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Completed

NCT Number: NCT03230981

Age-dependency of Cornea Biomechanics Using OCT Vibrography

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.

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Optical imaging of the cornea in healthy subjects

Device

OCT vibrography and Brillouin microscopy

Primary outcomes

  1. 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

  1. Validation of OCT Vibrography data by means of Brillouin microscopy measurements of the in-vivo cornea

    Time frame: 1 year

    Use of Brillouin microscopy in-vivo data for computer simulations to validate OCT Vibrography results.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Massachusetts Eye and Ear Infirmary

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 27, 2017
Registry last updated
Jan 19, 2023

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.

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