MyopiaSMILENCT07478419
Machine Learning Prediction of 1-Year Refractive Error After SMILE
An observational study of Myopia and Myopic Astigmatism, run by Tongji University at 1 site in China.
Trial summary
This retrospective single-center observational study is designed to develop and internally validate a multi-output machine learning model for predicting 1-year postoperative refractive prediction error after small incision lenticule extraction (SMILE). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Myopia, Myopic Astigmatism, Refractive Error - Myopia Axial
- How many people
- 1,100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 31 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: People with moderate myopia who have undergone SMILE surgeries
Who may be able to join
- Eyes that underwent SMILE for correction of myopia or myopic astigmatism
- Availability of preoperative examination data and surgical planning data
- Availability of postoperative follow-up data at approximately 1 year
- Age ≥ 18 years
Who cannot join
- Previous ocular surgery in the study eye
- Ocular comorbidity likely to affect refractive or visual outcome
- Intraoperative or postoperative complications that precluded standard outcome assessment
- Missing key variables required for analysis
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
About this study
Official title: Development and Internal Validation of a Multi-output Machine Learning Model for Predicting 1-Year Postoperative Refractive Prediction Error After Small Incision Lenticule Extraction and Comparative Virtual Planning Analysis Against ZEISS 4.0
This retrospective single-center observational study is designed to develop and internally validate a multi-output machine learning model for predicting 1-year postoperative refractive prediction error after small incision lenticule extraction (SMILE). The primary modeling target is 1-year spherical equivalent prediction error. Secondary targets include J0 prediction error, J45 prediction error, and postoperative uncorrected distance visual acuity in logarithm of the minimum angle of resolution. A secondary objective is to use the prediction framework to derive individualized nomogram recommendations and to compare these recommendations with ZEISS 4.0 planning in a virtual treatment-planning analysis.
- Conditions
- Myopia, Myopic Astigmatism, Refractive Error - Myopia Axial
- Keywords
- Refractive Error, Small Incision Lenticule Extraction, Nomogram, Refractive Surgery
- Medical subject headings
- Myopia, Astigmatism, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Training Cohort | Eyes included in the prespecified training dataset for development of the multi-output machine learning model. | |
| Test Cohort | Eyes included in the prespecified independent test dataset for internal validation of the multi-output machine learning model. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Absolute Error of Predicted 1-Year Postoperative Spherical Equivalent Prediction Error
Model performance for prediction of 1-year postoperative spherical equivalent prediction error, assessed in diopters.
Measured: 1 year after SMILE
Secondary outcomes (2)
Mean Absolute Error of Predicted 1-Year Postoperative J0 Prediction Error
Model performance for prediction of the cardinal astigmatic vector component (J0), assessed in diopters.
Measured: 1 year after SMILE
Mean Absolute Error of Predicted 1-Year Postoperative J45 Prediction Error
Mean Absolute Error of Predicted 1-Year Postoperative J45 Prediction Error
Measured: 1 year after SMILE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Sep 2018
- Primary completion31 Dec 2025
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yuhao shao, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478419
- Sponsor's protocol ID
- 2026ML
- Other IDs
- SHDC12025144
- Acronym
- SMILE
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Internal Validation of a Multi-output Machine Learning Model for Predicting 1-Year Postoperative Refractive Prediction Error After Small Incision Lenticule Extraction and Comparative Virtual Planning Analysis Against ZEISS 4.0
- ClinicalTrials.gov ID
- NCT07478419
- Acronym / sponsor ID
- SMILE / 2026ML
- Conditions
- Myopia, Myopic Astigmatism, Refractive Error - Myopia Axial
- Keywords
- Refractive Error, Small Incision Lenticule Extraction, Nomogram, Refractive Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- Tongji UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This retrospective single-center observational study is designed to develop and internally validate a multi-output machine learning model for predicting 1-year postoperative refractive prediction error after small incision lenticule extraction (SMILE). The primary modeling target is 1-year spherical equivalent prediction error. Secondary targets include J0 prediction error, J45 prediction error, and postoperative uncorrected distance visual acuity in logarithm of the minimum angle of resolution. A secondary objective is to use the prediction framework to derive individualized nomogram recommendations and to compare these recommendations with ZEISS 4.0 planning in a virtual treatment-planning analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Cohort | – | –Eyes included in the prespecified training dataset for development of the multi-output machine learning model. |
| Test Cohort | – | –Eyes included in the prespecified independent test dataset for internal validation of the multi-output machine learning model. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- People with moderate myopia who have undergone SMILE surgeries
Key inclusion criteria (4 listed)
- Eyes that underwent SMILE for correction of myopia or myopic astigmatism
- Availability of preoperative examination data and surgical planning data
- Availability of postoperative follow-up data at approximately 1 year
- Age ≥ 18 years
Key exclusion criteria (4 listed)
- Previous ocular surgery in the study eye
- Ocular comorbidity likely to affect refractive or visual outcome
- Intraoperative or postoperative complications that precluded standard outcome assessment
- Missing key variables required for analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean Absolute Error of Predicted 1-Year Postoperative Spherical Equivalent Prediction Error
Time frame: 1 year after SMILE
Model performance for prediction of 1-year postoperative spherical equivalent prediction error, assessed in diopters.
2 secondary outcomes
Mean Absolute Error of Predicted 1-Year Postoperative J0 Prediction Error
Time frame: 1 year after SMILE
Mean Absolute Error of Predicted 1-Year Postoperative J45 Prediction Error
Time frame: 1 year after SMILE
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Myopia
Not yet recruitingObservational study
Corneal Biomechanics and Stromal Tissue Characteristics in Patients Undergoing SMILE
Myopia
Enrolling by invitation
Therapeutic Efficacy of Different Repeated Low-Intensity Red Light Devices and Different Usage Frequencies
Myopia
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruitingPhase 4
Odyssey Evaluation in Post LASIK Patients
Cataract
RecruitingPhase 3
A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
Myopia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia and Myopic Astigmatism, run by Tongji University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Absolute Error of Predicted 1-Year Postoperative Spherical Equivalent Prediction Error (time frame: 1 year after SMILE). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.