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

July 29, 2022 updated by: Seok Hyun Yun, Massachusetts General Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland
        • Institute for Refractive and Ophthalmic Surgery
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts Eye and Ear Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 75 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Normal healthy subjects
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.
Device: Brillouin Ocular Scanner
ACTIVE_COMPARATOR: Keratoconus subjects
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.
Device: Brillouin Ocular Scanner
ACTIVE_COMPARATOR: Subjects diagnosed with PMD
Subjects with Pellucid marginal corneal degeneration (PMD). Multiple axial measurements with the Brillouin Ocular Scanner on the cornea will be carried out.
Device: Brillouin Ocular Scanner
ACTIVE_COMPARATOR: Patients before and after LASK surgery
Healthy subjects who are scheduled to undergo LASIK surgery. Multiple axial measurements with the Brillouin Ocular Scanner on the cornea will be carried out.
Device: Brillouin Ocular Scanner
ACTIVE_COMPARATOR: Patients with keratoconus before and after CXL
Subjects who are scheduled to undergo collagen crosslinking treatment. Multiple axial measurements with the Brillouin Ocular Scanner on the cornea will be carried out.
Device: Brillouin Ocular Scanner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at time of measurement
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
1 day and 4-8 weeks
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
3 days, 1 month, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Massachusetts Eye and Ear Infirmary

Investigators

  • Principal Investigator: Seok Hyun Yun, PhD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2016

Primary Completion (ACTUAL)

September 1, 2019

Study Completion (ACTUAL)

September 1, 2020

Study Registration Dates

First Submitted

June 9, 2017

First Submitted That Met QC Criteria

July 16, 2017

First Posted (ACTUAL)

July 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 2, 2022

Last Update Submitted That Met QC Criteria

July 29, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015P002404

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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