MyopiaNCT06229301
A Study of Artificial Intelligence Assisted Small Incision Lenticule Extraction (SMILE) for Surgical Design and Influencing Factors
An observational study of Myopia and Myopic Astigmatism, run by Tianjin Eye Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Myopia, Myopic Astigmatism
- What is being tested?
- AI-predicted Nomogram
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2014to 30 Sep 2024
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: This ambispective study included 3246 eyes of 1643 patients with myopia or myopic astigmatism until September 2023. All of patients were accepted the SMILE surgery from May 2014 to June 2023 in Tianjin Eye Hospital. Additional participants will be recruited until September 30, 2024. Baseline and postoperative measurements included uncorrected distance visual acuity (UDVA), CDVA, cycloplegic and manifest refraction, slit-lamp and fundus examination, corneal topography and intraocular pressure. Postoperative examinations were scheduled at 1 day, 1 week, 1 month and 3 months. Before surgery, all patients had received 0.5% levofloxacin eyedrops 4 times daily for 3 days.
Who may be able to join
- 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
Who cannot join
- Abnormal corneal topographic features
- Severe dry eye
- Active keratitis
- Corneal scars
- Keratoconus or suspected keratoconus,
- Glaucoma
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Eye Hospital
Tianjin, Tianjin Municipality
yan wang, director, +862227313336, wangyan7143@vip.sina.com
About this study
Official title: Artificial Intelligence Assisted Small Incision Lenticule Extraction (SMILE) for Surgical Design and Nomogram Predicting and Related Influencing Factors to Surgical Outcomes
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
Read the detailed description
In this ambispective observation study, to compare the difference of refractive outcomes between Artificial Intelligence and experienced surgeon predicting Nomogram assist SMILE surgical design and Analysis the influenced factors of refractive outcomes, patients have been continuously recruited and the data can then be used for further case-control and cohort studies.
- Conditions
- Myopia, Myopic Astigmatism
- Being tested
- AI-predicted Nomogram
- Keywords
- Small-incision Lenticule Extraction, Artificial Intelligence, Nomogram, Refractive Surgery, Myopia Correction
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-predicted NomogramProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Experienced-nomogram Group | Patients who underwent Small incision lenticule extraction (SMILE) from March 2014 to October 2018 in Refractive Surgery Center of Tianjin Eye Hospital and had at least three months of postoperative follow-up were included in this group. The Nomogram were based on experience of the surgeon. | |
| AI-nomogram Group 1 | Patients who underwent Small incision lenticule extraction (SMILE) from November 2018 to May 2021 in Refractive Surgery Center of Tianjin Eye Hospital and had at least three months of postoperative follow-up were included in this group. AI-predicted nomogram was obtained and used on patients who underwent surgery. Receives: Procedure: AI-predicted Nomogram | |
| AI-nomogram Group 2 | Patients who underwent Small incision lenticule extraction (SMILE) from January 2023 in Refractive Surgery Center of Tianjin Eye Hospital and had at least three months of postoperative follow-up were included in this group. The datasets used to train AI(Artificial Intelligence) models have been continuously updated for better accuracy since 2018, the newest AI-predicted nomogram was obtained and used on patients who underwent surgery. Receives: Procedure: AI-predicted Nomogram | |
| Good Surgical Effect and Changes of Biological Parameters | -0.50D < spherical equivalent (SE) < 0.50D | |
| Poor Surgical Effect and Changes of Biological Parameters | spherical equivalent (SE) <-0.50D or >0.50D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diopter
Spherical Diopter, cylindrical diopters and axis by Manifest Refraction Test
Measured: 3 months after small incision lenticule extraction
Uncorrected Distance Visual Acuity (UDVA)
Measured: 3 months after small incision lenticule extraction
Corrected Distance Visual Acuity (CDVA)
Measured: Before small incision lenticule extraction 3 months after small incision lenticule extraction
Secondary outcomes (3)
Corvis ST Test Result
Using OCULUS Corvis ST Test to obtain biomechanical parameters describing the biomechanical properties of the cornea
Measured: Before small incision lenticule extraction and 3 months after small incision lenticule extraction
Aberration
Aberration measured by itrace
Measured: 3 months after small incision lenticule extraction
Corneal Tomogram
Acquisition of corneal tomograms with the OCULUS Pentacam
Measured: Before small incision lenticule extraction and 3 months after small incision lenticule extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start1 Mar 2014
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (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
- Other
- Time perspective
- Other
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beihang University
- Responsible party
- Sponsor
- Investigators
- Yan Wang, Study chair, Tiajin Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229301
- Sponsor's protocol ID
- KY-2023076
- Status last verified
- Jan 2024
- First submitted
- 16 Dec 2023
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence Assisted Small Incision Lenticule Extraction (SMILE) for Surgical Design and Nomogram Predicting and Related Influencing Factors to Surgical Outcomes
- ClinicalTrials.gov ID
- NCT06229301
- Acronym / sponsor ID
- KY-2023076
- Conditions
- Myopia, Myopic Astigmatism
- Keywords
- Small-incision Lenticule Extraction, Artificial Intelligence, Nomogram, Refractive Surgery, Myopia Correction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Collaborators
- Beihang University
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 29 Jan 2024 (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.
