A Prospective Trial of the Intelon BOSS(TM) System
Not Applicable
Terminated
- Conditions
- CorneaLens Diseases
- Interventions
- Other: Brillouin Spectroscopy via BOSS System
- Registration Number
- NCT04969406
- Lead Sponsor
- Intelon Optics, Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 23
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Imaging by BOSS System Brillouin Spectroscopy via BOSS System Imaging by the BOSS System
- Primary Outcome Measures
Name Time Method Analysis of variance in corneal and lens measurements to determine repeatability and reproducibility Evaluation Visit (within 30 days of the Screening Visit) A random effect model will be used to assess variation due to device/operator configuration
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Vold Vision plc
🇺🇸Fayetteville, Arkansas, United States