Effect of Dry Eye Treatment on Corneal Astigmatism Measurements
Official title: Effect of Dry Eye and Ocular Surface Treatment on Agreement and Repeatability of Corneal Astigmatism Measurements Among Three Devices
Run by Eye & ENT Hospital of Fudan University · NCT07657858 · Data updated 2026-11-12
This study tests whether short-term treatment for dry eye changes how consistently three devices measure corneal astigmatism in people preparing for cataract surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | July 31, 2026 |
| Study ends | December 31, 2030 |
| Registry record updated | June 18, 2026 |
| Trial ID | NCT07657858 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with age-related cataract undergoing preoperative evaluation, with and without clinically diagnosed dry eye disease.
✕Probably not a fit
Patients with active ocular infections, recent ocular surgery, or those unable to complete repeated measurements may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, single-center study recruits patients undergoing preoperative cataract evaluation and groups them by presence of dry eye disease. Participants have ocular surface assessments and corneal astigmatism measurements repeated with three devices (IOLMaster 700, Pentacam AXL, iTrace Prime) to compare inter-device agreement and repeatability. In those with dry eye, 0.3% sodium hyaluronate eye drops are given four times daily for two weeks, after which measurements are repeated to assess short-term effects on measurement consistency. The primary aim is to see if dry eye disease alters how accurately and reliably multiple devices record keratometric and total corneal astigmatism, including vector components.
Why it matters
Potential benefit: If successful, the findings could improve preoperative planning by clarifying when dry eye treatment improves measurement reliability for cataract surgery.
How similar studies have gone: Previous research has shown dry eye can affect corneal measurements; this study builds on that work by testing short-term treatment effects across multiple devices.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Eye and ENT hospital of Fudan University
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Xuanqiao Lin, Doctor
- Email: 1532483480@qq.com
- Phone: +8615088920668
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.