- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02180633
Unveiling Preclinical Idiopathic Macular Hole Formation (IMH_2012)
A macular hole is a rupture in the macula. In terms of pathogenesis, as much as 80% are idiopathic (Idiopathic Macular Hole, IMH). The normal incidence of this condition is about 0.17%; however, there is a 10-29% chance of development of a macular hole in the fellow eye of patients suffering from unilateral macular hole.
Our hypothesis is that embedded in the topography of the retina is information that can allow for discrimination between healthy eyes and eyes with an increased risk of developing IMH. As such, our work aims to develop a system that allows the automatic identification of these eyes.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A macular hole is a rupture in the macula, the central portion of the retina, responsible for sharp, central vision and hence indispensable for most tasks. In terms of pathogenesis, even though some can be related to trauma, as much as 80% are idiopathic (Idiopathic Macular Hole, IMH). It is theorized that antero-posterior and tangential forces are behind this condition; however, no conclusions have been reached. While the normal incidence of this condition is about 0.17%, there is a 10-29% chance of developing a macular hole in the fellow eye of patients suffering from unilateral macular hole.
Our working hypothesis is that embedded in the topography of the retina is information that can allow for discrimination between healthy eyes and eyes with an increased risk of developing IMH. As such, our study consists on the characterisation of the retinal topography of fellow eyes of patients with unilateral IMH but no other visible retinal pathologies, and of eyes from controls subjects in the same approximate age group. From these topographic maps we acquire a series of features (parameters), and using machine learning techniques create a system that separates eyes into one of the groups - healthy or at risk.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Braga, Portugal, 4710-243
- Braga Hospital
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Coimbra, Portugal, 3000-548
- AIBILI - Association for Innovation and Biomedical Research on Light and Image
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Coimbra, Portugal, 3000-548
- IBILI - Institute for Biomedical Imaging and Life Sciences
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Lisbon, Portugal, 1649-035
- North Lisbon Hospital Center
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Lisbon, Portugal, 1649-035
- St. Maria Hospital
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Porto, Portugal, 4099-001
- St. Antonio Hospital
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Porto, Portugal, 4200-319
- St. Joao Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- normal OCT, with or without vitreous adhesion
- fellow group: unilateral idiopathic macular hole
Exclusion Criteria:
- OCT with vitreous adhesion
- lamellar or pseudoholes
- inner retinal surface alterations
- myopia(>4D)
- glaucoma
- significative media opacity
- previous retina photocoagulation
- any type of intraocular surgery in the last 6 months
- intravitreal medication
- diabetes or neurodegenerative diseases
- macular hole secondary to trauma
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Fellow Eyes
Patients that suffer from unilateral idiopathic macular hole, and whose fellow eyes don't show any sign of retinal pathology.
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As an observational study, the only interventive action taken is the acquisition of a non-invasive volumetric image of the retina via optical coherence tomography (OCT).
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Controls
Healthy subjects age-matched to the other group, with no visible retinal pathologies.
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As an observational study, the only interventive action taken is the acquisition of a non-invasive volumetric image of the retina via optical coherence tomography (OCT).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Macular Topography
Time Frame: at 1 visit
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When a patient that fits into the description of either the case or the control group comes in for a routine visit, a routine optical coherence tomography scan is performed.
These scans are non-invasive and common in ophthalmological visits.
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at 1 visit
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rui Bernardes, Ph.D., Institute for Biomedical Imaging and Life Sciences, Faculty of Medicine, University of Coimbra
Publications and helpful links
General Publications
- H. Pereira; M. Alfaiate; T. Santos; L. Pedrosa; M. Mendes; R. Venâncio; J. Figueira; R. Bernardes: Identification of Eyes at Risk of Developing Idiopathic Macular Holes by Support Vector Machines. IBILI Meeting 2011, December 2011
- P. Rodrigues; T. Santos; H. Pereira; J. Figueira; R. Bernardes: Identification of Eyes at Risk of Developing Idiopathic Macular Holes by Support Vector Machines. DOI: 10.1109/ENBENG.2012.6331372
- J. Figueira; H. Pereira; M. Alfaiate; A. R. Santos; T. Santos; L. Pedrosa; M. Mendes; R. Venâncio; R. Bernardes: Identification of Eyes at Risk of Developing Idiopathic Macular Holes by Support Vector Machines. ARVO Annual Meeting 2012. Invest Ophthalmol Vis Sci 2012;53: E-Abstract 5219.
- A. S. Silva, T. Santos, S. Simão, J. Figueira, R. Bernardes: Unveiling preclinical idiopathic macular hole formation: structural changes by high-definition OCT and machine learning. V Annual meeting of IBILI, Coimbra, Portugal, December 12-13 2013.
- Figueira, João; Silva, Ana S. C; Meireles, Angelina; Gomes, Nuno; Ferreira, Natália; Neves, Carlos; Bernardes, Rui. Identificação de Olhos em Risco de Desenvolvimento de Buracos Maculares Idiopáticos (BMI). 56th Congress of the Portuguese Ophthalmology Society. 2013.
- Silva, Ana S. C; Figueira, João; Simão, Sílvia; Gomes, Nuno; Neves, Carlos; Meireles, Angelina; Ferreira, Natália; Bernardes, Rui. 2014. Unveiling Preclinical Idiopathic Macular Hole Formation Using Support Vector Machines, Proceedings of the Biomedical and Health Informatics International Conference, IEEE - EMB Chapter, 2014.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BBB-BMD/2739/2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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