MyopiaAIOP-CRS-AINCT07544615
Assessment of IOP After Corneal Refractive Surgery Based on AI
An observational study of Myopia and Myopia; Astigmatism, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
Significance, Background, and Current Status Studies show the global average prevalence of myopia is 22%, with hyperopia incidence being similar. In China, the myopia prevalence is 31%, making it one of the countries with the highest rates of myopia. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Myopia; Astigmatism, Refractive Surgery
- How many people
- 10,030 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Dec 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: myopia and Myopic Astigmatism
Who may be able to join
- Normal preoperative IOP, no glaucoma or suspected glaucoma.
- Corneal thickness ≥ 480 μm.
- Discontinuation of rigid gas permeable contact lenses for ≥3 months and soft contact lenses for ≥2 weeks prior to examination.
- Clear cornea, no corneal leukoma, no history of ocular trauma.
- No previous ocular surgery.
- Willingness to participate and comply with all study examinations and procedures.
Who cannot join
- 1. Severe psychiatric disorders. 2. Ocular hypertension, suspected glaucoma, or glaucoma. 3. Concurrent other ocular diseases (e.g., corneal opacity, uveitis). 4. History of ocular surgery, trauma, or contact lens wear (as per inclusion criterion #3).
- 5. Nystagmus or inability to cooperate with examinations. 6. Presence of other ocular surface diseases, dry eye syndrome, fundus diseases, or systemic diseases affecting the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Actual Intraocular Pressure After Corneal Refractive Surgery Based on Big Data and Artificial Intelligence
Significance, Background, and Current Status Studies show the global average prevalence of myopia is 22%, with hyperopia incidence being similar. In China, the myopia prevalence is 31%, making it one of the countries with the highest rates of myopia. Currently, the safety and efficacy of corneal refractive surgery (CRS), such as LASIK and SMILE, for correcting myopia, hyperopia, and other refractive errors are well-established. An increasing number of patients undergo CRS to alleviate the inconveniences caused by refractive errors. While LASIK has long been regarded as a classic procedure, since the first report of Small Incision Lenticule Extraction (SMILE) for myopia correction in 2008, it has evolved into one of the mainstream surgical techniques. With the rapid advancement of refractive surgery, minimizing postoperative complications while maintaining excellent visual outcomes has become a major focus for clinicians. Postoperative intraocular pressure (IOP) monitoring is a crucial observation index.
Theoretically, IOP should not change significantly after CRS, as the surgery does not affect aqueous humor dynamics or intraocular volume. However, numerous studies indicate that alterations in corneal shape and biomechanical properties, particularly corneal thinning, lead to artificially low IOP readings with various tonometers, especially those dependent on corneal thickness. Furthermore, postoperative management often requires prolonged use of corticosteroid eye drops to suppress inflammation and promote wound healing. Extended steroid use can increase aqueous outflow resistance, elevating IOP, particularly in steroid responders, and potentially leading to steroid-induced glaucoma. Additionally, high myopia is a known risk factor for primary open-angle glaucoma. Therefore, based on preoperative and postoperative corneal parameter changes, rapidly and effectively determining the actual IOP range after CRS is of great significance for guiding clinical medication and screening for steroid-induced glaucoma.
Read more
Big Data and Artificial Intelligence (AI) are increasingly applied in medicine. AI primarily includes two technical branches: machine learning (ML) and deep learning. ML, a novel AI technology, has garnered significant interest in medical applications in recent years. It typically involves computer simulations that integrate human-like learning, refine knowledge structures, and continuously improve performance to aid diagnosis and intelligent decision-making, becoming a pivotal method in AI. Resembling neural network processes, ML systems are trained on selected input data using appropriate algorithms to produce corresponding outputs. It is now widely used to solve complex problems in engineering and science. In ophthalmology, AI/ML has gained attention for assisting in disease detection and monitoring, demonstrating advantages in fundus image diagnosis, keratoconus screening, and glaucoma classification. In corneal refractive surgery, ML has been applied to preoperative parameter design and outcome optimization, showing good safety, efficacy, and predictability. Preliminary attempts have been made to use AI decision trees to evaluate the safety and efficacy of CRS.
