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Effect of Dry Eye and Ocular Surface Treatment on Agreement and Repeatability of Corneal Astigmatism Measurements Among Three Devices

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Eye and ENT hospital of Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Xuanqiao Lin, Doctor
1532483480@qq.com
+8615088920668
Backup
Baoxian Zhuo
1532483480@qq.com
Time Frame
Start Date: 2026-01-01
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 400
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Jin Yang

This content was sourced from clinicaltrials.gov