Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07657858

Effect of Dry Eye Treatment on Corneal Astigmatism Measurements

This prospective single-center study evaluates the effect of dry eye disease and short-term ocular surface treatment on the agreement and repeatability of corneal astigmatism measurements in patients with age-related cataract. Participants undergoing preoperative cataract evaluation are classified into a control group or a dry eye disease group according to ocular surface symptoms and objective tear film findings.

All participants undergo ocular surface assessment and repeated corneal measurements using three commonly used devices: IOLMaster 700, Pentacam AXL, and iTrace Prime. Measurements include keratometric corneal astigmatism, total corneal astigmatism, and vector components of astigmatism. Patients with dry eye disease receive 0.3% sodium hyaluronate eye drops four times daily for 2 weeks, after which ocular surface assessment and device measurements are repeated.

The primary objective is to determine whether dry eye disease reduces interdevice agreement and test-retest repeatability of corneal astigmatism measurements, and whether short-term ocular surface treatment improves measurement stability. Interdevice agreement is assessed using Bland-Altman analysis, and repeatability is evaluated using within-subject standard deviation, test-retest repeatability, and intraclass correlation coefficient.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Dry Eye Astigmatism Cataract Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases Lens Diseases Refractive Errors

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye and ENT hospital of Fudan University

Shanghai, Shanghai Municipality, 200000, China

Location status: Recruiting

Location contact

Xuanqiao Lin

CONTACT

[email protected]

15088920668

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with age-related cataract undergoing preoperative ocular examination.
  • Ability to complete ocular surface evaluation, including the Ocular Surface
  • Disease Index questionnaire, non-invasive tear film break-up time, tear meniscus height, Schirmer test, and ocular surface staining.
  • Ability to complete repeated corneal astigmatism measurements using IOLMaster 700, Pentacam AXL, and iTrace Prime.
  • Ability to maintain stable fixation during device measurements. Provision of written informed consent.

Exclusion criteria

  • Previous ocular surgery or ocular trauma.
  • Corneal degeneration, corneal dystrophy, or other corneal diseases that could affect corneal measurements.
  • Active corneal or conjunctival infection.
  • Uveitis.
  • Use of any topical eye drops within 24 hours before examination.
  • Use of antiglaucoma medications.
  • Contact lens wear within 1 month before examination.
  • Previous or ongoing treatment for dry eye disease.
  • Poor fixation during device measurements.
  • Poor-quality measurements from any study device

Treatment and study plan

Sodium hyaluronate eye drops

Drug

0.3% sodium hyaluronate eye drops administered four times daily for 2 weeks in participants with dry eye disease.

Primary outcomes

  1. Interdevice Agreement of Corneal Astigmatism Measurements

    Time frame: Baseline and 2 weeks after ocular surface treatment in the dry eye disease arm.

    Interdevice agreement of corneal astigmatism measurements among IOLMaster 700, Pentacam AXL, and iTrace Prime will be assessed using Bland-Altman analysis. Pairwise comparisons will be performed for IOLMaster 700 versus Pentacam AXL, IOLMaster 700 versus iTrace Prime, and Pentacam AXL versus iTrace Prime. The main parameters include keratometric corneal astigmatism, total corneal astigmatism, and their vector components J0 and J45. The mean difference and 95% limits of agreement will be calculated.

  2. Test-Retest Repeatability of Corneal Astigmatism Measurements

    Time frame: Baseline and 2 weeks after ocular surface treatment in the dry eye disease arm.

    Test-retest repeatability of corneal astigmatism measurements obtained using IOLMaster 700, Pentacam AXL, and iTrace Prime will be evaluated using three consecutive valid measurements from each device. The main parameters include keratometric corneal astigmatism, total corneal astigmatism, and their vector components J0 and J45. Repeatability will be assessed using within-subject standard deviation, test-retest repeatability calculated as 2.77 times the within-subject standard deviation, and intraclass correlation coefficient with 95% confidence intervals.

Study contacts

Contact information is provided by the study sponsor or research team.

Baoxian Zhuo

CONTACT

[email protected]

Xuanqiao Lin, Doctor

CONTACT

[email protected]

+8615088920668

Sponsors and collaborators

Lead sponsor

Jin Yang

Other

Registry information

Official study title

Effect of Dry Eye and Ocular Surface Treatment on Agreement and Repeatability of Corneal Astigmatism Measurements Among Three Devices

Important dates

Study start
2026
Primary completion
2026
Study completion
2030
First posted
Jun 18, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.