A Study to Test the Potential of Brillouin Microscopy for Biomechanical Properties Measurements in Human Cornea

Mass General Brigham

Status: Completed

Conditions: Keratoconus; Pellucid Marginal Corneal Degeneration; Keratectasia

Treatments: Device: Brillouin Ocular Scanner

Study type: Interventional

Funder types: Other

Identifiers

NCT03220529

2015P002404

Details and patient eligibility

About

The purpose of this research study is to find out if the new Brillouin Ocular Scanner can measure the variation (difference) of the corneal elastic changes involved in the onset of corneal ectasia, induced by LASIK surgery and cornea collagen crosslinking (CXL) treatment. Ectasia refers to the thinning and bulging of the cornea and results in severe vision degradation (loss), which may occur because of a progressive disease (keratoconus) or because of LASIK surgery. It is believed that the structural weakening of the cornea plays a major role in developing ectasia. CXL is a treatment that is able to halt the progression of ectasia.

The Brillouin Ocular Scanner is a technique based on the principles used in the laser speed measuring of a car (radar gun). When laser light illuminates a moving sample, a portion of the light slightly changes color. In our body, e.g in eye and corneal tissue, very weak sound waves are naturally present and they can induce a similar color shift. Measuring this color shift with a sensitive light color meter (spectrometer), we will measure the sound speed in the tissue.

Enrollment: 85 patients

Sex: All

Ages: 15 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects with healthy cornea
• Patients with mild, moderate, or advanced keratoconus
• Subjects diagnosed with PMD
• Patients before and after LASK surgery
• Patients with keratoconus before and after collagen crosslinking treatment

Exclusion criteria

• Normal volunteer group: presbyopia and/or cataract
• Keratoconus subjects group: corneas with scars developed, received any ocular surgery, such as laser vision correction surgeries or CXL treatment
• Subjects diagnosed with PMD: excludes corneas received any ocular surgery, such as laser vision correction or CXL treatment
• Patients before and after LASK surgery Corneas received priori ocular surgeries, taking any ocular medications except season allergy medicine such as artificial tears

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 5 patient groups

Normal healthy subjects

Active Comparator group

Description:

Healthy subjects with normal appearing corneas respecting all the general inclusion/exclusion criteria. Multiple axial measurements with the Brillouin Ocular Scanner on the cornea will be carried out.

Treatment:

Device: Brillouin Ocular Scanner

Keratoconus subjects

Active Comparator group

Description:

Subjects classified as patients with mild, moderate, or advanced keratoconus. Multiple axial measurements with the Brillouin Ocular Scanner on the cornea will be carried out.

Treatment:

Device: Brillouin Ocular Scanner

Subjects diagnosed with PMD

Active Comparator group

Description:

Subjects with Pellucid marginal corneal degeneration (PMD). Multiple axial measurements with the Brillouin Ocular Scanner on the cornea will be carried out.

Treatment:

Device: Brillouin Ocular Scanner

Patients before and after LASK surgery

Active Comparator group

Description:

Healthy subjects who are scheduled to undergo LASIK surgery. Multiple axial measurements with the Brillouin Ocular Scanner on the cornea will be carried out.

Treatment:

Device: Brillouin Ocular Scanner

Patients with keratoconus before and after CXL

Active Comparator group

Description:

Subjects who are scheduled to undergo collagen crosslinking treatment. Multiple axial measurements with the Brillouin Ocular Scanner on the cornea will be carried out.

Treatment:

Device: Brillouin Ocular Scanner