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NCT04969406 Clinical Trial

A Prospective Trial of the Intelon BOSS(TM) System

Cornea Clinical Trial

Official title:
A Prospective Trial Designed to Evaluate the Repeatability and Reproducibility of the Intelon BOSS(TM) System

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04969406
Other study ID # P21-02
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date July 24, 2021
Est. completion date December 10, 2021

Study information
Verified date March 2022
Source Intelon Optics, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 23
Est. completion date December 10, 2021
Est. primary completion date December 10, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age 18 years or older 2. Availability, willingness and sufficient cognitive awareness to comply with the examination procedures and schedule 3. Signed Written Informed Consent Exclusion Criteria: 1. No light perception or low vision rendering the subject unable to fixate to keep gaze still enough to acquire images 2. Presence of corneal opacity 3. Presence of cortical cataracts visible in an undilated pupil 4. Any systemic disease or disorder which would prohibit image acquisition (e.g., Parkinson's Disease).

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Brillouin Spectroscopy via BOSS System
Biomechanical Imaging of the Cornea and Lens

Locations
Country Name City State
United States Vold Vision plc Fayetteville Arkansas

Sponsors (1)
Lead Sponsor Collaborator
Intelon Optics, Inc

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Evaluation Visit (within 30 days of the Screening Visit)
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