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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Seok Hyun Yun, Massachusetts General Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01775007
First Posted: January 24, 2013
Last Update Posted: January 24, 2013
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.
Information provided by (Responsible Party):
Seok Hyun Yun, Massachusetts General Hospital
  Purpose
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 Intervention Phase
Measurement of the Elasticity of the Anterior Eye Segment Device: Brillouin Ocular Analyser Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study to Test the Safety and Feasibility of a Brillouin Ocular Analyzer

Resource links provided by NLM:


Further study details as provided by Seok Hyun Yun, Massachusetts General Hospital:

Primary Outcome Measures:
  • 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:
  • 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.


Estimated Enrollment: 10
Study Start Date: March 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Normal Healthy Subjects
Brillouin Ocular Analyser
Device: Brillouin Ocular Analyser
Measurement of the local viscoelastic properties (Brillouin Shift) of the Anterior Eye Segment.

  Eligibility

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
  Contacts and Locations
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


Contacts
Contact: Natalia Perrotta 617-768-8705 nperrotta@partners.org
Contact: Sebastien Besner, PhD 617-724-6798 sbesner@partners.org

Locations
United States, Massachusetts
Massachusetts Eye and Ear Infirmary Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Roberto Pineda, MD         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Natalia Perrotta    617-768-8705    nperrotta@partners.org   
Sub-Investigator: Sebastien Besner, PhD         
Sub-Investigator: Giuliano Scarcelli, PhD         
Principal Investigator: Seok H Yun, PhD         
Sub-Investigator: Mehron Puoris'haag, M.D.         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Seok H Yun, PhD Massachusetts General Hospital
  More Information

Publications:
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 Submitted: January 22, 2013
First Posted: January 24, 2013
Last Update Posted: January 24, 2013
Last Verified: January 2013

Keywords provided by Seok Hyun Yun, Massachusetts General Hospital:
Lens
Cornea
Stiffness
Brillouin Shift
Young Modulus