Clinical Trials Directory

Trials / Completed

CompletedNCT02180633

Unveiling Preclinical Idiopathic Macular Hole Formation

Status
Completed
Phase
Study type
Observational
Enrollment
200 (actual)
Sponsor
University of Coimbra · Academic / Other
Sex
All
Age
45 Years – 80 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHEROptical 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).

Timeline

Start date
2013-05-01
Primary completion
2015-09-01
Completion
2015-09-01
First posted
2014-07-02
Last updated
2016-06-17

Locations

7 sites across 1 country: Portugal

Source: ClinicalTrials.gov record NCT02180633. Inclusion in this directory is not an endorsement.