Qualification for Cone-Optogenetics

Status: Enrolling

Conditions: Retinal Dystrophies

Study type: Observational

Funder types: Other

Identifiers

NCT05218928

IOB-EyeConic-2021

Details and patient eligibility

About

This study aims to prepare for the first-in-human clinical trial of cone optogenetics vision restoration. As a first step, this worldwide multicenter ocular imaging study (EyeConic Study) is performed to identify eligible patients.

Full description

In a subset of patients with inherited retinal dystrophies (IRDs), cones lose their light-sensitive outer segments but remain alive in a dormant stage. This creates an opportunity to resensitize them through targeted optogenetic tools. However, the true proportion of low vision patients harboring dormant, non-functional cones, is currently unknown. The worldwide multicenter retrospective study (EyeConic) aims to estimate the proportion of low vision patients with remaining cone cell bodies for the first time.

Enrollment: 1,000 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (patients):

Diagnosis of generalized IRD Low vision as defined as visual acuity worse or equal to 0.05 (or 20/400) in the study eye Availability of macular optical coherence tomography (OCT)

Inclusion Criteria (controls):

Normal ophthalmic findings Availability of macular optical coherence tomography (OCT)

Exclusion Criteria (all):

Other eye diseases with a significant effect on vision or retinal structure Extraocular disease affecting retinal structure such as neurodegenerative diseases