Menu
Recruiting NCT05294978

EyeConic: Qualification for Cone-Optogenetics

Observational Retinal Dystrophies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Optical coherence tomography (OCT).
Who it may be relevant to
Registry conditions: Retinal Dystrophies. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, China, Germany, Hungary, Italy +2
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Qualification for Cone-Optogenetics (EyeConic)

Overview

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.

Detailed 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.

Interventions

  • Diagnostic test Optical coherence tomography (OCT)
    Data of macular optical coherence tomography (OCT)

Primary outcome measures

  • OCT - Central retinal volume [Time frame: Baseline (about 10 minutes)]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 3 centers
  • University of California San Francisco, Department of Ophthalmology — San Francisco
  • Bascom Palmer Eye Institute — Miami
  • University of Pittsburgh, Department of Ophthalmology — Pittsburgh
China · 1 center
  • Beijing Institute of Ophthalmology — Beijing
Germany · 1 center
  • Universitätsklinikum Tübingen Augenklinik — Tübingen
Hungary · 1 center
  • Semmelweis University, Department of Ophthalmology — Budapest
Italy · 1 center
  • Oculista Ospedale Parma — Parma
Switzerland · 1 center
  • University Hospital Basel, Eye Clinic — Basel
United Kingdom · 1 center
  • Moorfields Eye Hospital — London

Identifiers

NCT: NCT05294978 · IOB_EyeConic_2021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