Effect of Dry Eye Treatment on Corneal Astigmatism Measurements

Recruiting now · Not applicable

Conditions studied: Dry Eye, Cataract

In brief

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.

Key facts

Study ID

NCT07657858

Run by

Jin Yang

People needed

400

Starts

2026-01-01

Expected to finish

2030-12-31

Last updated by the study team

2026-06-18

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Eye and ENT hospital of Fudan University — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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