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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01775007
Collaborator
(none)
31
Enrollment
2
Locations
1
Arm
78.1
Actual Duration (Months)
15.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Brillouin Ocular Analyser
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
N/A
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 :
Mar 1, 2011
Actual Primary Completion Date :
Sep 1, 2017
Actual Study Completion Date :
Sep 1, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Number of patients with adverse events [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. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 60 Years
Sexes Eligible for Study:
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:

  • 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

Locations

Site City State Country Postal Code
1 Massachusetts Eye and Ear Infirmary Boston Massachusetts United States 02114
2 Massachusetts General Hospital Boston Massachusetts United States 02114

Sponsors and Collaborators

  • Massachusetts General Hospital

Investigators

  • Principal Investigator: Seok-Hyun Yun, PhD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Seok Hyun Yun, Associate Physicist / Associate Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01775007
Other Study ID Numbers:
  • 2008-P-002176/10
First Posted:
Jan 24, 2013
Last Update Posted:
Aug 2, 2022
Last Verified:
Jul 1, 2022
Keywords provided by Seok Hyun Yun, Associate Physicist / Associate Professor, Massachusetts General Hospital
Lens
Cornea
Presbyopia

Study Results

No Results Posted as of Aug 2, 2022