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

NCT02118922 | Recruiting

• 1 other identifier: 2012P002178
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Keratoconus; Ectasia; Crosslinking; Fuchs' Endothelial Dystrophy

Keywords

LASIK

Outcome Measures

Primary Outcomes (1)

• Elastic Modulus of the Cornea

  Patients will be measured one time only at their imaging session

  2012-2022

Study Arms (7)

Healthy volunteers

Volunteers with normal corneas

Procedure: Brillouin imaging

Patients with keratoconus

Patients diagnosed with keratoconus

Procedure: Brillouin imaging

post-LASIK no complications

Subjects who underwent LASIK refractive surgery with no complications

Procedure: Brillouin imaging

post-LASIK who developed ectasia

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

Procedure: Brillouin imaging

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.

Procedure: Brillouin imaging

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.

Procedure: Brillouin imaging

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.

Procedure: Brillouin imaging

Interventions

Brillouin imaging PROCEDURE

Healthy volunteers; Patients with Fuch's Endothelial Corneal Dystrophy; Patients with keratoconus; Volunteers to receive LASIK Surgery; Volunteers to receive PRK surgery; post-LASIK no complications; post-LASIK who developed ectasia

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General population

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Harvard Medical School (HMS and HSDM): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 23361513 BACKGROUND

• 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.

  PMID: 22513631 BACKGROUND

• 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.

  PMID: 22159012 BACKGROUND

• 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.

  PMID: 19812712 BACKGROUND

MeSH Terms

Conditions

Keratoconus; Dilatation, Pathologic; Fuchs' Endothelial Dystrophy

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Corneal Dystrophies, Hereditary; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Andy Yun, PhD

  Masachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatima Clouser, MS

CONTACT

4077331679; fclouser@mgh.harvard.edu

Andy Yun, PhD

CONTACT

syun@partners.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: April 21, 2014
• Study Start: June 1, 2013
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 6, 2025

Record last verified: 2025-11

Locations

US (1)