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

NCT ID: NCT01775007

Last Updated: 2022-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2017-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Measurement of the Elasticity of the Anterior Eye Segment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Normal Healthy Subjects

Brillouin Ocular Analyser

Group Type EXPERIMENTAL

Brillouin Ocular Analyser

Intervention Type DEVICE

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

Interventions

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Brillouin Ocular Analyser

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seok Hyun Yun

Associate Physicist / Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seok-Hyun Yun, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 22513631 (View on PubMed)

Other Identifiers

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2008-P-002176/10

Identifier Type: -

Identifier Source: org_study_id

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