
- Laurence Postelmans, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362580
- Sponsor's protocol ID
- CHUB-ERM
- Status last verified
- Jul 2020
- First submitted
- 16 Nov 2017
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Risk Factors of Epiretinal Membrane in Diabetic and Non-diabetic Patients: a Prospective, Cross-sectional and Comparative Study
- ClinicalTrials.gov ID
- NCT03362580
- Acronym / sponsor ID
- CHUB-ERM
- Conditions
- Epiretinal Membrane
- Keywords
- Epiretinal Membrane, Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Laurence PostelmansUniversity, hospital or other
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 5 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Device: Slit lamp examination, Device: Undilated 7-field color fundus photography, Device: Color scan, Device: Spectral domain optical coherence tomographyPatients diagnosed with diabetes mellitus, type 1 or type 2, aged 15 years or older |
| Group B | – | Device: Slit lamp examination, Device: Undilated 7-field color fundus photography, Device: Color scan, Device: Spectral domain optical coherence tomographyPatients non-diagnosed with diabetes mellitus, aged 15 years or older |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects examined in the general or diabetes screening consultations of the Ophtalmology Department of the CHU Brugmann Hospital
Key inclusion criteria (1 listed)
- -Subjects examined in the general or diabetes screening consultations of the Ophthalmology Department of the CHU Brugmann Hospital
Key exclusion criteria (6 listed)
- Women pregnant or breast-feeding
- Hypersensitivity to tropicamide
- Any macular pathology other than diabetic maculopathy
- Prior retinal photocoagulation
- Prior intravitreal injection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Slit lamp examinationThe 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 | Group A, Group B |
| Undilated 7-field color fundus photographyUndilated 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 | Group A, Group B |
| Color scanMulticolor 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 | Group A, Group B |
| Spectral domain optical coherence tomographySpectral 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. | Device | Group A, Group B |
Primary outcome
Age
Time frame: First standard of care consultation, up to 3 months
Age
Gender
Time frame: First standard of care consultation, up to 3 months
Gender
Population sub-type
Time frame: First standard of care consultation, up to 3 months
Population sub-type: Caucasian, African, Asian, Indian, American or Other
Diabetes type (for group A)
Time frame: First standard of care consultation, up to 3 months
Diabetes type (for group A)
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)
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)
HbA1C (Glycated Haemoglobin) rate
Time frame: First standard of care consultation, up to 3 months
HbA1C rate (according to recent blood test)
Smoking status
Time frame: First standard of care consultation, up to 3 months
Smoking status
Previous cataract surgery
Time frame: First standard of care consultation, up to 3 months
Previous cataract surgery
Diagnose of ERM
Time frame: First standard of care consultation, up to 3 months
Diagnose of ERM
Educational level
Time frame: First standard of care consultation, up to 3 months
Educational level
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurence Postelmans, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epiretinal Membrane, run by Laurence Postelmans at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age (time frame: First standard of care consultation, up to 3 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.