NCT07676747

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,921

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 30, 2026

Completed
Last Updated

June 30, 2026

Status Verified

July 1, 2019

Enrollment Period

6 months

First QC Date

June 24, 2026

Last Update Submit

June 24, 2026

Conditions

Keywords

cardiorespiratory fitnesscross-sectional studynormal blood pressuremean adjusted intraocular pressuremaximal oxygen uptake

Outcome Measures

Primary Outcomes (1)

  • Mean corrected intraocular pressure (IOP) of both eyes

    same day 1

Secondary Outcomes (1)

  • Ocular hypertension

    same day 1

Study Arms (2)

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.

Other: Mean corrected intraocular pressure (IOP) of both eyes

Moderate-to-high cardiorespiratory fitness

The remainder were defined as moderate-to-high cardiorespiratory fitness.

Other: Mean corrected intraocular pressure (IOP) of both eyes

Interventions

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.

Moderate-to-high cardiorespiratory fitnesslow cardiorespiratory fitness

Eligibility Criteria

Age18 Years - 69 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Age 18-70 years;
  • Ability to complete standardized cardiorespiratory fitness testing and provide valid data; and
  • Ability to cooperate with a comprehensive ophthalmologic examination.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sichuan Provinvial People's HSichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital( SAMS&SPPH,Affiliated Hospital of UESTC)ospital

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Conditions

Eye Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2026

First Posted

June 30, 2026

Study Start

July 1, 2025

Primary Completion

December 31, 2025

Study Completion

March 1, 2026

Last Updated

June 30, 2026

Record last verified: 2019-07

Locations