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

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.

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Key information

Conditions

Pellucid Marginal Corneal Degeneration Corneal Diseases Eye Diseases Keratectasia Keratoconus

Age range

15 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Refractive and Ophthalmic Surgery, Zurich, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brillouin Ocular Scanner

Device

Primary outcomes

Brillouin frequency shift of corneal stroma

Time frame: at time of measurement

Brillouin frequency shift of corneal stroma in normal corneas and corneas diagnosed with keratoconus and pellucid marginal degeneration
Change of Brillouin frequency shift from base line in corneas received LASIK surgery

Time frame: 1 day and 4-8 weeks

Brillouin frequency shift in corneas before and after receiving LASIK surgery
Change of Brillouin frequency shift from base line in corneas received crosslinking treatment

Time frame: 3 days, 1 month, 3 months, 6 months

Brillouin frequency shift in corneas before and after receiving crosslinking surgery

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

Massachusetts Eye and Ear Infirmary

Registry information

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2020
First posted: Jul 18, 2017
Registry last updated: Aug 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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