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

Enrollment

Locations

Anticipated Duration (Months)

111.1

Patients Per Site

6.5

Patients Per Site Per Month

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
Retinal Dystrophies	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)

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

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