Building on this advanced technology and our previous research findings-which suggest that IOPcc and Pentacam-derived correction formulas (with the Shah correction method being preferable) provide relatively reliable IOP estimates after SMILE-this study aims to establish a data-driven model. Using Shah-corrected IOP as a reference to define postoperative IOP status, we will train and iteratively optimize a model by incorporating all relevant preoperative and postoperative parameters potentially affecting IOP. The goal is to predict the true IOP after CRS, thereby guiding postoperative follow-up, facilitating early detection of IOP elevation, and identifying potential glaucomatous tendencies.
Read the detailed description
IOP Changes and Value Prediction after FS-LASIK and SMILE A total of 350 patients undergoing SMILE and 350 undergoing FS-LASIK between October 1, 2023, and January 2, 2025, will be enrolled. Parameters including spherical equivalent (SE), central corneal thickness (CCT), mean keratometry (Km), residual stromal bed thickness (RST), percent tissue altered (PTA), and IOP values preoperatively and at 1 week, 1 month, and 2 months postoperatively will be recorded. These parameters will be included in a multiple linear regression model to analyze factors influencing postoperative IOP and derive a preliminary estimation formula for postoperative IOP measurements. Differences in IOP changes between the two surgical groups will be compared, and other influencing factors will be explored.
Assessment of IOP Measurement Levels after CRS Based on Machine Learning Data from approximately 10,300 SMILE and 11,000 FS-LASIK patients treated between October 1, 2020, and April 1, 2025, will be collected. Parameters affecting IOP, such as SE, CCT, Km, RST, and PTA, will be included to explore a predictive ML model for post-CRS IOP. The information gain algorithm will quantify the influence of various factors on postoperative IOP. Follow-up IOP measurements (preoperative, 1 week, 1 month, 2 months) and Pentacam Shah-corrected IOP will be recorded. The estimation formula from Study 1 will also be used to calculate postoperative IOP. Several different ML models will be constructed based on features with higher weights to build predictive models for judging IOP levels at follow-up timepoints. Clinical validation will be performed.
A cross-validation method will be employed to verify the model's effectiveness. Internal validation will first be conducted using the training dataset. The entire modeling dataset will be randomly divided into 10 equal folds. Nine folds will be used for model training, and the remaining fold will serve as the test set. The trained model will predict outcomes on the test set, and prediction errors will be calculated (e.g., sum of squared errors). This process will be repeated 10 times, each time with a different fold as the test set. The average performance across all 10 iterations will be reported.
- Keywords
- refractive surgery, intraocular pressure, Machine Learning, Predictive Model
- Medical subject headings
- Myopia, Astigmatism
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 |
|---|---|---|
| preoperative corneal refractive surgery | 3 months postoperative corneal refractive surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the Machine Learning Model in Predicting Postoperative Corneal-Compensated Intraocular Pressure (IOPcc)
The primary outcome is the predictive performance of the machine learning model. Performance will be evaluated by comparing the model-predicted intraocular pressure values against the reference standard-the Pentacam-derived corneal-compensated IOP (IOPcc) corrected using the Shah formula. Key evaluation metrics include the mean absolute error (MAE), root mean square error (RMSE), and the coefficient of determination (R²)
Measured: preoperative and 3 months postoperative of corneal refractive surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 Jan 2018
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
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
- Other
- Enrolment
- 10,030 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544615
- Sponsor's protocol ID
- KY-2025031
- Other IDs
- 82271118
- Acronym
- AIOP-CRS-AI
- Status last verified
- Apr 2026
- First submitted
- 14 Mar 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) generated and analyzed for this retrospective study are derived from existing electronic health records. Due to the sensitive nature of the clinical data and in compliance with our institutional data privacy and security policies, the underlying de-identified dataset cannot be made publicly available. The data were used under a specific protocol and data use agreement solely for the purposes of this study. Requests for aggregated results or methodological details can be directed to the corresponding author. Future data sharing would be subject to a formal review and approval process by the institutional data governance committee.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Actual Intraocular Pressure After Corneal Refractive Surgery Based on Big Data and Artificial Intelligence
- ClinicalTrials.gov ID
- NCT07544615
- Acronym / sponsor ID
- AIOP-CRS-AI / KY-2025031
- Keywords
- refractive surgery, intraocular pressure, Machine Learning, Predictive Model
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 10,030 participants (estimated)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 22 Apr 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.