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
Detailed description
In this ambispective observation study, to compare the difference of refractive outcomes between Artificial Intelligence and experienced surgeon predicting Nomogram assist SMILE surgical design and Analysis the influenced factors of refractive outcomes, patients have been continuously recruited and the data can then be used for further case-control and cohort studies.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Experienced-nomogram Group | – | –Patients who underwent Small incision lenticule extraction (SMILE) from March 2014 to October 2018 in Refractive Surgery Center of Tianjin Eye Hospital and had at least three months of postoperative follow-up were included in this group. The Nomogram were based on experience of the surgeon. |
| AI-nomogram Group 1 | – | Procedure: AI-predicted NomogramPatients who underwent Small incision lenticule extraction (SMILE) from November 2018 to May 2021 in Refractive Surgery Center of Tianjin Eye Hospital and had at least three months of postoperative follow-up were included in this group. AI-predicted nomogram was obtained and used on patients who underwent surgery. |
| AI-nomogram Group 2 | – | Procedure: AI-predicted NomogramPatients who underwent Small incision lenticule extraction (SMILE) from January 2023 in Refractive Surgery Center of Tianjin Eye Hospital and had at least three months of postoperative follow-up were included in this group. The datasets used to train AI(Artificial Intelligence) models have been continuously updated for better accuracy since 2018, the newest AI-predicted nomogram was obtained and used on patients who underwent surgery. |
| Good Surgical Effect and Changes of Biological Parameters | – | –-0.50D < spherical equivalent (SE) < 0.50D |
| Poor Surgical Effect and Changes of Biological Parameters | – | –spherical equivalent (SE) <-0.50D or >0.50D |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This ambispective study included 3246 eyes of 1643 patients with myopia or myopic astigmatism until September 2023. All of patients were accepted the SMILE surgery from May 2014 to June 2023 in Tianjin Eye Hospital. Additional participants will be recruited until September 30, 2024. Baseline and postoperative measurements included uncorrected distance visual acuity (UDVA), CDVA, cycloplegic and manifest refraction, slit-lamp and fundus examination, corneal topography and intraocular pressure. Postoperative examinations were scheduled at 1 day, 1 week, 1 month and 3 months. Before surgery, all patients had received 0.5% levofloxacin eyedrops 4 times daily for 3 days.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Abnormal corneal topographic features
- Severe dry eye
- Active keratitis
- Corneal scars
- Keratoconus or suspected keratoconus,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-predicted Nomogram | Procedure or surgery | AI-nomogram Group 1, AI-nomogram Group 2 |
Primary outcome
Diopter
Time frame: 3 months after small incision lenticule extraction
Spherical Diopter, cylindrical diopters and axis by Manifest Refraction Test
Uncorrected Distance Visual Acuity (UDVA)
Time frame: 3 months after small incision lenticule extraction
Corrected Distance Visual Acuity (CDVA)
Time frame: Before small incision lenticule extraction 3 months after small incision lenticule extraction
3 secondary outcomes
Corvis ST Test Result
Time frame: Before small incision lenticule extraction and 3 months after small incision lenticule extraction
Aberration
Time frame: 3 months after small incision lenticule extraction
Corneal Tomogram
Time frame: Before small incision lenticule extraction and 3 months after small incision lenticule extraction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
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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.
Yan Wang study chair
Tiajin Eye Hospital
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 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 29 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Wang (+82227313336, wangyan7143@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diopter (time frame: 3 months after small incision lenticule extraction). The study lists 3 primary outcomes in all. 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 29 Jan 2024.