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The aim of this study is to further optimize the surgical input parameters for patients undergoing Small Incision Lenticule Extraction (SMILE) using the regression model established by the SMILE 4.0-VISULYZE system, thereby achieving satisfactory postoperative refractive outcomes.
In this study, patients scheduled for SMILE surgery at the investigators' hospital will be divided into two groups: a conventional group, where the input parameters are adjusted based on historical experience according to the patient's refractive error, and a 4.0-VISULYZE group, where the input parameters are optimized using the SMILE 4.0-VISULYZE system.
The investigators will compare the postoperative outcomes between the two groups, including uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), spherical power, cylindrical power, spherical equivalent (SE), and the proportions of patients achieving postoperative visual acuity ≥0.8, ≥1.0, and ≥1.2 at 1 day, 10 days, 1 month, 3 months, 6 months, and 1 year post-surgery. Additionally, the investigators will evaluate the proportions of patients with postoperative SE within ±0.50D and ±1.0D, as well as postoperative cylindrical power within ±0.50D and ±1.0D, to assess the efficacy and safety of the SMILE 4.0-VISULYZE system in treating refractive errors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 4.0-VISULYZE group | Experimental | The 4.0-VISULYZE group had their infusion rates precisely calibrated using 4.0-VISULYZE |
|
| traditional group | Active Comparator | The traditional group had their infusion rates based on past experience. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group 4.0-VISULYZE | Procedure | The 4.0-VISULYZE group had their infusion rates precisely calibrated using 4.0-VISULYZE |
|
| Measure | Description | Time Frame |
|---|---|---|
| spherical equivalent | Use autorefractor-keratometer and phoroptor to measure degree of myopia and astigmatism,then derive the spherical equivalent. | preoperative, postoperative 10 days, 1, 3, 6, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| uncorrected distance visual acuity | Use a standardized visual acuity chart (e.g., Snellen or LogMAR chart) | preoperative, postoperative 10 days, 1, 3, 6, 12 months |
| corrected distance visualacuity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Yu, professor | Contact | 86 15996621616 | yuying.2009@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Nantong University | Active, not recruiting | Nantong | Jiangsu | 226001 | China | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42328095 | Derived | Zhao L, Gao N, Liu E, Cheng X, Li J, Ji H, Yu Y. Comparative Validation of a VISULYZE-Based Nomogram for Predicting Visual Outcomes and Higher-Order Aberrations After SMILE in High Myopia. J Ophthalmol. 2026 Jun 18;2026:1918446. doi: 10.1155/joph/1918446. eCollection 2026. |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| traditional group | Procedure | The traditional group had their infusion rates based on past experience. |
|
Use autorefractor-keratometer and phoroptor
| preoperative, postoperative 10 days, 1, 3, 6, 12 months |
| The Affiliated Hospital of Nantong University |
| Recruiting |
| Nantong |
| Jiangsu |
| 226001 |
| China |
|