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Age-dependency of Cornea Biomechanics Using OCT Vibrography

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03230981
Enrollment
46
Registered
2017-07-27
Start date
2019-08-01
Completion date
2023-01-01
Last updated
2023-01-19

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

Conditions

Cornea

Keywords

biomechanics, cornea, optical coherence tomography, vibrography, brillouin microscopy

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.

Interventions

DEVICEOptical imaging of the cornea in healthy subjects

OCT vibrography and Brillouin microscopy

Sponsors

Massachusetts Eye and Ear Infirmary
CollaboratorOTHER
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of subjects to successfully complete OCT Vibrography without serious unanticipated adverse events related to application of the device.1 yearFrequency and severity of all treatment-related adverse events

Secondary

MeasureTime frameDescription
Validation of OCT Vibrography data by means of Brillouin microscopy measurements of the in-vivo cornea1 yearUse of Brillouin microscopy in-vivo data for computer simulations to validate OCT Vibrography results.

Countries

United States

Outcome results

None listed

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