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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01775007
Recruitment Status : Completed
First Posted : January 24, 2013
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Seok Hyun Yun, 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.

Condition or disease Intervention/treatment Phase
Measurement of the Elasticity of the Anterior Eye Segment Device: Brillouin Ocular Analyser Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: A Pilot Study to Test the Safety and Feasibility of a Brillouin Ocular Analyzer
Actual Study Start Date : March 2011
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Arm Intervention/treatment
Experimental: Normal Healthy Subjects
Brillouin Ocular Analyser
Device: Brillouin Ocular Analyser
Measurement of the local viscoelastic properties (Brillouin Shift) of the Anterior Eye Segment.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01775007


Locations
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United States, Massachusetts
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Seok-Hyun Yun, PhD Massachusetts General Hospital

Publications of Results:
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Responsible Party: Seok Hyun Yun, Associate Physicist / Associate Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01775007     History of Changes
Other Study ID Numbers: 2008-P-002176/10
First Posted: January 24, 2013    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019

Keywords provided by Seok Hyun Yun, Massachusetts General Hospital:
Lens
Cornea
Presbyopia