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Feasibility Tests for Various Prism Configurations for Visual Field Loss

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High power prisms
Sponsored by
Massachusetts Eye and Ear Infirmary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Hemianopia, Homonymous focused on measuring Visual field expansion, Prisms, Hemianopsia, Tunnel vision, Visual field loss

Eligibility Criteria

7 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Schepens Eye Research InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

High power prisms

Arm Description

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

Outcomes

Primary Outcome Measures

Field of view expansion
Horizontal and vertical extent of the expansion (in degrees) of the field of view

Secondary Outcome Measures

Pedestrian detection rate
Proportion of pedestrians detected (in simulated walking or simulated driving)

Full Information

First Posted
June 5, 2020
Last Updated
January 6, 2023
Sponsor
Massachusetts Eye and Ear Infirmary
Collaborators
National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT04424979
Brief Title
Feasibility Tests for Various Prism Configurations for Visual Field Loss
Official Title
Visual Field Expansion Through Innovative Multi-Periscopic Prism Design
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 6, 2020 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts Eye and Ear Infirmary
Collaborators
National Eye Institute (NEI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemianopia, Homonymous, Tunnel Vision, Visual Field Defect, Peripheral, Visual Field Constriction Bilateral, Visual Field Defect Homonymous Bilateral
Keywords
Visual field expansion, Prisms, Hemianopsia, Tunnel vision, Visual field loss

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High power prisms
Arm Type
Experimental
Arm Description
Various configurations of high power prisms will be developed for each individual and custom fit into spectacles lenses.
Intervention Type
Device
Intervention Name(s)
High power prisms
Intervention Description
High power prisms designed to shift images from blind areas into portions of the wearer's remaining, seeing, field of vision
Primary Outcome Measure Information:
Title
Field of view expansion
Description
Horizontal and vertical extent of the expansion (in degrees) of the field of view
Time Frame
Through study completion, an average of four months
Secondary Outcome Measure Information:
Title
Pedestrian detection rate
Description
Proportion of pedestrians detected (in simulated walking or simulated driving)
Time Frame
Through study completion, an average of four months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sailaja Manda
Phone
617 912 2522
Email
sailaja_manda@meei.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alex Bowers, PhD
Phone
617 912 2512
Email
alex_bowers@meei.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eliezer Peli, MSc, OD
Organizational Affiliation
Schepens Eye Research Institute of Massachusetts Eye and Ear
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schepens Eye Research Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Feasibility Tests for Various Prism Configurations for Visual Field Loss

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