Unveiling Preclinical Idiopathic Macular Hole Formation

NCT02180633 | Completed

• 1 other identifier: BBB-BMD/2739/2012
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 7

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.

Conditions

Idiopathic Macular Hole

Keywords

Idiopathic Macular Hole

Outcome Measures

Primary Outcomes (1)

• 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.

  at 1 visit

Study Arms (2)

Fellow Eyes

Patients that suffer from unilateral idiopathic macular hole, and whose fellow eyes don't show any sign of retinal pathology.

Other: Optical Coherence Tomography Scan

Controls

Healthy subjects age-matched to the other group, with no visible retinal pathologies.

Other: Optical Coherence Tomography Scan

Interventions

Optical Coherence Tomography Scan OTHER

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).

Controls; Fellow Eyes

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with unilateral idiopathic macular hole and no other visible retinal pathologies.

You may qualify if:

• normal OCT, with or without vitreous adhesion
• fellow group: unilateral idiopathic macular hole

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Coimbra: lead

Study Sites (7)

Braga Hospital

Braga, 4710-243, Portugal

Location

AIBILI - Association for Innovation and Biomedical Research on Light and Image

Coimbra, 3000-548, Portugal

Location

IBILI - Institute for Biomedical Imaging and Life Sciences

Coimbra, 3000-548, Portugal

Location

North Lisbon Hospital Center

Lisbon, 1649-035, Portugal

Location

St. Maria Hospital

Lisbon, 1649-035, Portugal

Location

St. Antonio Hospital

Porto, 4099-001, Portugal

Location

St. Joao Hospital

Porto, 4200-319, Portugal

Location

Related Publications (6)

• 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

  RESULT

• 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

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

Study Officials

• Rui Bernardes, Ph.D.

  Institute for Biomedical Imaging and Life Sciences, Faculty of Medicine, University of Coimbra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 1, 2014
• First Posted: July 2, 2014
• Study Start: May 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: June 17, 2016

Record last verified: 2016-06

Locations

PT (7)