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NCT07657858
Effect of Dry Eye Treatment on Corneal Astigmatism Measurements
Conditions: Dry Eye, Cataract
Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 400
Sponsor: Jin Yang
Location: Eye and ENT hospital of Fudan University Shanghai Shanghai Municipality
Summary
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07657858). StuddyBuddy aggregates publicly available trial information.