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OpenTrials
Completed

NCT Number: NCT02180633

Unveiling Preclinical Idiopathic Macular Hole Formation

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.

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Key information

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Braga Hospital, Braga, Portugal

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Coimbra

Other

Registry information

Acronym: IMH_2012

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 2, 2014
Registry last updated
Jun 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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