Significance, Background, and Current Status Studies show the global average prevalence of myopia is 22%, with hyperopia incidence being similar. In China, the myopia prevalence is 31%, making it one of the countries with the highest rates of myopia. Currently, the safety and efficacy of corneal refractive surgery (CRS), such as LASIK and SMILE, for correcting myopia, hyperopia, and other refractive errors are well-established. An increasing number of patients undergo CRS to alleviate the inconveniences caused by refractive errors. While LASIK has long been regarded as a classic procedure, since the first report of Small Incision Lenticule Extraction (SMILE) for myopia correction in 2008, it has evolved into one of the mainstream surgical techniques. With the rapid advancement of refractive surgery, minimizing postoperative complications while maintaining excellent visual outcomes has become a major focus for clinicians. Postoperative intraocular pressure (IOP) monitoring is a crucial observation index.
Theoretically, IOP should not change significantly after CRS, as the surgery does not affect aqueous humor dynamics or intraocular volume. However, numerous studies indicate that alterations in corneal shape and biomechanical properties, particularly corneal thinning, lead to artificially low IOP readings with various tonometers, especially those dependent on corneal thickness. Furthermore, postoperative management often requires prolonged use of corticosteroid eye drops to suppress inflammation and promote wound healing. Extended steroid use can increase aqueous outflow resistance, elevating IOP, particularly in steroid responders, and potentially leading to steroid-induced glaucoma. Additionally, high myopia is a known risk factor for primary open-angle glaucoma. Therefore, based on preoperative and postoperative corneal parameter changes, rapidly and effectively determining the actual IOP range after CRS is of great significance for guiding clinical medication and screening for steroid-induced glaucoma.
Big Data and Artificial Intelligence (AI) are increasingly applied in medicine. AI primarily includes two technical branches: machine learning (ML) and deep learning. ML, a novel AI technology, has garnered significant interest in medical applications in recent years. It typically involves computer simulations that integrate human-like learning, refine knowledge structures, and continuously improve performance to aid diagnosis and intelligent decision-making, becoming a pivotal method in AI. Resembling neural network processes, ML systems are trained on selected input data using appropriate algorithms to produce corresponding outputs. It is now widely used to solve complex problems in engineering and science. In ophthalmology, AI/ML has gained attention for assisting in disease detection and monitoring, demonstrating advantages in fundus image diagnosis, keratoconus screening, and glaucoma classification. In corneal refractive surgery, ML has been applied to preoperative parameter design and outcome optimization, showing good safety, efficacy, and predictability. Preliminary attempts have been made to use AI decision trees to evaluate the safety and efficacy of CRS.
Building on this advanced technology and our previous research findings-which suggest that IOPcc and Pentacam-derived correction formulas (with the Shah correction method being preferable) provide relatively reliable IOP estimates after SMILE-this study aims to establish a data-driven model. Using Shah-corrected IOP as a reference to define postoperative IOP status, we will train and iteratively optimize a model by incorporating all relevant preoperative and postoperative parameters potentially affecting IOP. The goal is to predict the true IOP after CRS, thereby guiding postoperative follow-up, facilitating early detection of IOP elevation, and identifying potential glaucomatous tendencies.
