Feasibility Tests for Various Prism Configurations for Visual Field Loss

Sponsor

Massachusetts Eye and Ear Infirmary (Other)

Overall Status

Recruiting

CT.gov ID

NCT04424979

Collaborator

National Eye Institute (NEI) (NIH)

Enrollment

Location

Arm

44.8

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators will develop and test different configurations of high-power prisms to expand the field of vision of patients with visual field loss to assist them with obstacle detection when walking. The study will involve multiple visits (typically four) to Schepens Eye Research Institute for fitting and testing with the prism glasses. The overall objective is to determine best designs and fitting parameters for implementation in prism devices for future clinical trials.

Condition or Disease	Intervention/Treatment	Phase
Hemianopia, Homonymous Tunnel Vision Visual Field Defect, Peripheral Visual Field Constriction Bilateral Visual Field Defect Homonymous Bilateral	Device: High power prisms	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

Visual Field Expansion Through Innovative Multi-Periscopic Prism Design

Actual Study Start Date :

Nov 6, 2020

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High power prisms Various configurations of high power prisms will be developed for each individual and custom fit into spectacles lenses.	Device: High power prisms High power prisms designed to shift images from blind areas into portions of the wearer's remaining, seeing, field of vision

Arm

Intervention/Treatment

Experimental: High power prisms

Various configurations of high power prisms will be developed for each individual and custom fit into spectacles lenses.

Device: High power prisms

High power prisms designed to shift images from blind areas into portions of the wearer's remaining, seeing, field of vision

Outcome Measures

Primary Outcome Measures

Field of view expansion [Through study completion, an average of four months]
Horizontal and vertical extent of the expansion (in degrees) of the field of view

Secondary Outcome Measures

Pedestrian detection rate [Through study completion, an average of four months]
Proportion of pedestrians detected (in simulated walking or simulated driving)

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Visual field loss, either peripheral field loss or hemianopic field loss
Visual acuity of at least 20/50 in the better eye
In sufficiently good health to be able to complete sessions lasting 2-4 hours
Able to independently walk short distances
Able to give voluntary, informed consent
Able to speak English

Exclusion Criteria:

Any physical or mental impairments, including cognitive dysfunction, balance problems or other deficits that could impair the ability to walk or use the prism spectacles
A history of seizures in the last 6 months
Hemispatial neglect (subjects with hemianopic field loss only)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Schepens Eye Research Institute	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

Massachusetts Eye and Ear Infirmary
National Eye Institute (NEI)

Investigators

Principal Investigator: Eliezer Peli, MSc, OD, Schepens Eye Research Institute of Massachusetts Eye and Ear

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eli Peli, Senior Scientist, Massachusetts Eye and Ear Infirmary

ClinicalTrials.gov Identifier:

NCT04424979

Other Study ID Numbers:

MPP_Feasibility1
R01EY023385

First Posted:

Jun 11, 2020

Last Update Posted:

Nov 26, 2021

Last Verified:

Nov 1, 2021

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:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Eli Peli, Senior Scientist, Massachusetts Eye and Ear Infirmary

Visual field expansion

Additional relevant MeSH terms:

Hemianopsia

Study Results

No Results Posted as of Nov 26, 2021