Feasibility Tests for Various Prism Configurations for Visual Field Loss

NCT ID: NCT04424979

Last Updated: 2025-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-06

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hemianopia, Homonymous Tunnel Vision Visual Field Defect, Peripheral Visual Field Constriction Bilateral Visual Field Defect Homonymous Bilateral

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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High power prisms

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

Group Type EXPERIMENTAL

High power prisms

Intervention Type DEVICE

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

Interventions

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High power prisms

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

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

7 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Eye Institute (NEI)

NIH

Sponsor Role collaborator

Massachusetts Eye and Ear Infirmary

OTHER

Sponsor Role lead

Responsible Party

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Alexandra Bowers

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eliezer Peli, MSc, OD

Role: STUDY_DIRECTOR

Schepens Eye Research Institute of Massachusetts Eye and Ear

Locations

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Schepens Eye Research Institute

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Alex Bowers

Role: CONTACT

617 912 2512

References

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Bowers AR, Manda S, Shekar S, Hwang AD, Jung JH, Peli E. Pilot study of a pedestrian collision detection test for a multisite trial of field expansion devices for hemianopia. Optom Vis Sci. 2024 Jun 1;101(6):408-416. doi: 10.1097/OPX.0000000000002152.

Reference Type DERIVED
PMID: 38990239 (View on PubMed)

Other Identifiers

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R01EY023385

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MPP_Feasibility1

Identifier Type: -

Identifier Source: org_study_id

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