MyopiaSMILENCT07906327
Corneal Biomechanics and Stromal Tissue Characteristics in Patients Undergoing SMILE
An observational study of Myopia, run by Tongji University at 1 site in China.
Trial summary
This prospective observational cohort study will investigate corneal biomechanical characteristics and their relationships with corneal stromal tissue features in adult patients undergoing clinically indicated small-incision lenticule extraction (SMILE). 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
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2026to 31 Jul 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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
Study population: Adult patients attending the refractive surgery service at [institution, city, China] who are scheduled for clinically indicated SMILE will be screened. All patients meeting the eligibility criteria during the recruitment period will be invited to participate. The study population represents patients selected for SMILE and is not intended to represent all individuals with myopia.
Who may be able to join
- Age 18 years or older.
- Scheduled to undergo SMILE based on routine clinical assessment.
- At least one eligible eye with a manifest refractive spherical equivalent of -0.50 diopters or more myopic.
- Meets the institution's clinical criteria for SMILE, including refractive stability and contact lens discontinuation requirements.
- Able to provide written informed consent for clinical data collection, lenticule retention, and follow-up.
- Willing to attend scheduled postoperative assessments through 12 months.
Who cannot join
- Previous corneal refractive surgery or other surgery affecting corneal biomechanical assessment in the study eye.
- Known or suspected keratoconus, corneal ectasia, or clinically significant corneal scarring.
- Active ocular infection or inflammation.
- Diagnosed glaucoma or other ocular disease expected to materially affect interpretation of the study measurements.
- Systemic disease or medication use considered by the investigator to materially affect corneal wound healing or biomechanical assessment.
- Inability to provide informed consent or complete the required baseline examinations.
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
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
jun zou, Associate Professor and Deputy, 13817572208, zoujun70@126.com
jun zou, DR
About this study
Official title: Corneal Biomechanical Phenotypes, Stromal Tissue Characteristics, and One-Year Postoperative Changes in Patients Undergoing SMILE: A Prospective Observational Cohort Study
This prospective observational cohort study will investigate corneal biomechanical characteristics and their relationships with corneal stromal tissue features in adult patients undergoing clinically indicated small-incision lenticule extraction (SMILE).
Participants will undergo standardized preoperative examinations, including Corvis ST assessment, refraction, axial length measurement, and corneal imaging. Corneal lenticules removed during routine SMILE surgery will be collected with informed consent and linked to clinical measurements from the corresponding eye using coded identifiers.
Read more
The primary objective is to compare preoperative stiffness parameter at first applanation (SP-A1) between patients with high myopia and those with non-high myopia. Secondary objectives are to characterize postoperative biomechanical changes and clinical outcomes during 12 months of follow-up. Exploratory analyses will investigate relationships between stromal tissue characteristics and clinical biomechanical measurements.
Surgical eligibility, surgical parameters, and postoperative care will be determined according to routine clinical practice independently of study participation. No additional corneal tissue will be removed for research.
Read the detailed description
Eligible adult patients scheduled for SMILE at [institution] will be consecutively screened and invited to participate after ethics approval and public study registration have been completed. Written informed consent will be obtained before study-specific procedures.
Baseline examinations will be performed before surgery and will include medical and ocular history, visual acuity, manifest refraction, axial length, intraocular pressure, corneal thickness and tomography, and Corvis ST measurements. Acquisition conditions, measurement quality, and device software versions will be recorded according to a standardized examination procedure.
One primary study eye will be selected before surgery. If both eyes are eligible, the primary study eye will be selected using a computer-generated random procedure before tissue results are available. Measurements and specimens from the fellow eye may be retained for separately identified exploratory analyses.
Participants will be classified according to the preoperative manifest refractive spherical equivalent of the primary study eye. High myopia will be defined as a spherical equivalent of -6.00 diopters or more myopic. Non-high myopia will be defined as a spherical equivalent of -0.50 diopters or more myopic but less myopic than -6.00 diopters.
Corneal lenticules removed during clinically indicated SMILE will be collected using a standardized handling and storage procedure. Each specimen will be linked to participant identifier, eye laterality, surgery date, and relevant surgical parameters. Structural and molecular analyses will investigate stromal remodeling and extracellular matrix characteristics. Specific assays and quantitative readouts will be documented in the protocol or a dated substudy analysis plan before the corresponding analyses.
Postoperative assessments will be scheduled at 1, 3, and 12 months after SMILE. Visual acuity, manifest refraction, intraocular pressure, corneal thickness, and Corvis ST measurements will be collected. Relevant medications, complications, and additional ocular procedures will be documented.
