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

Study Overview
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Brief Summary
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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.

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

Conditions
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Keratoconus, Ectasia, Crosslinking, Fuchs' Endothelial Dystrophy

Intervention / Treatment
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* Procedure: Brillouin imaging


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy volunteers<br>Volunteers with normal corneas | Procedure: Brillouin imaging<br> <br> |
| Patients with keratoconus<br>Patients diagnosed with keratoconus | Procedure: Brillouin imaging<br> <br> |
| post-LASIK no complications<br>Subjects who underwent LASIK refractive surgery with no complications | Procedure: Brillouin imaging<br> <br> |
| post-LASIK who developed ectasia<br>patients who underwent LASIK refractive surgery and developed ectasia as a complications | Procedure: Brillouin imaging<br> <br> |
| Volunteers to receive PRK surgery<br>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<br> <br> |
| Volunteers to receive LASIK Surgery<br>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<br> <br> |
| Patients with Fuch's Endothelial Corneal Dystrophy<br>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<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LASIK