Epiretinal Membrane Clinical Trial
Official title:
Prevalence and Risk Factors of Epiretinal Membrane in Diabetic and Non-diabetic Patients: a Prospective, Cross-sectional and Comparative Study
NCT number | NCT03362580 |
Other study ID # | CHUB-ERM |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 12, 2017 |
Est. completion date | October 10, 2019 |
Verified date | July 2020 |
Source | Brugmann University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | October 10, 2019 |
Est. primary completion date | October 10, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | CHU Brugmann | Brussels |
Lead Sponsor | Collaborator |
---|---|
Laurence Postelmans |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Age | Age | First standard of care consultation, up to 3 months | |
Primary | Gender | Gender | First standard of care consultation, up to 3 months | |
Primary | Population sub-type | Population sub-type: Caucasian, African, Asian, Indian, American or Other | First standard of care consultation, up to 3 months | |
Primary | Diabetes type (for group A) | Diabetes type (for group A) | First standard of care consultation, up to 3 months | |
Primary | Diabetic Retinopathy classification | Diabetic Retinopathy classification, if diagnosed (according to the Early Treatment of Diabetic Retinopathy Study (ETDRS) classification) | First standard of care consultation, up to 3 months | |
Primary | Duration of medical treatment of diabetes | Duration of medical treatment of diabetes (measured in months) | First standard of care consultation, up to 3 months | |
Primary | HbA1C (Glycated Haemoglobin) rate | HbA1C rate (according to recent blood test) | First standard of care consultation, up to 3 months | |
Primary | Smoking status | Smoking status | First standard of care consultation, up to 3 months | |
Primary | Previous cataract surgery | Previous cataract surgery | First standard of care consultation, up to 3 months | |
Primary | Diagnose of ERM | Diagnose of ERM | First standard of care consultation, up to 3 months | |
Primary | Educational level | Educational level | First standard of care consultation, up to 3 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03332758 -
Inflammasomes in Cell Death in FTMH, ERM, and RRD
|
||
Active, not recruiting |
NCT04130841 -
Effects of Internal Limiting Membrane Peeling on Visual Function in Epiretinal Membrane Surgery
|
N/A | |
Recruiting |
NCT03713268 -
Intraoperative OCT Guidance of Intraocular Surgery II
|
||
Terminated |
NCT01532765 -
Randomized Trial Comparing Epiretinal Membrane Surgery With and Without Internal Limiting Membrane Removal
|
N/A | |
Completed |
NCT01474655 -
Retinal Layers and Visual Rehabilitation After Epiretinal Membrane Removal
|
N/A | |
Active, not recruiting |
NCT04120311 -
Episcleral Dexamethasone for Treatment of Macular Edema and Inflammatory Disorders of the Posterior Pole
|
Phase 1 | |
Completed |
NCT04445142 -
Fovea ERM After Fovea-sparing ILM Peeling
|
||
Recruiting |
NCT01701518 -
A Pilot Study of the Effectiveness of Intra-operative Ozurdex® in Vitrectomy Surgery for Epiretinal Membranes
|
N/A | |
Completed |
NCT01627977 -
Association of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy
|
Phase 3 | |
Completed |
NCT00408720 -
Comparison of a Spectral OCT/SLO With the Stratus OCT for Imaging Various Retinal Pathologies
|
N/A | |
Completed |
NCT01771939 -
Phacoemulsification and 25 Gauge (25G) Vitrectomy Versus Phacoemulsification Only in Idiopathic Epiretinal Membranes
|
N/A | |
Completed |
NCT05171621 -
Measuring Subjective Quality of Vision and Metamorphopsia Before and After Epiretinal Membrane and Macular Hole Surgery
|
||
Active, not recruiting |
NCT04306718 -
Cultivation of Hyalocytes From ILM and ERM Samples: a Pilot Study
|
N/A | |
Recruiting |
NCT01985490 -
Change in Foveal Avascular Zone After Removal of Epiretinal Membrane and Internal Limiting Membrane
|
N/A | |
Completed |
NCT01238393 -
Treatment of Epiretinal Membranes With Ranibizumab
|
N/A | |
Terminated |
NCT00333060 -
Study of OT-551 Eye Drops to Prevent or Delay Progression of Nuclear Cataracts Following Vitreous Removal
|
Phase 2 | |
Completed |
NCT05287269 -
Ocular Coherence Tomography During Cataract Assessment
|
||
Recruiting |
NCT05138315 -
Quantification of Metamorphopsia in Patients With Epiretinal Membranes
|
N/A | |
Recruiting |
NCT03661593 -
Aniseikonia in Epiretinal Membrane Patients
|
N/A | |
Completed |
NCT03457584 -
Effect of Air-tamponade on Intraretinal Cystoid Changes After Membrane Peeling
|
N/A |