Cornea, Lens Diseases
Conditions
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.
Interventions
OTHERBrillouin Spectroscopy via BOSS System
Biomechanical Imaging of the Cornea and Lens
Sponsors
Intelon Optics, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed