MyopiaNCT06577012
Potential Risk Factors and Predictive Model Construction of OBL During SMILE
An observational study of Myopia and Small-incision Lenticule Extraction (SMILE) Surgery, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
Trial summary
To explore the prediction of OBL by deep learning model in SMILE surgery Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Small-incision Lenticule Extraction (SMILE) Surgery
- What is being tested?
- Small incision lenticule extraction
- Type of treatment
- Surgery or procedure
- How many people
- 4,678 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 1 Aug 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
- Healthy volunteers accepted
- Adult
Study population: Patients from clinics in ophthalmic center of the second Affiliated Hospital of Nanchang University
Who may be able to join
- A condition in which the spherical equivalent refractive error of an eye is ≤ -0.50 D when ocular accommodation is relaxed;
- Age ≥18 years;
- Spherical equivalent (SE) ≥ -10.0D;
- Corrected distance visual acuity (CDVA) ≥ 16/20;
- Stable myopia for at least 2 years;
- No contact lenses wearing for at least 2 weeks
Who cannot join
- The presence or history of eye conditions other than myopia and astigmatism, such as keratoconus or external eye injury;
- A history of eye surgery;
- The presence or history of systemic diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000
About this study
Official title: Predicting an Opaque Bubble Layer During Small-Incision Lenticule Extraction Surgery Based on Deep Learning
To explore the prediction of OBL by deep learning model in SMILE surgery
Read the detailed description
The DL model was used to predict the OBL area during SMILE surgery by identifying the corneal full-view images before laser scanning. The DL model developed may assist surgeons to predict the possible OBL area of patients in advance, so as to adjust some surgical parameters and reduce the formation of OBL, which can avoid negative effects on surgeons' operation and patients' postoperative visual recovery, which has important practical significance.
- Being tested
- Small incision lenticule extraction
- Keywords
- small-incision lenticule extraction (SMILE), artificial intelligence, opaque bubble layer
- Medical subject headings
- Myopia, Smiling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small incision lenticule extractionProcedure or surgery
Small incision lenticule extraction surgeries performed by two Refractive surgery experts (Refractive surgery expert 1: YYF, Associate Professor with 10 years of experience as a refractive surgeon; Refractive surgery expert 2: GF, Associate Professor with 5 years of experience as a refractive surgeon) and a Attending ophthalmologist (XJ, Attending ophthalmologist with 1 year of experience as a refractive surgeon).
| Study group | Role | What they receive |
|---|---|---|
| Eyes with SMILE surgeries | Eyes with SMILE surgeries which were performed by three surgeons with different experiences. Receives: Procedure: Small incision lenticule extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area of patients with opaque bubble layer in the SMILE surgeries
The area of patients with opaque bubble layer were observed during the SMILE surgeries.
Measured: Day 0
Secondary outcomes (4)
Deep learning model
Predictive performance of deep learning model on the OBL in SMILE surgeries.
Measured: Day 0
ResNet model
Predictive performance of ResNet model on the OBL in SMILE surgeries.
Measured: Day 0
Vgg19 model
Predictive performance of Vgg model on the OBL in SMILE surgeries.
Measured: Day 0
U-net model
Predictive performance of U-net model on the OBL in SMILE surgeries.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start1 May 2024
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
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.
- More trials run by Second Affiliated Hospital of Nanchang UniversityThe sponsor's other registered studies.
- 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
- 4,678 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yifeng Yu, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577012
- Sponsor's protocol ID
- 2024086
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting an Opaque Bubble Layer During Small-Incision Lenticule Extraction Surgery Based on Deep Learning
- ClinicalTrials.gov ID
- NCT06577012
- Acronym / sponsor ID
- 2024086
- Keywords
- small-incision lenticule extraction (SMILE), artificial intelligence, opaque bubble layer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,678 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 29 Aug 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.
To explore the prediction of OBL by deep learning model in SMILE surgery
Detailed description
The DL model was used to predict the OBL area during SMILE surgery by identifying the corneal full-view images before laser scanning. The DL model developed may assist surgeons to predict the possible OBL area of patients in advance, so as to adjust some surgical parameters and reduce the formation of OBL, which can avoid negative effects on surgeons' operation and patients' postoperative visual recovery, which has important practical significance.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eyes with SMILE surgeries | – | Procedure: Small incision lenticule extractionEyes with SMILE surgeries which were performed by three surgeons with different experiences. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients from clinics in ophthalmic center of the second Affiliated Hospital of Nanchang University
Key inclusion criteria (6 listed)
- A condition in which the spherical equivalent refractive error of an eye is ≤ -0.50 D when ocular accommodation is relaxed;
- Age ≥18 years;
- Spherical equivalent (SE) ≥ -10.0D;
- Corrected distance visual acuity (CDVA) ≥ 16/20;
- Stable myopia for at least 2 years;
Key exclusion criteria (3 listed)
- The presence or history of eye conditions other than myopia and astigmatism, such as keratoconus or external eye injury;
- A history of eye surgery;
- The presence or history of systemic diseases.
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 |
|---|---|---|
| Small incision lenticule extractionSmall incision lenticule extraction surgeries performed by two Refractive surgery experts (Refractive surgery expert 1: YYF, Associate Professor with 10 years of experience as a refractive surgeon; Refractive surgery expert 2: GF, Associate Professor with 5 years of experience as a refractive surgeon) and a Attending ophthalmologist (XJ, Attending ophthalmologist with 1 year of experience as a refractive surgeon). | Procedure or surgery | Eyes with SMILE surgeries |
Primary outcome
The area of patients with opaque bubble layer in the SMILE surgeries
Time frame: Day 0
The area of patients with opaque bubble layer were observed during the SMILE surgeries.
4 secondary outcomes
Deep learning model
Time frame: Day 0
ResNet model
Time frame: Day 0
Vgg19 model
Time frame: Day 0
U-net model
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Individual participant dataSharing planned: No
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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 Small-incision Lenticule Extraction (SMILE) Surgery, run by Second Affiliated Hospital of Nanchang University 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 3 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: finished, as of the sponsor's last update on 29 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The area of patients with opaque bubble layer in the SMILE surgeries (time frame: Day 0). 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 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.