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Clinical Trials/NCT03220529
NCT03220529
Completed
Not Applicable

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

Massachusetts General Hospital2 sites in 2 countries85 target enrollmentNovember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pellucid Marginal Corneal Degeneration
Sponsor
Massachusetts General Hospital
Enrollment
85
Locations
2
Primary Endpoint
Brillouin frequency shift of corneal stroma
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
September 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Seok Hyun Yun

Professor

Massachusetts General Hospital

Eligibility Criteria

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

Outcomes

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 crosslinking treatment

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

Brillouin frequency shift in corneas before and after receiving crosslinking surgery

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

Study Sites (2)

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