- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04424979
Feasibility Tests for Various Prism Configurations for Visual Field Loss
March 11, 2024 updated by: Eli Peli, Massachusetts Eye and Ear Infirmary
Visual Field Expansion Through Innovative Multi-Periscopic Prism Design
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sailaja Manda
- Phone Number: 617 912 2522
- Email: sailaja_manda@meei.harvard.edu
Study Contact Backup
- Name: Alex Bowers, PhD
- Phone Number: 617 912 2512
- Email: alex_bowers@meei.harvard.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Recruiting
- Schepens Eye Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
High power prisms designed to shift images from blind areas into portions of the wearer's remaining, seeing, field of vision
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Field of view expansion
Time Frame: Through study completion, an average of four months
|
Horizontal and vertical extent of the expansion (in degrees) of the field of view
|
Through study completion, an average of four months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pedestrian detection rate
Time Frame: Through study completion, an average of four months
|
Proportion of pedestrians detected (in simulated walking or simulated driving)
|
Through study completion, an average of four months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Eliezer Peli, MSc, OD, Schepens Eye Research Institute of Massachusetts Eye and Ear
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 6, 2020
Primary Completion (Estimated)
August 1, 2024
Study Completion (Estimated)
August 1, 2024
Study Registration Dates
First Submitted
June 5, 2020
First Submitted That Met QC Criteria
June 8, 2020
First Posted (Actual)
June 11, 2020
Study Record Updates
Last Update Posted (Actual)
March 13, 2024
Last Update Submitted That Met QC Criteria
March 11, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MPP_Feasibility1
- R01EY023385 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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