A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia

NCT ID: NCT02118922

Last Updated: 2025-11-06

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

RECRUITING

Total Enrollment

168 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2026-09-30

Brief Summary

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We have developed novel Brillouin microscopy and we are testing its potential for keratoconus and ectasia diagnostics. We plan to perform axial scans of the cornea in human volunteers in order to compare biomechanical properties of Keratoconus vs. Normal corneas and compare biomechanical properties of post-LASIK ectasia vs. normal corneas.

Detailed Description

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Conditions

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Keratoconus Ectasia Crosslinking Fuchs' Endothelial Dystrophy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy volunteers

Volunteers with normal corneas

Brillouin imaging

Intervention Type PROCEDURE

Patients with keratoconus

Patients diagnosed with keratoconus

Brillouin imaging

Intervention Type PROCEDURE

post-LASIK no complications

Subjects who underwent LASIK refractive surgery with no complications

Brillouin imaging

Intervention Type PROCEDURE

post-LASIK who developed ectasia

patients who underwent LASIK refractive surgery and developed ectasia as a complications

Brillouin imaging

Intervention Type PROCEDURE

Volunteers to receive PRK surgery

This group includes patients who have been diagnosed with myopia and have been scheduled to undergo PRK surgery. Patients with high astigmatism \> 2 diopter, prior ocular surgeries, and those patients taking any ocular medications except seasonal allergy medicine such as ketotifen or artificial tears will be excluded.

Brillouin imaging

Intervention Type PROCEDURE

Volunteers to receive LASIK Surgery

This group includes myopic patients who are scheduled to receive LASIK surgery. Patients with high astigmatism \> 2 diopter, prior ocular surgeries, and those patients taking any ocular medications except seasonal allergy medicine such as ketotifen and artificial tears will be excluded.

Brillouin imaging

Intervention Type PROCEDURE

Patients with Fuch's Endothelial Corneal Dystrophy

This group includes subjects who are diagnosed with Fuch's corneal dystrophy, at early, mild and advanced stages. The inclusion also extends to subjects with, and without keratoconus. But this exclude patients with any other corneal disorders other than keratoconus, and/or history of ophthalmological surgeries that may affect endothelium cell status, e.g. cataract surgeries.

Brillouin imaging

Intervention Type PROCEDURE

Interventions

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Brillouin imaging

Intervention Type PROCEDURE

Eligibility Criteria

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Exclusion Criteria

* Have occludable narrow angles (without a patent peripheral iridotomy)
* Monocular subjects
* Do not or cannot understand the instructions for the imaging
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seok Hyun Yun

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andy Yun, PhD

Role: PRINCIPAL_INVESTIGATOR

Masachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Fatima Clouser, MS

Role: CONTACT

4077331679

Andy Yun, PhD

Role: CONTACT

Facility Contacts

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giuliano scarcelli, PhD

Role: primary

617-768-8698

References

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Scarcelli G, Kling S, Quijano E, Pineda R, Marcos S, Yun SH. Brillouin microscopy of collagen crosslinking: noncontact depth-dependent analysis of corneal elastic modulus. Invest Ophthalmol Vis Sci. 2013 Feb 19;54(2):1418-25. doi: 10.1167/iovs.12-11387.

Reference Type BACKGROUND
PMID: 23361513 (View on PubMed)

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 BACKGROUND
PMID: 22513631 (View on PubMed)

Scarcelli G, Pineda R, Yun SH. Brillouin optical microscopy for corneal biomechanics. Invest Ophthalmol Vis Sci. 2012 Jan 20;53(1):185-90. doi: 10.1167/iovs.11-8281.

Reference Type BACKGROUND
PMID: 22159012 (View on PubMed)

Scarcelli G, Yun SH. Confocal Brillouin microscopy for three-dimensional mechanical imaging. Nat Photonics. 2007 Dec 9;2:39-43. doi: 10.1038/nphoton.2007.250.

Reference Type BACKGROUND
PMID: 19812712 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2012P002178

Identifier Type: -

Identifier Source: org_study_id

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