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

Prevalence and Risk Factors of Epiretinal Membrane in Diabetic and Non-diabetic Patients: a Prospective, Cross-sectional and Comparative Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03362580
Enrollment
200
Registered
2017-12-05
Start date
2017-12-12
Completion date
2019-10-10
Last updated
2020-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epiretinal Membrane

Keywords

Epiretinal Membrane, Diabetes

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.

Interventions

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.

DEVICEUndilated 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.

DEVICEColor 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.

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.

Sponsors

Laurence Postelmans
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
AgeFirst standard of care consultation, up to 3 monthsAge
GenderFirst standard of care consultation, up to 3 monthsGender
Population sub-typeFirst standard of care consultation, up to 3 monthsPopulation sub-type: Caucasian, African, Asian, Indian, American or Other
Diabetes type (for group A)First standard of care consultation, up to 3 monthsDiabetes type (for group A)
Diabetic Retinopathy classificationFirst standard of care consultation, up to 3 monthsDiabetic Retinopathy classification, if diagnosed (according to the Early Treatment of Diabetic Retinopathy Study (ETDRS) classification)
Duration of medical treatment of diabetesFirst standard of care consultation, up to 3 monthsDuration of medical treatment of diabetes (measured in months)
HbA1C (Glycated Haemoglobin) rateFirst standard of care consultation, up to 3 monthsHbA1C rate (according to recent blood test)
Smoking statusFirst standard of care consultation, up to 3 monthsSmoking status
Previous cataract surgeryFirst standard of care consultation, up to 3 monthsPrevious cataract surgery
Diagnose of ERMFirst standard of care consultation, up to 3 monthsDiagnose of ERM
Educational levelFirst standard of care consultation, up to 3 monthsEducational level

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026