Using AI to improve small incision eye surgery outcomes
Artificial Intelligence Assisted Small Incision Lenticule Extraction (SMILE) for Surgical Design and Nomogram Predicting and Related Influencing Factors to Surgical Outcomes
This study is testing if using artificial intelligence during small incision eye surgery can lead to better vision results compared to predictions made by experienced surgeons.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Tianjin Eye Hospital Academic / other |
| Locations | 1 site (Tianjin, Tianjin) |
| Trial ID | NCT06229301 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the refractive outcomes of Small Incision Lenticule Extraction (SMILE) surgery when assisted by Artificial Intelligence versus predictions made by experienced surgeons. It will analyze various factors that influence these outcomes in patients who have undergone the procedure at the Refractive Surgery Center of Tianjin Eye Hospital. Data collected from participants will also be utilized for future case-control and cohort studies to enhance understanding of surgical design and effectiveness.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 and older with stable refraction and good corrected distance visual acuity.
Not a fit: Patients with abnormal corneal features, severe dry eye, or a history of eye surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes for patients undergoing myopia correction.
How similar studies have performed: While the use of AI in surgical design is a growing field, this specific approach comparing AI predictions to experienced surgeons is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tianjin, Tianjin
- Tianjin Eye Hospital — Tianjin, Tianjin, China (Recruiting)
Study contacts
- Study coordinator: Yan Wang
- Email: wangyan7143@vip.sina.com
- Phone: +82227313336
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.