Back to resultsCorneal Biomechanics Study
Primary Purpose
Myopia
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inversion
Sponsored by
About this trial
This is an interventional basic science trial for Myopia
Eligibility Criteria
Inclusion Criteria
A person is eligible for inclusion in the study if he/she:
- Is an adult between the ages of 18 and 55.
- Is under 250 pounds.
Exclusion Criteria
A person will be excluded from the study if he/she:
- Is under the age of 18 or over the age of 55 yrs.
- Weighs more than 250 pounds.
- Has clinically significant dry eye.
- Has glaucoma.
- Has hypertension.
- Has prior CVA.
- Has cardiovascular disease.
- Has lower extremity joint injury, damage, or replacement.
- Has baseline bradycardia.
- Has any orthopaedic injuries.
- Is pregnant.
- Has hiatal and ventral hernias.
- Has vertigo.
- Has acid reflux (GERD).
- Is undergoing myopia control treatment (e.g. atropinisation, Ortho-K, bifocal contact lenses etc.).
- Has conditions or has undergone procedures resulting in significant corneal irregularity (e.g. keratoconus, corneal transplant, etc.). This does not include astigmatism and basic refractive errors.
- Has any ocular or systemic diseases that, in the opinion of the PI/SI, would interfere with obtaining a measurement.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Subjects will undergo 4-5 visits total over the course of 6 months. There will be 3-4 visits that will be done at the Flaum Eye Institute. During these sessions the subject will be measured with a stationary topographer (GALILEI G4), with a rotatable topography measurement (Oculus Topographer) and a Tonometer. The subject's heart rate and blood pressure will also be measured (using a commercially available blood pressure and heart rate meter). The GALILEI measurement will only be done once. The rest of the measurements will be done up to 4 times. Once at the start of the study session then, after the subject has been inverted using a commercially available inversion table to first 135 degrees, then 150 degrees and finally to 165 degrees. The blood pressure and heart rate will be monitored to ensure subject safety. There will also be one visit at the Massachusetts General Hospital. The visit will be 2 hours and will involve a Brillouin Microscopy measurement.
Outcomes
Primary Outcome Measures
Corneal Surface Topography Measurement
Corneal Surface Topography measurement will be collected at each of the 3-4 study visits at the Flaum Eye Institute. The numerical data generated will be analyzed and compared within each subject as well as across subjects.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03658239
Brief Title
Corneal Biomechanics Study
Official Title
The Investigation of Corneal Biomechanics Through the Changes in the Intraocular Pressure
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Organizational Issues.
Study Start Date
December 2018 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
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 goal of the study is to investigate relationship between the corneal response to a temporary increase in intraocular pressure and corneal mechanical properties.
Detailed Description
The preliminary theoretical study in which the corneal geometry at different intraocular pressure (IOP) levels is investigated using a theoretical biomechanical cornea model found changes in both conventional refractive error (sphere and cylinder) and irregular astigmatism i.e. higher order aberrations (e.g. spherical aberration, trefoil and quadrafoil). This is due to the mechanical characteristics of the cornea determined largely by interaction between collagen fibrils organization and extrafibrillar matrix material properties. Corneal geometry and the material properties are the two main factors that contribute to the changes in corneal aberrations with IOP elevation. These aberration changes due to the variation of IOP and the material properties of the cornea can be measured routinely with corneal topography systems (UR) and Brillouin ocular scanner (MGH), respectively and can guide the investigators to study their impact on optical and biomechanical behaviors of the cornea.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
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
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Subjects will undergo 4-5 visits total over the course of 6 months. There will be 3-4 visits that will be done at the Flaum Eye Institute. During these sessions the subject will be measured with a stationary topographer (GALILEI G4), with a rotatable topography measurement (Oculus Topographer) and a Tonometer. The subject's heart rate and blood pressure will also be measured (using a commercially available blood pressure and heart rate meter).
The GALILEI measurement will only be done once. The rest of the measurements will be done up to 4 times. Once at the start of the study session then, after the subject has been inverted using a commercially available inversion table to first 135 degrees, then 150 degrees and finally to 165 degrees.
The blood pressure and heart rate will be monitored to ensure subject safety.
There will also be one visit at the Massachusetts General Hospital. The visit will be 2 hours and will involve a Brillouin Microscopy measurement.
Intervention Type
Other
Intervention Name(s)
Inversion
Intervention Description
Inversions will be done while the subject is on the inversion table. The subject will be inverted to 135, 150 and 165 degrees. There inversion will not last longer than 3 minutes at a time. The inversion will be terminated if the subject's blood pressure drops below 50 mmHg diastolic or if the subject's blood pressure increases more than 50 mmHg systolic.
Primary Outcome Measure Information:
Title
Corneal Surface Topography Measurement
Description
Corneal Surface Topography measurement will be collected at each of the 3-4 study visits at the Flaum Eye Institute. The numerical data generated will be analyzed and compared within each subject as well as across subjects.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
A person is eligible for inclusion in the study if he/she:
Is an adult between the ages of 18 and 55.
Is under 250 pounds.
Exclusion Criteria
A person will be excluded from the study if he/she:
Is under the age of 18 or over the age of 55 yrs.
Weighs more than 250 pounds.
Has clinically significant dry eye.
Has glaucoma.
Has hypertension.
Has prior CVA.
Has cardiovascular disease.
Has lower extremity joint injury, damage, or replacement.
Has baseline bradycardia.
Has any orthopaedic injuries.
Is pregnant.
Has hiatal and ventral hernias.
Has vertigo.
Has acid reflux (GERD).
Is undergoing myopia control treatment (e.g. atropinisation, Ortho-K, bifocal contact lenses etc.).
Has conditions or has undergone procedures resulting in significant corneal irregularity (e.g. keratoconus, corneal transplant, etc.). This does not include astigmatism and basic refractive errors.
Has any ocular or systemic diseases that, in the opinion of the PI/SI, would interfere with obtaining a measurement.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geunyoung Yoon, PhD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Corneal Biomechanics Study
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