The primary analysis will compare baseline SP-A1 between the two refractive groups. Prespecified covariates will include age, sex, central corneal thickness, and intraocular pressure. Axial length will be examined as a continuous exposure in a separate supporting analysis.
Longitudinal models will account for repeated measurements. Analyses incorporating fellow eyes will additionally account for within-participant correlation. Estimates will be reported with 95% confidence intervals. Missing measurements, unavailable specimens, and reasons for loss to follow-up will be documented. Tissue analyses will use the corresponding-eye clinical measurements and will distinguish individual specimens from pooled samples.
Additional analyses of coded data or retained specimens will remain subject to participant consent and ethics approval. New confirmatory hypotheses will require dated analysis plans. Any exploratory prediction models will be evaluated offline and will not determine patient treatment.
- Conditions
- Myopia
- Being tested
- SMILE
- Keywords
- High Myopia, Corneal Biomechanics, SMILE, Corvis ST, Corneal Stroma, Extracellular Matrix
- 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
Clinically indicated SMILE performed according to routine clinical practice. Surgical selection and treatment parameters are not assigned by the research protocol. Removed lenticules will be retained with informed consent.
| Study group | Role | What they receive |
|---|---|---|
| High Myopia | Patients undergoing clinically indicated SMILE whose primary study eye has a preoperative manifest refractive spherical equivalent of -6.00 diopters or more myopic. Receives: Procedure: SMILE | |
| Non-High Myopia | Patients undergoing clinically indicated SMILE whose primary study eye has a preoperative manifest refractive spherical equivalent of -0.50 diopters or more myopic but less myopic than -6.00 diopters. Receives: Procedure: SMILE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative Stiffness Parameter at First Applanation (SP-A1)
SP-A1 will be obtained from quality-accepted Corvis ST measurements of the primary study eye. The acquisition and repeat-measurement rules will be standardized before enrollment. The primary comparison will estimate the difference in baseline SP-A1 between the high-myopia and non-high-myopia groups.
Measured: Baseline, 1year
Secondary outcomes (4)
Preoperative Integrated Inverse Radius
Integrated inverse radius will be obtained from quality-accepted Corvis ST measurements of the primary study eye and compared between the prespecified refractive groups.
Measured: Baseline, 1year
Change in SP-A1 From Baseline to 12 Months
Change will be calculated as SP-A1 at 12 months after SMILE minus preoperative SP-A1 in the primary study eye. Associations with baseline clinical characteristics and surgical parameters will be examined using prespecified analyses.
Measured: Baseline, 1year
Manifest Refractive Spherical Equivalent at 12 Months
Manifest refractive spherical equivalent will be calculated as sphere plus one-half of cylinder, expressed in diopters, for the primary study eye.
Measured: 1year
Early Postoperative Changes in SP-A1
Changes from preoperative SP-A1 will be calculated separately at 1 and 3 months after SMILE to characterize the early postoperative trajectory.
Measured: 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start25 Oct 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Jul 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.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Tongji University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yuhao shao, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906327
- Sponsor's protocol ID
- corvisST
- Acronym
- SMILE
- Status last verified
- Nov 2026
- First submitted
- 24 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision regarding sharing of de-identified individual participant data will be made in accordance with participant consent, institutional policies, ethics approval, and applicable requirements. Any future sharing plan will specify the eligible datasets, access conditions, and supporting documentation.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Biomechanical Phenotypes, Stromal Tissue Characteristics, and One-Year Postoperative Changes in Patients Undergoing SMILE: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07906327
- Acronym / sponsor ID
- SMILE / corvisST
- Conditions
- Myopia
- Keywords
- High Myopia, Corneal Biomechanics, SMILE, Corvis ST, Corneal Stroma, Extracellular Matrix
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tongji UniversityUniversity, hospital or other
- Study start
- 25 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 30 Oct 2026 (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.
This prospective observational cohort study will investigate corneal biomechanical characteristics and their relationships with corneal stromal tissue features in adult patients undergoing clinically indicated small-incision lenticule extraction (SMILE).
Participants will undergo standardized preoperative examinations, including Corvis ST assessment, refraction, axial length measurement, and corneal imaging. Corneal lenticules removed during routine SMILE surgery will be collected with informed consent and linked to clinical measurements from the corresponding eye using coded identifiers.
The primary objective is to compare preoperative stiffness parameter at first applanation (SP-A1) between patients with high myopia and those with non-high myopia. Secondary objectives are to characterize postoperative biomechanical changes and clinical outcomes during 12 months of follow-up. Exploratory analyses will investigate relationships between stromal tissue characteristics and clinical biomechanical measurements.
