Unveiling Preclinical Idiopathic Macular Hole Formation (IMH_2012)

University of Coimbra

Status: Completed

Conditions: Idiopathic Macular Hole

Treatments: Other: Optical Coherence Tomography Scan

Study type: Observational

Funder types: Other

Identifiers

NCT02180633

BBB-BMD/2739/2012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Fellow Eyes

Description:

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

Treatment:

Other: Optical Coherence Tomography Scan

Controls

Description:

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

Treatment:

Other: Optical Coherence Tomography Scan