A Pilot Study to Test the Safety and Feasibility of a Brillouin Ocular Analyzer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Measurement of the Elasticity of the Anterior Eye Segment
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 31
- Locations
- 2
- Primary Endpoint
- Number of patients with adverse events
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
A Brillouin ocular analyzer uses a low-power near infrared laser light to probe the viscoelastic properties of the cornea and crystalline lens in the eye. The study hypothesis is that the instrument can measure the Brillouin light scattering spectra from the eye safely and effectively from human subjects.
Investigators
Seok Hyun Yun
Associate Physicist / Associate Professor
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •Healthy volunteers aged 20-60
- •No refractional abnormalities
- •Clear enough cornea and media to permit imaging
Exclusion Criteria
- •Occludable narrow angles (without a patent peripheral iridotomy)
- •Other ocular or systemic pathology, which precludes safe eye dilation
- •LASIK eye surgery
- •Allergies to the dilation medication
- •Only one healthy eye
- •Pregnant women or expected pregnancy within the timeframe of the study
- •Do not or cannot understand the instructions for the imaging
- •Restricted mobility
Outcomes
Primary Outcomes
Number of patients with adverse events
Time Frame: 6 months
Complete standard eye exam including medical and ocular history with manifest refraction, Amsler grid evaluation (macular test), color vision (Ishihara color plates), Scotopic pupil measurement (Colvard pupillometer), Slit lamp biomicroscopy of anterior segment, intraocular pressure measurement, dilated fundoscopic exam (2.5% phenylephrine and 0.5% tropicamide), and corneal topography (Pentacam).
Secondary Outcomes
- Sensitivity and accuracy of Brillouin modulus measurement.(at time of imaging session)