Corneal Biomechanics Study

Myopia Clinical Trial

Official title:

The Investigation of Corneal Biomechanics Through the Changes in the Intraocular Pressure

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03658239
• Other study ID #: 71844
• Status: Withdrawn
• Phase: N/A
• Start date: December 2018
• Est. completion date: December 2020

Study information

• Verified date: January 2020
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Other:
• Inversion
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months