Unveiling Preclinical Idiopathic Macular Hole Formation

Idiopathic Macular Hole Clinical Trial

— IMH_2012  

Official title:

Unveiling Preclinical Idiopathic Macular Hole Formation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02180633
• Other study ID #: BBB-BMD/2739/2012
• Status: Completed
• Phase: N/A
• First received: July 1, 2014
• Last updated: June 16, 2016
• Start date: May 2013
• Est. completion date: September 2015

Study information

• Verified date: June 2016
• Source: University of Coimbra
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Ethics Committee for Clinical Research
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 80 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Idiopathic Macular Hole
• Retinal Perforations

Intervention

Other:
• Optical Coherence Tomography Scan
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).

Locations

Country	Name	City	State
Portugal	Braga Hospital	Braga
Portugal	AIBILI - Association for Innovation and Biomedical Research on Light and Image	Coimbra
Portugal	IBILI - Institute for Biomedical Imaging and Life Sciences	Coimbra
Portugal	North Lisbon Hospital Center	Lisbon
Portugal	St. Maria Hospital	Lisbon
Portugal	St. Antonio Hospital	Porto
Portugal	St. Joao Hospital	Porto

Sponsors (1)

Lead Sponsor	Collaborator
University of Coimbra

Country where clinical trial is conducted

Portugal, 

References & Publications (6)

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 So

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

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

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

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 a

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No