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Completed

NCT Number: NCT01775007

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

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.

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Key information

Conditions

Measurement of the Elasticity of the Anterior Eye Segment Corneal Diseases Eye Diseases Presbyopia Refractive Errors

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts Eye and Ear Infirmary, Boston, Massachusetts, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brillouin Ocular Analyser

Device

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

Primary outcomes

  1. 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

  1. Sensitivity and accuracy of Brillouin modulus measurement.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Acronym: Brillouin I

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Jan 24, 2013
Registry last updated
Aug 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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