- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07604428
Intraocular Pressure During Static Apnea
Intraocular Pressure Changes During Dry Static Apnea in Breath-Hold Divers
Study Overview
Status
Conditions
Detailed Description
Breath-hold diving is associated with marked physiological changes, including hypoxemia, hypercapnia, bradycardia, and increases in blood pressure. The effect of prolonged breath-holding on intraocular pressure (IOP) remains insufficiently understood.
This prospective observational study investigated changes in intraocular pressure during dry static apnea (STA) in adult breath-hold divers. Participants performed breath-holds in a supine position after a standardized resting period.
Intraocular pressure was measured using a rebound tonometer (Icare Pro, Icare Finland Oy, Helsinki, Finland). Blood pressure was measured using an automated sphygmomanometer (Omron M6 Comfort, Omron Healthcare, Kyoto, Japan). Peripheral oxygen saturation and heart rate were continuously monitored using a pulse oximeter (Beurer PO 80, Beurer Healthcare, Germany).
Measurements were obtained at baseline, during apnea and after resumption of breathing.
The primary objective was to quantify changes in intraocular pressure during STA. Secondary objectives included assessment of physiological responses and analysis of their relationship with IOP changes.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Olomouc, Czechia, 77900
- Department of Ophthalmology, University Hospital Olomouc, Olomouc
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- age over 18 years
- breath-hold divers at the amateur or professional level
- signed informed consent
Exclusion Criteria:
- known intraocular hypertension or glaucoma
- refractive error > ±5.00 D
- history of an eye injury
- previous surgery for cataract, strabismus, or pars plana vitrectomy
- corneal disease
- acute eye infection
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Breath-hold divers
Adult amateur and professional breath-hold divers undergoing dry static apnea with repeated assessment of intraocular pressure, blood pressure, heart rate, and oxygen saturation before, during, and after apnea.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in intraocular pressure during dry static apnea
Time Frame: Baseline, during apnea and within 30 and 60 seconds after apnea
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Difference between baseline intraocular pressure and maximal intraocular pressure during apnea
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Baseline, during apnea and within 30 and 60 seconds after apnea
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Blood pressure changes
Time Frame: Before apnea, during apnea and within 60 and 120 seconds after apnea
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Changes in systolic, diastolic, and mean arterial pressure during dry static apnea
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Before apnea, during apnea and within 60 and 120 seconds after apnea
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Heart rate changes
Time Frame: Baseline, during apnea and within 30 and 60 seconds after apnea
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Changes in heart rate during dry static apnea
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Baseline, during apnea and within 30 and 60 seconds after apnea
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Peripheral oxygen saturation changes
Time Frame: Baseline, during apnea and within 30 and 60 seconds after apnea
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Changes in peripheral oxygen saturation during dry static apnea
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Baseline, during apnea and within 30 and 60 seconds after apnea
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pavla Potesilova, MD, Lensi Turnov s.r.o.
- Study Director: Marta Karhanova, MD, PhD, FEBO, University Hospital Olomouc and Palacky University Olomouc
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 103/26
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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