Detailed description
IOP Changes and Value Prediction after FS-LASIK and SMILE A total of 350 patients undergoing SMILE and 350 undergoing FS-LASIK between October 1, 2023, and January 2, 2025, will be enrolled. Parameters including spherical equivalent (SE), central corneal thickness (CCT), mean keratometry (Km), residual stromal bed thickness (RST), percent tissue altered (PTA), and IOP values preoperatively and at 1 week, 1 month, and 2 months postoperatively will be recorded. These parameters will be included in a multiple linear regression model to analyze factors influencing postoperative IOP and derive a preliminary estimation formula for postoperative IOP measurements. Differences in IOP changes between the two surgical groups will be compared, and other influencing factors will be explored.
Assessment of IOP Measurement Levels after CRS Based on Machine Learning Data from approximately 10,300 SMILE and 11,000 FS-LASIK patients treated between October 1, 2020, and April 1, 2025, will be collected. Parameters affecting IOP, such as SE, CCT, Km, RST, and PTA, will be included to explore a predictive ML model for post-CRS IOP. The information gain algorithm will quantify the influence of various factors on postoperative IOP. Follow-up IOP measurements (preoperative, 1 week, 1 month, 2 months) and Pentacam Shah-corrected IOP will be recorded. The estimation formula from Study 1 will also be used to calculate postoperative IOP. Several different ML models will be constructed based on features with higher weights to build predictive models for judging IOP levels at follow-up timepoints. Clinical validation will be performed.
A cross-validation method will be employed to verify the model's effectiveness. Internal validation will first be conducted using the training dataset. The entire modeling dataset will be randomly divided into 10 equal folds. Nine folds will be used for model training, and the remaining fold will serve as the test set. The trained model will predict outcomes on the test set, and prediction errors will be calculated (e.g., sum of squared errors). This process will be repeated 10 times, each time with a different fold as the test set. The average performance across all 10 iterations will be reported.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| preoperative corneal refractive surgery | – | –3 months postoperative corneal refractive surgery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- myopia and Myopic Astigmatism
Key inclusion criteria (6 listed)
- Normal preoperative IOP, no glaucoma or suspected glaucoma.
- Corneal thickness ≥ 480 μm.
- Discontinuation of rigid gas permeable contact lenses for ≥3 months and soft contact lenses for ≥2 weeks prior to examination.
- Clear cornea, no corneal leukoma, no history of ocular trauma.
- No previous ocular surgery.
Key exclusion criteria (2 listed)
- 1. Severe psychiatric disorders. 2. Ocular hypertension, suspected glaucoma, or glaucoma. 3. Concurrent other ocular diseases (e.g., corneal opacity, uveitis). 4. History of ocular surgery, trauma, or contact lens wear (as per inclusion criterion #3).
- 5. Nystagmus or inability to cooperate with examinations. 6. Presence of other ocular surface diseases, dry eye syndrome, fundus diseases, or systemic diseases affecting the study.
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
Accuracy of the Machine Learning Model in Predicting Postoperative Corneal-Compensated Intraocular Pressure (IOPcc)
Time frame: preoperative and 3 months postoperative of corneal refractive surgery
The primary outcome is the predictive performance of the machine learning model. Performance will be evaluated by comparing the model-predicted intraocular pressure values against the reference standard-the Pentacam-derived corneal-compensated IOP (IOPcc) corrected using the Shah formula. Key evaluation metrics include the mean absolute error (MAE), root mean square error (RMSE), and the coefficient of determination (R²)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No. The individual participant data (IPD) generated and analyzed for this retrospective study are derived from existing electronic health records. Due to the sensitive nature of the clinical data and in compliance with our institutional data privacy and security policies, the underlying de-identified dataset cannot be made publicly available. The data were used under a specific protocol and data use agreement solely for the purposes of this study. Requests for aggregated results or methodological details can be directed to the corresponding author. Future data sharing would be subject to a formal review and approval process by the institutional data governance committee.
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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 Myopia; Astigmatism, run by Tianjin Eye Hospital 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 6 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 22 Apr 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?
This study is still under way. Results are not available in the source record yet.
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?
Accuracy of the Machine Learning Model in Predicting Postoperative Corneal-Compensated Intraocular Pressure (IOPcc) (time frame: preoperative and 3 months postoperative of corneal refractive surgery). 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 22 Apr 2026.