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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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.

China1 site
  • Tianjin Eye hospital

    Tianjin, Tianjin Municipality, 300020

Other trials in China

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 groups in NCT07544615
Study groupRoleWhat they receive
preoperative corneal refractive surgery3 months postoperative corneal refractive surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted22 Apr 2026
  2. Study start1 Jan 2018
  3. Primary completion1 Aug 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

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
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.

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.

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