NCT00570791

Brief Summary

The primary purpose of this study is to evaluate the effects of ocular physical properties on intraocular pressure (IOP) measurements in eyes with healthy corneas using the following instruments to measure IOP: Goldmann applanation tonometer, pneumotonometer, ocular blood flow pneumotonometer, Tono-Pen, Pascal Dynamic Contour Tonometer and the Schiotz Tonometer. Ocular physical properties to be evaluated are:varying (CCT), corneal curvature (CC), axial length, anterior chamber depth and scleral rigidity. The secondary purpose of this is to determine if there is a correlation between CCT and other ocular properties, and which instruments that measure these other ocular properties are most affected by CCT.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2005

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 29, 2005

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 11, 2007

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

September 23, 2024

Status Verified

September 1, 2024

Enrollment Period

6.3 years

First QC Date

December 7, 2007

Last Update Submit

September 20, 2024

Conditions

Keywords

CorneaTonometersGoldmann applanationTonopenShiotzPneumatonometer

Outcome Measures

Primary Outcomes (1)

  • Eye pressure

    Measured pressure in participants' eyes with six different tonometers

    one - two hours

Study Arms (2)

Effect of age on intraocular pressure

Correlation between age and IOP with GAT compared to other tonometers.

Device: Tonometer

Effect of CCT and IOP

Correlation between CCT and IOP among all tonometers

Device: Tonometer

Interventions

TonometerDEVICE

Tonometer devices used to measure IOP: Pascal Dynamic Contour Tonometer, Goldman Applanation Tonometer, Tono Pen, Reichart pneumatonometer, Langham Ocular Blood Flow, Schiotz Tonometer and ICare tonometer

Effect of CCT and IOPEffect of age on intraocular pressure

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Clinic Patients, City Residents

You may qualify if:

  • Age \> 19.
  • Patients may or may not be on IOP lowering medication.

You may not qualify if:

  • History of baseline corneal disease including but not limited to: Fuchs' Dystrophy, Keratoconus, Iridocorneal Endothelial Syndrome, Lattice Dystrophy, Map-Dot- Fingerprint Dystrophy, or a history of Stevens-Johnson Syndrome.
  • Wears hard or rigid contact lenses.
  • History of inflammatory eye disease.
  • History of ocular trauma within the past 6 months.
  • History of ocular infection within the last 3 months.
  • Any abnormality preventing reliable IOP readings.
  • Subject has demonstrated potential for non-compliance with the study protocol (e.g. dosing schedule, visit schedule, or study procedures).
  • History of severe hypersensitivity to topical fluorescein.
  • Pregnant or breast feeding women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Nebraska Medical Center, Department of Ophthalmolgy and Visual Sciences

Omaha, Nebraska, 68198-5540, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Carol B Toris, PhD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2007

First Posted

December 11, 2007

Study Start

June 29, 2005

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

September 23, 2024

Record last verified: 2024-09

Locations