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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Hyaluronate Eye Drops | Drug | 0.3% sodium hyaluronate eye drops administered four times daily for 2 weeks in participants with dry eye disease. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuanqiao Lin, Doctor | Contact | +8615088920668 | 1532483480@qq.com | |
| Baoxian Zhuo | Contact | 1532483480@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Xuanqiao Lin, Doctor | Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye and ENT hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D002386 | Cataract |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D007905 | Lens Diseases |
| D012030 | Refractive Errors |
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