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

Massachusetts General Hospital31 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Measurement of the Elasticity of the Anterior Eye Segment

Interventions

Brillouin Ocular AnalyserDEVICE

Measurement of the local viscoelastic properties (Brillouin Shift) of the Anterior Eye Segment.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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).

Time frame: 6 months

Secondary Outcomes

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.

Time frame: at time of imaging session

Data from ClinicalTrials.gov

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