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| Name | Class |
|---|---|
| Beihang University | OTHER |
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The goal of this observational study is to learn about the difference of refractive outcomes between Artificial Intelligence and experienced surgeon predicting Nomogram assist SMILE surgical design and the influenced factors of refractive outcomes in patients who underwent Small Incision Lenticule Extraction(SMILE) at the Refractive Surgery Center of Tianjin Eye Hospital. The main questions it aims to answer are:
In this ambispective observation study, to compare the difference of refractive outcomes between Artificial Intelligence and experienced surgeon predicting Nomogram assist SMILE surgical design and Analysis the influenced factors of refractive outcomes, patients have been continuously recruited and the data can then be used for further case-control and cohort studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experienced-nomogram Group | Patients who underwent Small incision lenticule extraction (SMILE) from March 2014 to October 2018 in Refractive Surgery Center of Tianjin Eye Hospital and had at least three months of postoperative follow-up were included in this group. The Nomogram were based on experience of the surgeon. | ||
| AI-nomogram Group 1 | Patients who underwent Small incision lenticule extraction (SMILE) from November 2018 to May 2021 in Refractive Surgery Center of Tianjin Eye Hospital and had at least three months of postoperative follow-up were included in this group. AI-predicted nomogram was obtained and used on patients who underwent surgery. |
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| AI-nomogram Group 2 | Patients who underwent Small incision lenticule extraction (SMILE) from January 2023 in Refractive Surgery Center of Tianjin Eye Hospital and had at least three months of postoperative follow-up were included in this group. The datasets used to train AI(Artificial Intelligence) models have been continuously updated for better accuracy since 2018, the newest AI-predicted nomogram was obtained and used on patients who underwent surgery. |
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| Good Surgical Effect and Changes of Biological Parameters | -0.50D < spherical equivalent (SE) < 0.50D | ||
| Poor Surgical Effect and Changes of Biological Parameters |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-predicted Nomogram | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diopter | Spherical Diopter, cylindrical diopters and axis by Manifest Refraction Test | 3 months after small incision lenticule extraction |
| Uncorrected Distance Visual Acuity (UDVA) | 3 months after small incision lenticule extraction | |
| Corrected Distance Visual Acuity (CDVA) | Before small incision lenticule extraction 3 months after small incision lenticule extraction |
| Measure | Description | Time Frame |
|---|---|---|
| Corvis ST Test Result | Using OCULUS Corvis ST Test to obtain biomechanical parameters describing the biomechanical properties of the cornea | Before small incision lenticule extraction and 3 months after small incision lenticule extraction |
| Aberration |
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Inclusion Criteria:
Exclusion Criteria:
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This ambispective study included 3246 eyes of 1643 patients with myopia or myopic astigmatism until September 2023. All of patients were accepted the SMILE surgery from May 2014 to June 2023 in Tianjin Eye Hospital. Additional participants will be recruited until September 30, 2024.
Baseline and postoperative measurements included uncorrected distance visual acuity (UDVA), CDVA, cycloplegic and manifest refraction, slit-lamp and fundus examination, corneal topography and intraocular pressure. Postoperative examinations were scheduled at 1 day, 1 week, 1 month and 3 months. Before surgery, all patients had received 0.5% levofloxacin eyedrops 4 times daily for 3 days.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Wang | Contact | +82227313336 | wangyan7143@vip.sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Yan Wang | Tiajin Eye Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Eye Hospital | Recruiting | Tianjin | Tianjin Municipality | China |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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spherical equivalent (SE) <-0.50D or >0.50D
Aberration measured by itrace
| 3 months after small incision lenticule extraction |
| Corneal Tomogram | Acquisition of corneal tomograms with the OCULUS Pentacam | Before small incision lenticule extraction and 3 months after small incision lenticule extraction |