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

Massachusetts General Hospital1 site in 1 country168 target enrollmentJune 1, 2013

ConditionsKeratoconus Ectasia Crosslinking Fuchs' Endothelial Dystrophy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Keratoconus
Sponsor: Massachusetts General Hospital
Enrollment: 168
Locations: 1
Primary Endpoint: Elastic Modulus of the Cornea
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 1, 2013

End Date

September 1, 2026

Last Updated

5 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Massachusetts General Hospital

Responsible Party

Principal Investigator

Seok Hyun Yun

Associate Professor

Massachusetts General Hospital

Eligibility Criteria

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