Clinical trial NCT03362580: Prevalence and Risk Factors of Epiretinal Membrane in Diabetic and Non-diabetic Patients
Official title: Prevalence and Risk Factors of Epiretinal Membrane in Diabetic and Non-diabetic Patients: a Prospective, Cross-sectional and Comparative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epiretinal Membrane
Keywords: Epiretinal Membrane
Diabetes
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2017-12-05
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: Age
timeFrame: First standard of care consultation, up to 3 months
measure: Gender
timeFrame: First standard of care consultation, up to 3 months
measure: Population sub-type
timeFrame: First standard of care consultation, up to 3 months
measure: Diabetes type (for group A)
timeFrame: First standard of care consultation, up to 3 months
measure: Diabetic Retinopathy classification
timeFrame: First standard of care consultation, up to 3 months
measure: Duration of medical treatment of diabetes
timeFrame: First standard of care consultation, up to 3 months
measure: HbA1C (Glycated Haemoglobin) rate
timeFrame: First standard of care consultation, up to 3 months
measure: Smoking status
timeFrame: First standard of care consultation, up to 3 months
measure: Previous cataract surgery
timeFrame: First standard of care consultation, up to 3 months
measure: Diagnose of ERM
timeFrame: First standard of care consultation, up to 3 months
measure: Educational level
timeFrame: First standard of care consultation, up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Laurence Postelmans, MD
role: PRINCIPAL_INVESTIGATOR
References: