Back to resultsA Prospective Trial of the Intelon BOSS(TM) System
Primary Purpose
Cornea, Lens Diseases
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brillouin Spectroscopy via BOSS System
Sponsored by
About this trial
This is an interventional other trial for Cornea
Eligibility Criteria
Inclusion Criteria:
- Age 18 years or older
- Availability, willingness and sufficient cognitive awareness to comply with the examination procedures and schedule
- Signed Written Informed Consent
Exclusion Criteria:
- No light perception or low vision rendering the subject unable to fixate to keep gaze still enough to acquire images
- Presence of corneal opacity
- Presence of cortical cataracts visible in an undilated pupil
- Any systemic disease or disorder which would prohibit image acquisition (e.g., Parkinson's Disease).
Sites / Locations
- Vold Vision plc
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Imaging by BOSS System
Arm Description
Imaging by the BOSS System
Outcomes
Primary Outcome Measures
Analysis of variance in corneal and lens measurements to determine repeatability and reproducibility
A random effect model will be used to assess variation due to device/operator configuration
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04969406
Brief Title
A Prospective Trial of the Intelon BOSS(TM) System
Official Title
A Prospective Trial Designed to Evaluate the Repeatability and Reproducibility of the Intelon BOSS(TM) System
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Enrollment Difficulty
Study Start Date
July 24, 2021 (Actual)
Primary Completion Date
December 10, 2021 (Actual)
Study Completion Date
December 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intelon Optics, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A prospective, open-label, single-site clinical trial designed to evaluate the repeatability and reproducibility of biomechanical imaging by the BOSS device. Subjects will undergo unilateral biomechanical mapping of the cornea and lens by three BOSS devices operated by three (3) different operators.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cornea, Lens Diseases
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Imaging by BOSS System
Arm Type
Experimental
Arm Description
Imaging by the BOSS System
Intervention Type
Other
Intervention Name(s)
Brillouin Spectroscopy via BOSS System
Intervention Description
Biomechanical Imaging of the Cornea and Lens
Primary Outcome Measure Information:
Title
Analysis of variance in corneal and lens measurements to determine repeatability and reproducibility
Description
A random effect model will be used to assess variation due to device/operator configuration
Time Frame
Evaluation Visit (within 30 days of the Screening Visit)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18 years or older
Availability, willingness and sufficient cognitive awareness to comply with the examination procedures and schedule
Signed Written Informed Consent
Exclusion Criteria:
No light perception or low vision rendering the subject unable to fixate to keep gaze still enough to acquire images
Presence of corneal opacity
Presence of cortical cataracts visible in an undilated pupil
Any systemic disease or disorder which would prohibit image acquisition (e.g., Parkinson's Disease).
Facility Information:
Facility Name
Vold Vision plc
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72704
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Prospective Trial of the Intelon BOSS(TM) System
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