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

Not Applicable

Completed

• Conditions: Measurement of the Elasticity of the Anterior Eye Segment
• Interventions: Device: Brillouin Ocular Analyser

• Registration Number: NCT01775007
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2013-01-22
• Study First Submitted QC: 2013-01-22
• Study First Posted: 2013-01-24
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-29
• Last Update Posted: 2022-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Normal Healthy Subjects	Brillouin Ocular Analyser	Brillouin Ocular Analyser

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Massachusetts Eye and Ear Infirmary; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States