- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07604428
Intraocular Pressure During Static Apnea
Intraocular Pressure Changes During Dry Static Apnea in Breath-Hold Divers
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Olomouc, Tjekkiet, 77900
- Department of Ophthalmology, University Hospital Olomouc, Olomouc
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change in intraocular pressure during dry static apnea
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Blood pressure changes
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Pavla Potesilova, MD, Lensi Turnov s.r.o.
- Studieleder: Marta Karhanova, MD, PhD, FEBO, University Hospital Olomouc and Palacky University Olomouc
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 103/26
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