UnknownNot Applicable

A Study of Artificial Intelligence Assisted Small Incision Lenticule Extraction (SMILE) for Surgical Design and Influencing Factors

China3,000 participantsStarted 2014-03-01

Plain-language summary

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: * Compare the difference of refractive outcomes between Artificial Intelligence and experienced surgeon predicting Nomogram assist SMILE surgical design * Analysis the influenced factors of refractive outcomes

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age of 18 years and older * Stable refraction over the past 2 years * Corrected distance visual acuity (CDVA) of 20/25 or better * Soft contact lens discontinued 2 weeks or longer * Rigid contact lens discontinued 4 weeks or longer Exclusion Criteria: * Abnormal corneal topographic features * Severe dry eye * Active keratitis * Corneal scars * Keratoconus or suspected keratoconus, * Glaucoma * Retina diseases * History of intraocular or corneal surgery * Pregnant or lactating women, required chronic systemic corticosteroids or immunocompromised subjects were also excluded from this study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Diopter

Timeframe: 3 months after small incision lenticule extraction

Uncorrected Distance Visual Acuity (UDVA)

Timeframe: 3 months after small incision lenticule extraction

Corrected Distance Visual Acuity (CDVA)

Timeframe: Before small incision lenticule extraction 3 months after small incision lenticule extraction

Trial details

NCT IDNCT06229301

SponsorTianjin Eye Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-09-30

Contact for this trial

Yan Wang

+82227313336 wangyan7143@vip.sina.com

View on ClinicalTrials.gov More Myopia trials

Plain-language summary

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Diopter

Timeframe: 3 months after small incision lenticule extraction

Uncorrected Distance Visual Acuity (UDVA)

Timeframe: 3 months after small incision lenticule extraction

Corrected Distance Visual Acuity (CDVA)

Timeframe: Before small incision lenticule extraction 3 months after small incision lenticule extraction