Qualification for Cone-Optogenetics

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Recruiting
CT.gov ID
NCT05218928
Collaborator
Institute of Molecular and Clinical Ophthalmology Basel, Switzerland (Other)
1,000
9
17
111.1
6.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: OCT

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Qualification for Cone-Optogenetics (EyeConic)
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Patients

-Availability of macular optical coherence tomography (OCT)

Diagnostic Test: OCT
Macular optical coherence tomography (OCT)

Controls

-Availability of macular optical coherence tomography (OCT)

Diagnostic Test: OCT
Macular optical coherence tomography (OCT)

Outcome Measures

Primary Outcome Measures

  1. Foveolar Volume (μm) [Baseline (about 10 minutes)]

    Volume of the foveolar hypercylinder centered around foveal center (μm)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California San Francisco, Department of Ophthalmology San Francisco California United States 94158
2 Bascom Palmer Eye Institute Miami Florida United States 33136
3 University of Pittsburgh, Department of Ophthalmology Pittsburgh Pennsylvania United States 15213
4 Beijing Institute of Ophthalmology Beijing China
5 Universitätsklinikum Tübingen Augenklinik Tübingen Germany
6 Semmelweis University, Department of Ophthalmology Budapest Hungary
7 Oculista Ospedale Parma Parma Italy
8 University Hospital Basel, Eye Clinic Basel Switzerland 4031
9 Moorfields Eye Hospital London United Kingdom

Sponsors and Collaborators

  • University Hospital, Basel, Switzerland
  • Institute of Molecular and Clinical Ophthalmology Basel, Switzerland

Investigators

  • Principal Investigator: Hendrik PN Scholl, MD, Institute of Molecular and Clinical Ophthalmology Basel (IOB)/University Hospital Basel, Switzerland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT05218928
Other Study ID Numbers:
  • IOB-EyeConic-2021
First Posted:
Feb 1, 2022
Last Update Posted:
Feb 1, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Basel, Switzerland
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 1, 2022