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

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.

Study Overview

• Status: Recruiting
• Conditions: Keratoconus; Ectasia; Fuchs' Endothelial Dystrophy; Crosslinking
• Intervention / Treatment: Procedure: Brillouin imaging

• Study Type: Observational
• Enrollment (Estimated): 168

Contacts and Locations

• Study Contact: Name: Fatima Clouser, MS; Phone Number: 4077331679; Email: fclouser@mgh.harvard.edu
• Study Contact Backup: Name: Andy Yun, PhD; Email: syun@partners.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: giuliano scarcelli, PhD; Phone Number: 617-768-8698; Email: scarcelli.giuliano@mgh.harvard.edu
      • Sub-Investigator: giuliano scarcelli, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

General population

Description

Inclusion Criteria:

Group I includes healthy subjects with normal appearing corneas, normal topography and pachymetry. Group II includes patients diagnosed as having mild, moderate or advanced keratoconus by our ophthalmology expert on the basis of topography and pachymetry. Group III includes healthy subjects who have undergone LASIK surgery in the past 12 months without complications. Inclusion criteria include normal post-operative topography and pachymetry. Group IV includes patients (age 20 - 60) who have undergone LASIK surgery at least 12 months before the study imaging and have been diagnosed with post-LASIK ectasia based on topography, pachymetry and clinical evaluation.Patients diagnosed with keratoconus. Group V- 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. Group VI-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. Group VII- 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.

Overall Exclusion Criteria for all groups: Volunteers who

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Elastic Modulus of the Cornea	Patients will be measured one time only at their imaging session	2012-2022

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Harvard Medical School (HMS and HSDM)
• Investigators: Principal Investigator: Andy Yun, PhD, Masachusetts General Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2013
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: April 16, 2014
• First Submitted That Met QC Criteria: April 17, 2014
• First Posted (Estimated): April 21, 2014

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: LASIK
• Additional Relevant MeSH Terms: Eye Diseases; Genetic Diseases, Inborn; Pathological Conditions, Anatomical; Eye Diseases, Hereditary; Corneal Diseases; Corneal Dystrophies, Hereditary; Keratoconus; Dilatation, Pathologic; Fuchs' Endothelial Dystrophy
• Other Study ID Numbers: 2012P002178