NCT01325285

Brief Summary

The purpose of this study is to determine how intraocular pressure responds to changes in the levels of carbon dioxide or oxygen that a healthy individual inspires.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

February 15, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 29, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

August 18, 2011

Status Verified

November 1, 2010

Enrollment Period

1 month

First QC Date

February 15, 2011

Last Update Submit

August 17, 2011

Conditions

Keywords

Intraocular pressureHypercapniaHyperoxiaRebreathing circuit

Outcome Measures

Primary Outcomes (1)

  • Intraocular pressure

    Intraocular pressure will be measured using Goldmann applanation tonometry.

    Intraocular pressure will be measured during the study visit, ten minutes into each of the seven inhaled gas provocation stages

Secondary Outcomes (1)

  • Retinal blood flow

    Retinal blood flow will be measured during the second (optional) study visit, ten minutes into each of the seven inhaled gas provocation stages

Interventions

RespirActDEVICE

Participants will breathe through a mask connected to a sequential rebreathing circuit and gas blender. The following seven gas stages will be targeted for about 10 minutes each: 1. Baseline, measured in eye A (PETCO2=38mmHg and PETO2=100mmHg) 2. 10% hypercapnic increase, measured in eye A (PETCO2=42mmHg and PETO2=100mmHg) 3. 20% hypercapnic increase, measured in eye A (PETCO2=46mmHg and PETO2=100mmHg) 4. Baseline, measured in both eyes (PETCO2=38mmHg and PETO2=100mmHg) 5. 250% hyperoxic increase, measured in eye B (PETCO2=38mmHg and PETO2=250mmHg) 6. 500% hyperoxic increase, measured in eye B (PETCO2=38mmHg and PETO2=500mmHg) 7. Baseline, measured in eye B (PETCO2=38mmHg and PETO2=100mmHg)

Also known as: Inhaled gas provocations

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy young individuals (age 18-30)

You may qualify if:

  • Age range 18-30 years old
  • Visual acuity of 20/20 or better

You may not qualify if:

  • Refractive error \>±6.00 DS and/or ± 2.00 DC
  • History or presence of ocular disease
  • Family history of diabetes or glaucoma
  • History of intraocular or refractive surgery
  • Nursing or pregnant women
  • History of clinically diagnosed endocrine disease
  • History of vascular disease, cardiovascular disease, or any treated respiratory disorders (seasonal asthma excluded from this so long as subject not taking Rx at the time)
  • History of systemic hypertension
  • Habitual smoking
  • Use of medications that affect blood flow

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, Canada

Location

Related Publications (2)

  • Hosking SL, Harris A, Chung HS, Jonescu-Cuypers CP, Kagemann L, Roff Hilton EJ, Garzozi H. Ocular haemodynamic responses to induced hypercapnia and hyperoxia in glaucoma. Br J Ophthalmol. 2004 Mar;88(3):406-11. doi: 10.1136/bjo.2002.008995.

    PMID: 14977778BACKGROUND
  • Slessarev M, Han J, Mardimae A, Prisman E, Preiss D, Volgyesi G, Ansel C, Duffin J, Fisher JA. Prospective targeting and control of end-tidal CO2 and O2 concentrations. J Physiol. 2007 Jun 15;581(Pt 3):1207-19. doi: 10.1113/jphysiol.2007.129395. Epub 2007 Apr 19.

    PMID: 17446225BACKGROUND

MeSH Terms

Conditions

HypercapniaHyperoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christopher Hudson, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alanna Adleman, BSc

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 15, 2011

First Posted

March 29, 2011

Study Start

August 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

August 18, 2011

Record last verified: 2010-11

Locations