Clinical trial NCT02180633: Unveiling Preclinical Idiopathic Macular Hole Formation
Official title: Unveiling Preclinical Idiopathic Macular Hole Formation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Macular Hole
Keywords: Idiopathic Macular Hole
Lead sponsor: University of Coimbra
Sponsor class: OTHER
First posted: 2014-07-02
Enrollment: 200
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with unilateral idiopathic macular hole and no other visible retinal pathologies.

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Macular Topography
timeFrame: at 1 visit
Secondary outcomes:
Other outcomes:
Locations:
city: Braga
country: Portugal
facility: Braga Hospital
city: Coimbra
country: Portugal
facility: AIBILI - Association for Innovation and Biomedical Research on Light and Image
city: Coimbra
country: Portugal
facility: IBILI - Institute for Biomedical Imaging and Life Sciences
city: Lisbon
country: Portugal
facility: North Lisbon Hospital Center
city: Lisbon
country: Portugal
facility: St. Maria Hospital
city: Porto
country: Portugal
facility: St. Antonio Hospital
city: Porto
country: Portugal
facility: St. Joao Hospital
Study officials:
affiliation: Institute for Biomedical Imaging and Life Sciences, Faculty of Medicine, University of Coimbra
name: Rui Bernardes, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.