Effect of Dry Eye Treatment on Corneal Astigmatism Measurements

Sponsor
Jin Yang
Study ID
NCT07657858
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sodium Hyaluronate Eye Drops — DRUG
    0.3% sodium hyaluronate eye drops administered four times daily for 2 weeks in participants with dry eye disease.

Study Details

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 Dates

First listed
Jun 18, 2026
Start date
Jan 1, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2026
Completion
Dec 31, 2030

Study Design

Enrollment
400 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Control Cohort
    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.
  • Experimental: Dry Eye Disease 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.

Primary Outcome Measure

Interdevice Agreement of Corneal Astigmatism Measurements [ Time Frame: Baseline and 2 weeks after ocular surface treatment in the dry eye disease arm. ]

Central Contacts

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