NCT07657858 Effect of Dry Eye Treatment on Corneal Astigmatism Measurements
| NCT ID | NCT07657858 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jin Yang |
| Condition | Dry Eye |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2026-01-01 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Contact & Investigator
Xuanqiao Lin, Doctor
STUDY CHAIR
Fudan University
Frequently Asked Questions
Who can join the NCT07657858 clinical trial?
This trial is open to participants of all sexes, studying Dry Eye. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07657858 currently recruiting?
Yes, NCT07657858 is actively recruiting participants. Contact the research team at 1532483480@qq.com for enrollment information.
Where is the NCT07657858 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07657858 clinical trial?
NCT07657858 is sponsored by Jin Yang. The principal investigator is Xuanqiao Lin, Doctor at Fudan University. The trial plans to enroll 400 participants.