The Response of Intraocular Pressure to Systemic Hypercapnia and Hyperoxia

NCT ID: NCT01325285

Last Updated: 2011-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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In response to changes in the composition of inhaled gases, blood vessels will dilate or constrict. As a result, hypercapnia or hyperoxia may affect the production and drainage of aqueous humour in the anterior chamber of the eye. The balance between the production and drainage of the aqueous humour determines the intraocular pressure. As this system is hydrodynamic, it is expected that any increase or decrease in the production of aqueous humour due to dilation or constriction of the capillaries within the ciliary body will be compensated by increased or decreased drainage at the trabecular meshwork. Therefore intraocular pressure is not expected to show a response to hypercapnia or hyperoxia, but this supposition needs to be tested in a stably controlled manner of inducing inhaled gas provocations. This study will measure the intraocular pressure at varying levels of hypercapnia and hyperoxia using a sequential rebreathing circuit and automated gas blender. This will allow the precise targeting and stable control of end-tidal partial pressure values of carbon dioxide and oxygen.

In this study, intraocular pressure will be measured at seven different inhaled gas stages. The seven stages are as follows:

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)

Conditions

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Intraocular Pressure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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RespirAct

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)

Intervention Type DEVICE

Other Intervention Names

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Inhaled gas provocations

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role collaborator

Thornhill Research

UNKNOWN

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role lead

Responsible Party

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University of Toronto, University of Waterloo, and Toronto Western Research Institute

Principal Investigators

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Christopher Hudson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

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Toronto Western Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Central Contacts

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Alanna Adleman, BSc

Role: CONTACT

416-603-5694

Tien Wong, BSc

Role: CONTACT

416-603-5694

Facility Contacts

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Alanna Adleman, BSc

Role: primary

416-603-5694

Tien Wong, BSc

Role: backup

416-603-5694

References

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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.

Reference Type BACKGROUND
PMID: 14977778 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17446225 (View on PubMed)

Other Identifiers

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10-0655

Identifier Type: -

Identifier Source: org_study_id

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