A Pilot Study to Test the Safety and Feasibility of a Brillouin Ocular Analyzer

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Study to Test the Safety and Feasibility of a Brillouin Ocular Analyzer

Conditions
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Measurement of the Elasticity of the Anterior Eye Segment

Intervention / Treatment
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* Device: Brillouin Ocular Analyser


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal Healthy Subjects<br>Brillouin Ocular Analyser | Device: Brillouin Ocular Analyser<br>* Measurement of the local viscoelastic properties (Brillouin Shift) of the Anterior Eye Segment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events | 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). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and accuracy of Brillouin modulus measurement. | It will be tested if, with the parameters designed for in vivo operation, the Brillouin ocular analyzer is sensitive enough to characterize the elasticity of cornea and crystalline lens as well as its spatial distribution within the ocular tissue. | at time of imaging session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lens, Cornea, Presbyopia