Effect of Dry Eye Treatment on Corneal Astigmatism Measurements

NCT07657858 | Recruiting

• 1 other identifier: DryEye-2026-001
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye; Cataract

Keywords

Dry Eye Disease; Cataract; Corneal Astigmatism; Ocular Surface; ;Biometry

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and 2 weeks after ocular surface treatment in the dry eye disease arm.

Study Arms (2)

Control Cohort

NO INTERVENTION

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.

Dry Eye Disease Cohort

EXPERIMENTAL

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

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.

Dry Eye Disease Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jin Yang: lead

Study Sites (1)

Eye and ENT hospital of Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes; Cataract; Astigmatism

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Lens Diseases; Refractive Errors

Study Officials

• Xuanqiao Lin, Doctor

  Fudan University

  STUDY CHAIR

Central Study Contacts

Xuanqiao Lin, Doctor

CONTACT

+8615088920668; 1532483480@qq.com

Baoxian Zhuo

CONTACT

1532483480@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 18, 2026
• Study Start: January 1, 2026
• Primary Completion: July 31, 2026
• Study Completion (Estimated): December 31, 2030
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)