- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01325285
The Response of Intraocular Pressure to Systemic Hypercapnia and Hyperoxia
Study Overview
Detailed Description
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:
- Baseline, measured in eye A (PETCO2=38mmHg and PETO2=100mmHg)
- 10% hypercapnic increase, measured in eye A (PETCO2=42mmHg and PETO2=100mmHg)
- 20% hypercapnic increase, measured in eye A (PETCO2=46mmHg and PETO2=100mmHg)
- Baseline, measured in both eyes (PETCO2=38mmHg and PETO2=100mmHg)
- 250% hyperoxic increase, measured in eye B (PETCO2=38mmHg and PETO2=250mmHg)
- 500% hyperoxic increase, measured in eye B (PETCO2=38mmHg and PETO2=500mmHg)
- Baseline, measured in eye B (PETCO2=38mmHg and PETO2=100mmHg)
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Alanna Adleman, BSc
- Phone Number: 416-603-5694
- Email: aadleman@uhnresearch.ca
Study Contact Backup
- Name: Tien Wong, BSc
- Phone Number: 416-603-5694
- Email: twong@uhnresearch.ca
Study Locations
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Ontario
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Toronto, Ontario, Canada
- Toronto Western Hospital
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Contact:
- Alanna Adleman, BSc
- Phone Number: 416-603-5694
- Email: aadleman@uhnresearch.ca
-
Contact:
- Tien Wong, BSc
- Phone Number: 416-603-5694
- Email: twong@uhnresearch.ca
-
Sub-Investigator:
- Joseph Fisher, FRCPC, MD
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Sub-Investigator:
- Richard Cheng, BSc
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intraocular pressure
Time Frame: Intraocular pressure will be measured during the study visit, ten minutes into each of the seven inhaled gas provocation stages
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Retinal blood flow
Time Frame: Retinal blood flow will be measured during the second (optional) study visit, ten minutes into each of the seven inhaled gas provocation stages
|
Retinal blood flow will be measured using the Canon Laser Blood Flowmeter in a subset of participants asked to return for a second visit.
This will demonstrate that retinal blood flow behaves as the study claims that it does.
|
Retinal blood flow will be measured during the second (optional) study visit, ten minutes into each of the seven inhaled gas provocation stages
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-0655
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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