Purpose

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

Eligibility

Eligible Ages
Between 20 Years and 75 Years
Eligible Genders
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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross-Sectional

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
giuliano scarcelli, PhD
617-768-8698
scarcelli.giuliano@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Fatima Clouser, MS
4077331679
fclouser@mgh.harvard.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.