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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03220529
Enrollment
85
Registered
2017-07-18
Start date
2016-11-30
Completion date
2020-09-30
Last updated
2022-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratectasia, Keratoconus, Pellucid Marginal Corneal Degeneration

Brief summary

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.

Interventions

DEVICEBrillouin Ocular Scanner

Sponsors

Massachusetts Eye and Ear Infirmary
CollaboratorOTHER
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Brillouin frequency shift of corneal stromaat time of measurementBrillouin 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 surgery1 day and 4-8 weeksBrillouin frequency shift in corneas before and after receiving LASIK surgery
Change of Brillouin frequency shift from base line in corneas received crosslinking treatment3 days, 1 month, 3 months, 6 monthsBrillouin frequency shift in corneas before and after receiving crosslinking surgery

Countries

Switzerland, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026