An interventional study of Sodium Hyaluronate Eye Drops in Dry Eye and Cataract, sponsored by Jin Yang. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by Jin Yang · Not applicable, Interventional, and Treatment
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.
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's planned enrollment of 400 is above the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Jin Yang is the lead sponsor of 7 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with age-related cataract who did not meet the diagnostic criteria for dry eye disease. Participants underwent ocular surface evaluation and repeated corneal astigmatism measurements using IOLMaster 700, Pentacam AXL, and iTrace Prime. No ocular surface treatment was administered in this cohort.
Patients with age-related cataract who met the diagnostic criteria for dry eye disease. Participants underwent baseline ocular surface evaluation and repeated corneal astigmatism measurements using IOLMaster 700, Pentacam AXL, and iTrace Prime. They then received 0.3% sodium hyaluronate eye drops four times daily for 2 weeks, followed by repeat ocular surface evaluation and device measurements using the same protocol.
Drug: Sodium Hyaluronate Eye Drops
0.3% sodium hyaluronate eye drops administered four times daily for 2 weeks in participants with dry eye disease.
Interdevice Agreement of Corneal Astigmatism Measurements
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.
Time frame: Baseline and 2 weeks after ocular surface treatment in the dry eye disease arm.
Test-Retest Repeatability of Corneal Astigmatism Measurements
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.
Time frame: Baseline and 2 weeks after ocular surface treatment in the dry eye disease arm.
Plan to share: No — Individual participant data will not be shared because the dataset contains patient-level clinical examination data. Deidentified aggregate data may be available from the corresponding author upon reasonable request, subject to institutional approval and applicable privacy regulations.
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Started Jan 2026 (actual). Primary completion is estimated for Jul 2026, 6 months after the start.
Of 199 non-industry interventional studies with no phase under Dry Eye Syndromes, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 25. This study's planned 6 months is below that.
Counting every sponsor, half of 312 studies reached it within 10 months; a quarter within 4 and three quarters within 18.
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Studies of the drug tested here: Hyaluronic Acid
Jin Yang