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

Mass General Brigham

Status: Enrolling

Conditions: Ectasia; Keratoconus; Fuchs' Endothelial Dystrophy; Crosslinking

Treatments: Procedure: Brillouin imaging

Study type: Observational

Funder types: Other

Identifiers

NCT02118922

2012P002178

Details and patient eligibility

About

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.

Enrollment: 168 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

168 participants in 7 patient groups

Healthy volunteers

Description:

Volunteers with normal corneas

Treatment:

Procedure: Brillouin imaging

Patients with keratoconus

Description:

Patients diagnosed with keratoconus

Treatment:

Procedure: Brillouin imaging

post-LASIK no complications

Description:

Subjects who underwent LASIK refractive surgery with no complications

Treatment:

Procedure: Brillouin imaging

post-LASIK who developed ectasia

Description:

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

Treatment:

Procedure: Brillouin imaging

Volunteers to receive PRK surgery

Description:

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.

Treatment:

Procedure: Brillouin imaging

Volunteers to receive LASIK Surgery

Description:

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.

Treatment:

Procedure: Brillouin imaging

Patients with Fuch's Endothelial Corneal Dystrophy

Description:

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.

Treatment:

Procedure: Brillouin imaging