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Age-dependency of Cornea Biomechanics Using OCT Vibrography

Primary Purpose

Cornea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Optical imaging of the cornea in healthy subjects
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cornea focused on measuring biomechanics, cornea, optical coherence tomography, vibrography, brillouin microscopy

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Healthy subjects

Arm Description

Optical imaging of the cornea in healthy subjects

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Validation of OCT Vibrography data by means of Brillouin microscopy measurements of the in-vivo cornea
Use of Brillouin microscopy in-vivo data for computer simulations to validate OCT Vibrography results.

Full Information

First Posted
July 16, 2017
Last Updated
January 18, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Massachusetts Eye and Ear Infirmary
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1. Study Identification

Unique Protocol Identification Number
NCT03230981
Brief Title
Age-dependency of Cornea Biomechanics Using OCT Vibrography
Official Title
Age-dependency of Cornea Biomechanics Measured by OCT Vibrography: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
January 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Massachusetts Eye and Ear Infirmary

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cornea
Keywords
biomechanics, cornea, optical coherence tomography, vibrography, brillouin microscopy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy subjects
Arm Type
Experimental
Arm Description
Optical imaging of the cornea in healthy subjects
Intervention Type
Device
Intervention Name(s)
Optical imaging of the cornea in healthy subjects
Intervention Description
OCT vibrography and Brillouin microscopy
Primary Outcome Measure Information:
Title
Number of subjects to successfully complete OCT Vibrography without serious unanticipated adverse events related to application of the device.
Description
Frequency and severity of all treatment-related adverse events
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Validation of OCT Vibrography data by means of Brillouin microscopy measurements of the in-vivo cornea
Description
Use of Brillouin microscopy in-vivo data for computer simulations to validate OCT Vibrography results.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seok-Hyun Yun, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12719068
Citation
Wollensak G, Spoerl E, Seiler T. Riboflavin/ultraviolet-a-induced collagen crosslinking for the treatment of keratoconus. Am J Ophthalmol. 2003 May;135(5):620-7. doi: 10.1016/s0002-9394(02)02220-1.
Results Reference
background
PubMed Identifier
18405974
Citation
de Sanctis U, Loiacono C, Richiardi L, Turco D, Mutani B, Grignolo FM. Sensitivity and specificity of posterior corneal elevation measured by Pentacam in discriminating keratoconus/subclinical keratoconus. Ophthalmology. 2008 Sep;115(9):1534-9. doi: 10.1016/j.ophtha.2008.02.020. Epub 2008 Apr 11.
Results Reference
background
PubMed Identifier
15019316
Citation
Li X, Rabinowitz YS, Rasheed K, Yang H. Longitudinal study of the normal eyes in unilateral keratoconus patients. Ophthalmology. 2004 Mar;111(3):440-6. doi: 10.1016/j.ophtha.2003.06.020.
Results Reference
background

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Age-dependency of Cornea Biomechanics Using OCT Vibrography

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