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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Seok Hyun Yun, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01775007
First received: January 22, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  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
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Pilot Study to Test the Safety and Feasibility of a Brillouin Ocular Analyzer

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Number of patients with adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: January 22, 2013
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Lens
Cornea
Stiffness
Brillouin Shift
Young Modulus

ClinicalTrials.gov processed this record on November 24, 2014