Corneal Biomechanics Study

NCT03658239 | Withdrawn

• 1 other identifier: 71844
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Experimental

EXPERIMENTAL

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.

Other: Inversion

Interventions

Inversion OTHER

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.

Experimental

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is an adult between the ages of 18 and 55.
• Is under 250 pounds.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Rochester: lead

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Geunyoung Yoon, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: September 5, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: January 29, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share