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CompletedNCT01775007Brillouin IUpdated Aug 2, 2022

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

An interventional study of Brillouin Ocular Analyser in Measurement of the Elasticity of the Anterior Eye Segment, sponsored by Massachusetts General Hospital. Completed at 2 sites in United States. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-02.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Device feasibility

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Mar 2011, registered Jan 2013).
Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Not applicable
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

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Conditions studied

  • Measurement of the Elasticity of the Anterior Eye Segment

Keywords

  • Lens
  • Cornea
  • Presbyopia
03

In context

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy volunteers aged 20-60
  • No refractional abnormalities
  • Clear enough cornea and media to permit imaging

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    Normal Healthy Subjects

    Brillouin Ocular Analyser

    Device: Brillouin Ocular Analyser

Interventions

  • DeviceBrillouin Ocular Analyser

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

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

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Study locations

2 sites
  • Massachusetts Eye and Ear Infirmary
    Boston, Massachusetts 02114, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
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References and documents

Publications

  • Scarcelli G, Yun SH. In vivo Brillouin optical microscopy of the human eye. Opt Express. 2012 Apr 9;20(8):9197-202. doi: 10.1364/OE.20.009197. PubMed 22513631 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01775007
Lead sponsor
Massachusetts General Hospital
Responsible party
Seok Hyun Yun (Associate Physicist / Associate Professor, Massachusetts General Hospital) — Principal investigator
First posted
Jan 24, 2013
Start date
Mar 2011
Primary completion
Sep 2017
Completion
Sep 2017
Last update
Aug 2, 2022

Study contacts

Seok-Hyun Yun, PhD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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