- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07676747
Ralation Between Cardiorespiratory Fitness and Mean Corrected Intraocular Pressure
Cardiorespiratory Fitness and Mean Corrected Intraocular Pressure: A Cross-Sectional Study in a Normotensive Health Check-up Population
Objective: To investigate the association between cardiorespiratory fitness and mean corrected intraocular pressure (IOP) in a normotensive health check-up population, and to evaluate potential differences across age and sex strata.
Methods: This cross-sectional study consecutively enrolled adults aged 18-70 years who completed cardiorespiratory fitness testing and ophthalmologic examinations at the Health Management Center of Sichuan Provincial People's Hospital between July 1, 2019 and December 31, 2025. Individuals were excluded if they had a history of glaucoma, ocular diseases interfering with IOP measurement, systemic diseases or medications affecting IOP, contraindications to fitness testing, or abnormal blood pressure. A final sample of 2,921 normotensive individuals was included. Cardiorespiratory fitness was assessed by estimated maximal oxygen uptake (VO₂max). After age- and sex-stratified grouping, low cardiorespiratory fitness was used as the reference, and the remainder were defined as the moderate-to-high cardiorespiratory fitness group. The primary outcome was the mean corrected IOP of both eyes. Multiple imputation, multivariable linear regression, and age- and sex-stratified analyses were used to evaluate the association.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Sichuan
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Chengdu, Sichuan, Čína, 610000
- Sichuan Provinvial People's HSichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital( SAMS&SPPH,Affiliated Hospital of UESTC)ospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Age 18-70 years;
- Ability to complete standardized cardiorespiratory fitness testing and provide valid data; and
- Ability to cooperate with a comprehensive ophthalmologic examination.
Exclusion Criteria:
- Any history of glaucoma or ocular hypertension, or detection of glaucoma suspect signs such as cup-to-disc ratio ≥0.7, interocular cup-to-disc ratio asymmetry >0.2, or localized retinal nerve fiber layer defects;
- Ocular diseases or surgical history affecting IOP measurement or optic nerve head assessment, such as corneal disease, uveitis, intraocular surgery, high myopia (spherical equivalent ≤ -6.00 D), or other optic nerve/retinal diseases;
- Systemic diseases that could significantly interfere with IOP, optic nerve blood supply, or cardiorespiratory function, such as uncontrolled diabetes mellitus, severe cardiovascular or cerebrovascular disease, or chronic obstructive pulmonary disease;
- Current use of topical or systemic medications known to affect IOP, including IOP-lowering eyedrops, systemic beta-blockers, or glucocorticoids;
- Contraindications to cardiorespiratory fitness testing, such as severe musculoskeletal disorders or uncontrolled arrhythmias;
- A documented history of hypertension, current use of antihypertensive medications, or abnormal blood pressure on a single measurement that did not normalize on re-examination (systolic blood pressure [SBP] ≥140 mmHg or diastolic blood pressure [DBP] ≥90 mmHg); and
- Missing key study variables that precluded further analysis.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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low cardiorespiratory fitness
Cardiorespiratory fitness levels were classified based on age- and sex-stratified percentiles of VO₂max in the present study sample.
VO₂max ≤ the 25th percentile for the same age group and sex was defined as low cardiorespiratory fitness.
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Intraocular pressure (IOP) was measured in both eyes using a non-contact tonometer (CT-1P, Topcon Corporation, Tokyo, Japan).
The corrected IOP was automatically calculated by the device's built-in algorithm based on central corneal thickness.
In Chinese healthy adults, corneal thickness is significantly associated with sex and age, which has important clinical implications for the correction of IOP measurements.
To minimize the influence of diurnal fluctuation on IOP measurements, all IOP assessments were uniformly scheduled between 7:30 AM and 11:00 AM.
Two measurements were taken for each eye and the average was recorded.
The mean corrected IOP, defined as the average of the corrected IOP values of both eyes, was used as the primary outcome measure in this study.
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Moderate-to-high cardiorespiratory fitness
The remainder were defined as moderate-to-high cardiorespiratory fitness.
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Intraocular pressure (IOP) was measured in both eyes using a non-contact tonometer (CT-1P, Topcon Corporation, Tokyo, Japan).
The corrected IOP was automatically calculated by the device's built-in algorithm based on central corneal thickness.
In Chinese healthy adults, corneal thickness is significantly associated with sex and age, which has important clinical implications for the correction of IOP measurements.
To minimize the influence of diurnal fluctuation on IOP measurements, all IOP assessments were uniformly scheduled between 7:30 AM and 11:00 AM.
Two measurements were taken for each eye and the average was recorded.
The mean corrected IOP, defined as the average of the corrected IOP values of both eyes, was used as the primary outcome measure in this study.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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Mean corrected intraocular pressure (IOP) of both eyes
Časové okno: same day 1
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same day 1
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Ocular hypertension
Časové okno: same day 1
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IOP > 21 mmHg in one eye
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same day 1
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- SichuanAMS-2026-280
- 2023QN15 (Jiné číslo grantu/financování: Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital( SAMS&SPPH,Affiliated Hospital of UESTC))
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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