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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT02118922
Collaborator
Harvard Medical School (HMS and HSDM) (Other)
168
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147
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Brillouin imaging

Study Design

Study Type:
Observational
Anticipated Enrollment :
168 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Actual Study Start Date :
Jun 1, 2013
Anticipated Primary Completion Date :
Sep 1, 2025
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Elastic Modulus of the Cornea [2012-2022]

    Patients will be measured one time only at their imaging session

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Massachusetts General Hospital Boston Massachusetts United States 02114

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Andy Yun, PhD, Masachusetts General Hospital

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Seok Hyun Yun, Associate Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02118922
Other Study ID Numbers:
  • 2012P002178
First Posted:
Apr 21, 2014
Last Update Posted:
Aug 2, 2022
Last Verified:
Jul 1, 2022
Keywords provided by Seok Hyun Yun, Associate Professor, Massachusetts General Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2022