Object Finder for a Retinal Prosthesis

Retinitis Pigmentosa Clinical Trial

Official title:

Object Finder for a Retinal Prosthesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04319809
• Other study ID #: MHS-OF01
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: August 31, 2022

Study information

• Verified date: September 2022
• Source: Minnesota HealthSolutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed project seeks to provide object recognition as a feature in a retinal implant system. Participants will be able to direct an object recognition application to find a desired object in the field of view of the head-mounted camera, and to direct the participant's view towards it through the presentation of a recognizable icon. A prototype system will be developed and evaluated in human subjects in phase I. A full system implementation and a second phase of the trial will be completed in phase II.

Description:

The investigators propose to add an object-finding feature to a retinal prosthesis system. To use this feature, the participant will enable a special mode and input the desired object from a set of pre-programmed object types. Imagery from the visible light camera in the system eyeglasses will be processed using object recognition software as the participant scans their head across the room scene. When the object is identified in the scene by the processor, a flashing icon will be output to the epiretinal array in the appropriate position to guide the participant to the physical location of the object. Once located, the system will track the location of the object.

There will be two phases to the human subjects evaluation, each run initially through simulations in sighted human subjects, followed by tests in Argus II participants. In phase 1, system evaluation in human subjects at Johns Hopkins UNiversity (JHU) will explore performance in representative tasks and compare prosthetic visual performance without and with the new object finding feature. An important aspect of the evaluation will be the comparison of different icons and presentation modes to assist participants in locating and reaching objects. In phase 2, the system will be integrated into the Argus II video processing unit (VPU), and JHU will conduct human trials that include functional testing of the integrated prototype in representative environments and optimizing the ergonomics of the system, e.g. simultaneous finding and tracking of multiple objects/icons.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• For healthy volunteers: Vision corrected to 20/25, good general health

• For retinitis pigmentosa (RP) patients: End-stage retinitis pigmentosa, recipient of an Argus II retinal prosthesis system

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Retinitis
• Retinitis Pigmentosa

Intervention

Device:
• Object recognition subsystem
The object recognition subsystem is an add-on to the Argus II retinal prosthesis system. in the early stage of the study the subsystem will run on a separate processor; in the later stage the subsystem will run in the Argus II user's video processing unit.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Minnesota HealthSolutions	Johns Hopkins University, Second Sight Medical Products

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance (% correct)	This outcome measure will compare task completion without and with use of the subsystem	Year 1 (prototype)
Primary	Performance (% correct)	This outcome measure will compare task completion without and with use of the subsystem	Year 3 (pre-production unit)
Primary	Time to completion	This outcome measure will compare task completion without and with use of the subsystem	Year 1 (prototype)
Primary	Time to completion	This outcome measure will compare task completion without and with use of the subsystem	Year 3 (pre-production unit)