Multiplexing Prism Fitting for Field Expansion of Monocular Vision

Sponsor

Massachusetts Eye and Ear Infirmary (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06027216

Collaborator

National Eye Institute (NEI) (NIH)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The investigators are developing an assistive device, known as multiplexing prism that expands the field of view for individuals with acquired monocular vision (loss of an eye). The investigators are testing a simplified design and fitting protocol to provide field expansion for individuals with acquired monocular vision.

Condition or Disease	Intervention/Treatment	Phase
One Eye Blindness Blind Left Eye Blind Right Eye	Device: Multiplexing Prism	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Individuals with Acquired Monocular Vision/ Blindness in One EyeIndividuals with Acquired Monocular Vision/ Blindness in One Eye

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

Monocular Visual Confusion for Field Expansion

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jul 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Field Expansion Field of view on the nasal side (same side as the blind eye) with and without multiplexing prism	Device: Multiplexing Prism Multiplexing prism is designed for spatial vision multiplexing. It allows partial light transmission through the prism allow the observer to simultaneously see the physical world through the prism and see the "shifted view" from the non-seeing side. It is developed to expand the field of view of individuals with just one eye.

Arm

Intervention/Treatment

Experimental: Field Expansion

Field of view on the nasal side (same side as the blind eye) with and without multiplexing prism

Device: Multiplexing Prism

Multiplexing prism is designed for spatial vision multiplexing. It allows partial light transmission through the prism allow the observer to simultaneously see the physical world through the prism and see the "shifted view" from the non-seeing side. It is developed to expand the field of view of individuals with just one eye.

Outcome Measures

Primary Outcome Measures

Field expansion from multiplexing prism [Approximately 2 sessions, up to 3 hours for each session, any time within 2 month period]
Field expansion based on the maximum field of view on the nasal side (same side as the blind eye) with and without multiplexing prism. If the nasal field with multiplexing prism is larger than without prism, there is a gain in field expansion.

Secondary Outcome Measures

Maximum extent of nasal visual field with multiplexing prism [Approximately 2 sessions, up to 3 hours for each session, any time within 2 month period]
The farthest nasal field of view with multiplexing prism

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

No medical health issues such as seizures, motor movements problem
Loss of vision in one eye (no light perception/enucleation/evisceration) for >1 year
Visual acuity of the seeing eye: Better than 20/32 visual acuity with correction
No visual field defect in the seeing eye (nasal field of at least >45degree)
No medical health issues such as seizures, motor movements problem

Exclusion Criteria:

Patients with any physical or mental disabilities, including cognitive dysfunction, balance problems, or other deficits that could impair their ability to respond to the stimuli presented in this study will be excluded
Any person with motor movements problem (e.g., unable to use extremities)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Massachusetts Eye and Ear Infirmary
National Eye Institute (NEI)

Investigators

Principal Investigator: Jaehyun Jung, Ph.D., Schepens Eye Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Jaehyun Jung, Assistant Scientist, Massachusetts Eye and Ear Infirmary

ClinicalTrials.gov Identifier:

NCT06027216

Other Study ID Numbers:

2023P001878
R01EY031777

First Posted:

Sep 7, 2023

Last Update Posted:

Sep 7, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jaehyun Jung, Assistant Scientist, Massachusetts Eye and Ear Infirmary

Additional relevant MeSH terms:

Blindness

Study Results

No Results Posted as of Sep 7, 2023