Idiopathic Macular HoleIMH_2012NCT02180633
Unveiling Preclinical Idiopathic Macular Hole Formation
An observational study of Idiopathic Macular Hole, run by University of Coimbra at 7 sites in Portugal.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Macular Hole
- What is being tested?
- Optical Coherence Tomography Scan
- How many people
- 200 participants
- Where
- 7 sitesPortugal
- Study dates
- May 2013to Sep 2015
- 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with unilateral idiopathic macular hole and no other visible retinal pathologies.
Who may be able to join
- normal OCT, with or without vitreous adhesion
- fellow group: unilateral idiopathic macular hole
Who cannot join
- OCT with vitreous adhesion
- lamellar or pseudoholes
- inner retinal surface alterations
- myopia(>4D)
- glaucoma
- significative media opacity
Show all 11Show fewer
- previous retina photocoagulation
- any type of intraocular surgery in the last 6 months
- intravitreal medication
- diabetes or neurodegenerative diseases
- macular hole secondary to trauma
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Portugal7 sites
Braga Hospital
Braga, 4710-243
AIBILI - Association for Innovation and Biomedical Research on Light and Image
Coimbra, 3000-548
IBILI - Institute for Biomedical Imaging and Life Sciences
Coimbra, 3000-548
North Lisbon Hospital Center
Lisbon, 1649-035
St. Maria Hospital
Lisbon, 1649-035
St. Antonio Hospital
Porto, 4099-001
St. Joao Hospital
Porto, 4200-319
About this study
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.
Read the 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.
- Conditions
- Idiopathic Macular Hole
- Being tested
- Optical Coherence Tomography Scan
- Keywords
- Idiopathic Macular Hole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence Tomography ScanOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Fellow Eyes | Patients that suffer from unilateral idiopathic macular hole, and whose fellow eyes don't show any sign of retinal pathology. Receives: Other: Optical Coherence Tomography Scan | |
| Controls | Healthy subjects age-matched to the other group, with no visible retinal pathologies. Receives: Other: Optical Coherence Tomography Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular Topography
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.
Measured: at 1 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startMay 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Macular HoleStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rui Bernardes, University of Coimbra
- Investigators
- Rui Bernardes, Ph.D., Principal investigator, Institute for Biomedical Imaging and Life Sciences, Faculty of Medicine, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180633
- Sponsor's protocol ID
- BBB-BMD/2739/2012
- Acronym
- IMH_2012
- Status last verified
- Jun 2016
- First submitted
- 1 Jul 2014
- Last updated
- 17 Jun 2016
- Results posted
- No
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 at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unveiling Preclinical Idiopathic Macular Hole Formation
- ClinicalTrials.gov ID
- NCT02180633
- Acronym / sponsor ID
- IMH_2012 / BBB-BMD/2739/2012
- Conditions
- Idiopathic Macular Hole
- Keywords
- Idiopathic Macular Hole
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 2 Jul 2014 (estimated)
- 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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fellow Eyes | – | Other: Optical Coherence Tomography ScanPatients that suffer from unilateral idiopathic macular hole, and whose fellow eyes don't show any sign of retinal pathology. |
| Controls | – | Other: Optical Coherence Tomography ScanHealthy subjects age-matched to the other group, with no visible retinal pathologies. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with unilateral idiopathic macular hole and no other visible retinal pathologies.
Key inclusion criteria (2 listed)
- normal OCT, with or without vitreous adhesion
- fellow group: unilateral idiopathic macular hole
Key exclusion criteria (11 listed)
- OCT with vitreous adhesion
- lamellar or pseudoholes
- inner retinal surface alterations
- myopia(>4D)
- glaucoma
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 |
|---|---|---|
| Optical Coherence Tomography ScanAs 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). | Other | Controls, Fellow Eyes |
Primary outcome
Macular Topography
Time frame: at 1 visit
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.
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 17 Jun 2016.
- Results publicationH. 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
- Results publicationP. 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
- Results publicationJ. 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.
- Results publicationA. 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.
- Results publicationFigueira, 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.
- Results publicationSilva, 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.
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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.
Rui Bernardes, Ph.D. principal investigator
Institute for Biomedical Imaging and Life Sciences, Faculty of Medicine, University of Coimbra
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Macular Hole, run by University of Coimbra at 7 sites in Portugal.
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 2 inclusion and 11 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 17 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Portugal. 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?
Macular Topography (time frame: at 1 visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02180633, which also lists 6 linked publications.
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 17 Jun 2016.