Effect of Dry Eye and Ocular Surface Treatment on Agreement and Repeatability of Corneal Astigmatism Measurements Among Three Devices
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 400
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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
Investigators
Jin Yang
Chief Physician
Eye & ENT Hospital of Fudan University