MedPath

Unveiling Preclinical Idiopathic Macular Hole Formation

Completed
Conditions
Idiopathic Macular Hole
Interventions
Other: Optical Coherence Tomography Scan
Registration Number
NCT02180633
Lead Sponsor
University of Coimbra
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
200
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

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Fellow EyesOptical Coherence Tomography ScanPatients that suffer from unilateral idiopathic macular hole, and whose fellow eyes don't show any sign of retinal pathology.
ControlsOptical Coherence Tomography ScanHealthy subjects age-matched to the other group, with no visible retinal pathologies.
Primary Outcome Measures
NameTimeMethod
Macular Topographyat 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (7)

IBILI - Institute for Biomedical Imaging and Life Sciences

🇵🇹

Coimbra, Portugal

St. Maria Hospital

🇵🇹

Lisbon, Portugal

St. Antonio Hospital

🇵🇹

Porto, Portugal

St. Joao Hospital

🇵🇹

Porto, Portugal

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

🇵🇹

Coimbra, Portugal

Braga Hospital

🇵🇹

Braga, Portugal

North Lisbon Hospital Center

🇵🇹

Lisbon, Portugal

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