Cardiorespiratory FitnessNCT07676747
Ralation Between Cardiorespiratory Fitness and Mean Corrected Intraocular Pressure
An observational study of Cardiorespiratory Fitness and Eye Disorders, run by Sichuan Academy of Medical Sciences at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiorespiratory Fitness, Eye Disorders
- What is being tested?
- Mean corrected intraocular pressure (IOP) of both eyes
- How many people
- 2,921 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 1 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This single-center cross-sectional study enrolled adults who underwent health check-ups, completed standardized cardiorespiratory fitness testing, and underwent ophthalmologic examinations at the Health Management Center of Sichuan Provincial People's Hospital from July 1, 2019 to December 31, 2025. After applying the predefined inclusion and exclusion criteria, 2,921 normotensive adults were included in the final analysis.
Who may be able to join
- Age 18-70 years;
- Ability to complete standardized cardiorespiratory fitness testing and provide valid data; and
- Ability to cooperate with a comprehensive ophthalmologic examination.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Sichuan Provinvial People's HSichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital（ SAMS&SPPH，Affiliated Hospital of UESTC）ospital
Chengdu, Sichuan, 610000
About this study
Official title: 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.
- Conditions
- Cardiorespiratory Fitness, Eye Disorders
- Being tested
- Mean corrected intraocular pressure (IOP) of both eyes
- Keywords
- cardiorespiratory fitness, cross-sectional study, normal blood pressure, mean adjusted intraocular pressure, maximal oxygen uptake
- Medical subject headings
- Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mean corrected intraocular pressure (IOP) of both eyesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Mean corrected intraocular pressure (IOP) of both eyes | |
| Moderate-to-high cardiorespiratory fitness | The remainder were defined as moderate-to-high cardiorespiratory fitness. Receives: Other: Mean corrected intraocular pressure (IOP) of both eyes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean corrected intraocular pressure (IOP) of both eyes
Measured: same day 1
Secondary outcomes (1)
Ocular hypertension
IOP > 21 mmHg in one eye
Measured: same day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Jul 2025
- Primary completion31 Dec 2025
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiorespiratory FitnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,921 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676747
- Sponsor's protocol ID
- SichuanAMS-2026-280
- Other IDs
- 2023QN15
- Status last verified
- Jul 2019
- First submitted
- 24 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiorespiratory Fitness and Mean Corrected Intraocular Pressure: A Cross-Sectional Study in a Normotensive Health Check-up Population
- ClinicalTrials.gov ID
- NCT07676747
- Acronym / sponsor ID
- SichuanAMS-2026-280
- Conditions
- Cardiorespiratory Fitness, Eye Disorders
- Keywords
- cardiorespiratory fitness, cross-sectional study, normal blood pressure, mean adjusted intraocular pressure, maximal oxygen uptake
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,921 participants (actual)
- Lead sponsor
- Sichuan Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low cardiorespiratory fitness | – | Other: Mean corrected intraocular pressure (IOP) of both eyesCardiorespiratory 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. |
| Moderate-to-high cardiorespiratory fitness | – | Other: Mean corrected intraocular pressure (IOP) of both eyesThe remainder were defined as moderate-to-high cardiorespiratory fitness. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This single-center cross-sectional study enrolled adults who underwent health check-ups, completed standardized cardiorespiratory fitness testing, and underwent ophthalmologic examinations at the Health Management Center of Sichuan Provincial People's Hospital from July 1, 2019 to December 31, 2025. After applying the predefined inclusion and exclusion criteria, 2,921 normotensive adults were included in the final analysis.
Key inclusion criteria (3 listed)
- Age 18-70 years;
- Ability to complete standardized cardiorespiratory fitness testing and provide valid data; and
- Ability to cooperate with a comprehensive ophthalmologic examination.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mean corrected intraocular pressure (IOP) of both eyesIntraocular 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. | Other | Moderate-to-high cardiorespiratory fitness, low cardiorespiratory fitness |
Primary outcome
Mean corrected intraocular pressure (IOP) of both eyes
Time frame: same day 1
1 secondary outcome
Ocular hypertension
Time frame: same day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiorespiratory Fitness and Eye Disorders, run by Sichuan Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean corrected intraocular pressure (IOP) of both eyes (time frame: same day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.