NCT01254149

Brief Summary

The primary purpose of this study is to determine whether topical ophthalmic anesthetics lower the intraocular pressure in the eye.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

December 2, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

January 17, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

1.2 years

First QC Date

December 2, 2010

Last Update Submit

August 29, 2023

Conditions

Normal Tension Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Measured pressures in subjects' eyes with and without anesthetics.

    Intraocular pressure is measured via Goldmann applanation tonometry, which is considered the standard method of measurement with and without anesthetics.

    30 minutes

Eligibility Criteria

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

Subjects 19 years of age and older with normal eyes and with ocular disease.

You may qualify if:

  • Subjects must be 19 years of age and older

You may not qualify if:

  • Corneal diseases including corneal transplants, corneal dystrophies, or trauma to the cornea that may prevent reliable tonometry of either eye.
  • Intolerant to topical Proparacaine and Benoxinate
  • Pregnant or nursing
  • years of age and younger.
  • Physical limitation preventing ability to obtain reliable intraocular measurements (e.g. difficulty positioning subjects in front of the slit lamp or inability to keep eyes open during the intraocular pressure checks).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center, Department of Ophthalmology

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Low Tension Glaucoma

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye DiseasesOptic Nerve Diseases

Study Officials

  • Nathan Welch, MD

    UNMC Department of Ophthalmology and Visual Sciences

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 2, 2010

First Posted

December 6, 2010

Study Start

January 17, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

September 1, 2023

Record last verified: 2023-08

Locations

US(1)