Skip to main content
Clinical Trials/NCT03230981
NCT03230981
Completed
Not Applicable

Age-dependency of Cornea Biomechanics Measured by OCT Vibrography: A Pilot Study

Massachusetts General Hospital1 site in 1 country46 target enrollmentAugust 1, 2019
ConditionsCornea

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cornea
Sponsor
Massachusetts General Hospital
Enrollment
46
Locations
1
Primary Endpoint
Number of subjects to successfully complete OCT Vibrography without serious unanticipated adverse events related to application of the device.
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The aim of this pilot study is to assess the ability of a new optical coherence tomography system to obtain information on biomechanics of the cornea.

Detailed Description

The cornea, the clear front window of the eye, consists of finely intertwined collagen fibers, which give the cornea a microstructure that provides mechanical integrity necessary to maintain its typical dome-shape against the intraocular pressure (IOP). Changes in the biomechanical properties can lead to an abnormal corneal shape and refractive errors. As a result, light is not perfectly focused onto the retina and the vision is affected. A typical example of alterations in the cornea's biomechanical properties is found in patients with an eye disorder called Keratoconus, which leads to progressive thinning of the cornea. Numerous studies have shown that promising interventions like collagen crosslinking (CXL) can slow down an arrest progression of ectatic eye diseases. Keratoconus, as a typical example, although it cannot be cured, could be at least halted by CXL. Therefore, early diagnosis of ectasia is crucial for the patient. Current diagnostic methods of ectasia are based on morphological rather than biomechanical analysis. The irregular patterns of the cornea can be detected by pachymetry and topography before clinical signs occur, but these tests cannot reliably differentiate truly weak or keratoconic corneas from atypical normal ones. These are compelling needs for improved diagnostic methods. More recently, and triggered by those unmet needs, an interest in the mechanical properties of the cornea has emerged. Typical examples of mechanical properties are elastic modulus and corneal stiffness. In this pilot study the investigators will test the ability of a new OCT Vibrography system to determine cornea material parameters. More precisely, the investigators will study the oscillation response in human corneas in-vivo using a stimulus mechanism used to induce vibrations by touching the surface of the cornea. A localized vibration source paired together with phase-sensitive OCT to measure the frequency response function of the human cornea and to analyze the dependency of the frequency response function on age. Additionally the investigators will use Brillouin Microscopy data for computer simulations to validate OCT Vibrography results.

Registry
clinicaltrials.gov
Start Date
August 1, 2019
End Date
January 1, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Seok Hyun Yun

Professor of Dermatology

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • Male or female subjects between the ages of 18 to 79 years
  • Healthy normal subjects with no significant eye disease and no significant refractive errors

Exclusion Criteria

  • Volunteers with implanted intraocular lenses
  • Volunteers with LASIK or any other eye surgery, and monocular volunteers
  • Volunteers with restricted mobility, who cannot stand up, walk or sit still on a chair without a back
  • Subjects who do not or cannot understand the instructions for imaging
  • Subjects with diabetes, glaucoma family history
  • Subjects who are pregnant and/or breastfeeding.

Outcomes

Primary Outcomes

Number of subjects to successfully complete OCT Vibrography without serious unanticipated adverse events related to application of the device.

Time Frame: 1 year

Frequency and severity of all treatment-related adverse events

Secondary Outcomes

  • Validation of OCT Vibrography data by means of Brillouin microscopy measurements of the in-vivo cornea(1 year)

Study Sites (1)

Loading locations...

Similar Trials