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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01775007

Acronym

Brillouin I

Enrollment

Registered

2013-01-24

Start date

2011-03-31

Completion date

2017-09-30

Last updated

2022-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Measurement of the Elasticity of the Anterior Eye Segment

Keywords

Lens, Cornea, Presbyopia

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.

Interventions

DEVICEBrillouin Ocular Analyser

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Number of patients with adverse events	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

Measure	Time frame	Description
Sensitivity and accuracy of Brillouin modulus measurement.	at time of imaging session	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026