MyopiaNCT06973278
A Prospective Study on Clinical Effectiveness After SMILE Versus SMILE Xtra in Myopia
A study testing SMILE and SMILE Xtra in people with Myopia, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
To evaluate the clinical efficacy and refractive stability of SMILE Xtra compared to SMILE in patients with myopia Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Myopia
- What is being tested?
- SMILE and SMILE Xtra
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 1 Feb 2027
- Phase
- Interventional
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 50 years.
- High myopia with a manifest refraction spherical equivalent (MRSE) - 6.00D～-10.00D and refractive changes within ± 0.50D in the past two years;
- Best corrected distance visual acuity (CDVA) ≥ 20/25.
- Preoperative refractive status is stable (myopia progression not exceeding 0.50D per year for at least 2 years).
- Predicted residual stromal thickness (RST) ≥ 250μm after lenticule removal. 6.Soft contact lenses discontinued for at least 1 week, rigid contact lenses for at least 3 weeks, and orthokeratology lenses for at least 3 months.
Who cannot join
- The presence of other eye diseases: keratoconus or suspected keratoconus, active keratoconjunctivitis, severe dry eye, glaucoma, retinal diseases such as retinal tears or macular degeneration, etc.,
- The presence of significant corneal scarring or cataracts affects observation.
- Systemic diseases such as active systemic inflammation, connective tissue diseases, other conditions that prevent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Cong Jing, 17269769976, lucky_congjing@163.com
About this study
To evaluate the clinical efficacy and refractive stability of SMILE Xtra compared to SMILE in patients with myopia
- Conditions
- Myopia
- Being tested
- SMILE, SMILE Xtra
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMILEProcedure or surgery
Small Incision Lenticule Extraction
SMILE XtraProcedure or surgery
Small Incision Lenticule Extraction combined with Corneal Cross-linking (SMILE Xtra)
| Study group | Role | What they receive |
|---|---|---|
| SMILE Group | Active comparator | Not described Receives: Procedure: SMILE |
| SMILE Xtra | Experimental | Not described Receives: Procedure: SMILE Xtra |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity
Measured: 1 week, 1 month, 6 months, 12 months，24 months and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start1 Feb 2023
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (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.
- More trials run by Shanghai Zhongshan HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973278
- Sponsor's protocol ID
- B2024-267R
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 15 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on Clinical Effectiveness After SMILE Versus SMILE Xtra in Myopia
- ClinicalTrials.gov ID
- NCT06973278
- Acronym / sponsor ID
- B2024-267R
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 15 May 2025 (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 evaluate the clinical efficacy and refractive stability of SMILE Xtra compared to SMILE in patients with myopia
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMILE Group | Active comparator | Procedure: SMILE |
| SMILE Xtra | Experimental | Procedure: SMILE Xtra |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18 and 50 years.
- High myopia with a manifest refraction spherical equivalent (MRSE) - 6.00D～-10.00D and refractive changes within ± 0.50D in the past two years;
- Best corrected distance visual acuity (CDVA) ≥ 20/25.
- Preoperative refractive status is stable (myopia progression not exceeding 0.50D per year for at least 2 years).
- Predicted residual stromal thickness (RST) ≥ 250μm after lenticule removal. 6.Soft contact lenses discontinued for at least 1 week, rigid contact lenses for at least 3 weeks, and orthokeratology lenses for at least 3 months.
Key exclusion criteria (3 listed)
- The presence of other eye diseases: keratoconus or suspected keratoconus, active keratoconjunctivitis, severe dry eye, glaucoma, retinal diseases such as retinal tears or macular degeneration, etc.,
- The presence of significant corneal scarring or cataracts affects observation.
- Systemic diseases such as active systemic inflammation, connective tissue diseases, other conditions that prevent
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 |
|---|---|---|
| SMILESmall Incision Lenticule Extraction | Procedure or surgery | SMILE Group |
| SMILE XtraSmall Incision Lenticule Extraction combined with Corneal Cross-linking (SMILE Xtra) | Procedure or surgery | SMILE Xtra |
Primary outcome
visual acuity
Time frame: 1 week, 1 month, 6 months, 12 months，24 months and 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMILE and SMILE Xtra in people with Myopia, run by Shanghai Zhongshan 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 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: looking for participants now, as of the sponsor's last update on 15 May 2025. 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?
Contact Cong Jing (17269769976, lucky_congjing@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual acuity (time frame: 1 week, 1 month, 6 months, 12 months，24 months and 36 months). 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 15 May 2025.