NCT00571012

Brief Summary

Intraocular pressure (IOP) varies with body position, with a significant increase occurring from the seated to the supine position. Previous research has indicated that the IOP increase cannot be explained by changes in episcleral venous pressure(blood flow leading away from the eye) alone. As well, previous research has indicated that aqueous flow rate is independent of body position. The purpose of this project was to determine if aqueous humor outflow facility varied with changes in posture.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2007

Shorter than P25 for all trials

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

Study Start

First participant enrolled

October 1, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
6 days 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
Last Updated

November 26, 2009

Status Verified

November 1, 2009

Enrollment Period

2 months

First QC Date

December 7, 2007

Last Update Submit

November 24, 2009

Conditions

Keywords

glaucomaoutflow facilityHealthy eye function

Outcome Measures

Primary Outcomes (1)

  • Looking for change in outflow facility with change in position

    4 minutes per position

Study Arms (1)

Only one group- A

Healthy young subjects aged 18-45.

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy young volunteers aged 18-45 will be recruited from Mayo Clinic employees and students, and local area residents.

You may qualify if:

  • Healthy, aged 18-45.
  • Subjects will be given a complete dilated eye exam and an updated medical history will be performed

You may not qualify if:

  • IOP greater than 22mmHg
  • Evidence of glaucomatous optic neuropathy
  • Poor fixation
  • Nystagmus
  • Tropias
  • Phorias
  • Recent infection
  • Corneal scarring preventing reliable tonometry
  • Evidence of pigment dispersion
  • Narrow angles
  • History of trauma or surgery
  • Systemic use of beta blockers or steroids
  • Diabetic eye disease, uveitis, high (\>6D) myopia or high(\>4D) hyperopia.
  • Patients with chronic medical conditions(eg: hypertension) will be allowed to participate as long as their medical condition has been under good control over the preceding 12 months.
  • Subjects will also need to have good cervical neck malleability and be able to meet the physical needs of the protocol which call for 4 minutes of neck extension.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Related Publications (1)

  • GALIN MA, McIVOR JW, MAGRUDER GB. Influence of position on intraocular pressure. Am J Ophthalmol. 1963 Apr;55:720-3. No abstract available.

    PMID: 13960329BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Deepan Selvadurai, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 7, 2007

First Posted

December 11, 2007

Study Start

October 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

November 26, 2009

Record last verified: 2009-11

Locations