Surgical eligibility, surgical parameters, and postoperative care will be determined according to routine clinical practice independently of study participation. No additional corneal tissue will be removed for research.
Detailed description
Eligible adult patients scheduled for SMILE at [institution] will be consecutively screened and invited to participate after ethics approval and public study registration have been completed. Written informed consent will be obtained before study-specific procedures.
Baseline examinations will be performed before surgery and will include medical and ocular history, visual acuity, manifest refraction, axial length, intraocular pressure, corneal thickness and tomography, and Corvis ST measurements. Acquisition conditions, measurement quality, and device software versions will be recorded according to a standardized examination procedure.
One primary study eye will be selected before surgery. If both eyes are eligible, the primary study eye will be selected using a computer-generated random procedure before tissue results are available. Measurements and specimens from the fellow eye may be retained for separately identified exploratory analyses.
Participants will be classified according to the preoperative manifest refractive spherical equivalent of the primary study eye. High myopia will be defined as a spherical equivalent of -6.00 diopters or more myopic. Non-high myopia will be defined as a spherical equivalent of -0.50 diopters or more myopic but less myopic than -6.00 diopters.
Corneal lenticules removed during clinically indicated SMILE will be collected using a standardized handling and storage procedure. Each specimen will be linked to participant identifier, eye laterality, surgery date, and relevant surgical parameters. Structural and molecular analyses will investigate stromal remodeling and extracellular matrix characteristics. Specific assays and quantitative readouts will be documented in the protocol or a dated substudy analysis plan before the corresponding analyses.
Postoperative assessments will be scheduled at 1, 3, and 12 months after SMILE. Visual acuity, manifest refraction, intraocular pressure, corneal thickness, and Corvis ST measurements will be collected. Relevant medications, complications, and additional ocular procedures will be documented.
The primary analysis will compare baseline SP-A1 between the two refractive groups. Prespecified covariates will include age, sex, central corneal thickness, and intraocular pressure. Axial length will be examined as a continuous exposure in a separate supporting analysis.
Longitudinal models will account for repeated measurements. Analyses incorporating fellow eyes will additionally account for within-participant correlation. Estimates will be reported with 95% confidence intervals. Missing measurements, unavailable specimens, and reasons for loss to follow-up will be documented. Tissue analyses will use the corresponding-eye clinical measurements and will distinguish individual specimens from pooled samples.
Additional analyses of coded data or retained specimens will remain subject to participant consent and ethics approval. New confirmatory hypotheses will require dated analysis plans. Any exploratory prediction models will be evaluated offline and will not determine patient treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Myopia | – | Procedure: SMILEPatients undergoing clinically indicated SMILE whose primary study eye has a preoperative manifest refractive spherical equivalent of -6.00 diopters or more myopic. |
| Non-High Myopia | – | Procedure: SMILEPatients undergoing clinically indicated SMILE whose primary study eye has a preoperative manifest refractive spherical equivalent of -0.50 diopters or more myopic but less myopic than -6.00 diopters. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult patients attending the refractive surgery service at [institution, city, China] who are scheduled for clinically indicated SMILE will be screened. All patients meeting the eligibility criteria during the recruitment period will be invited to participate. The study population represents patients selected for SMILE and is not intended to represent all individuals with myopia.
Key inclusion criteria (6 listed)
- Age 18 years or older.
- Scheduled to undergo SMILE based on routine clinical assessment.
- At least one eligible eye with a manifest refractive spherical equivalent of -0.50 diopters or more myopic.
- Meets the institution's clinical criteria for SMILE, including refractive stability and contact lens discontinuation requirements.
- Able to provide written informed consent for clinical data collection, lenticule retention, and follow-up.
Key exclusion criteria (6 listed)
- Previous corneal refractive surgery or other surgery affecting corneal biomechanical assessment in the study eye.
- Known or suspected keratoconus, corneal ectasia, or clinically significant corneal scarring.
- Active ocular infection or inflammation.
- Diagnosed glaucoma or other ocular disease expected to materially affect interpretation of the study measurements.
- Systemic disease or medication use considered by the investigator to materially affect corneal wound healing or biomechanical assessment.
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 |
|---|---|---|
| SMILEClinically indicated SMILE performed according to routine clinical practice. Surgical selection and treatment parameters are not assigned by the research protocol. Removed lenticules will be retained with informed consent. | Procedure or surgery | High Myopia, Non-High Myopia |
Primary outcome
Preoperative Stiffness Parameter at First Applanation (SP-A1)
Time frame: Baseline, 1year
SP-A1 will be obtained from quality-accepted Corvis ST measurements of the primary study eye. The acquisition and repeat-measurement rules will be standardized before enrollment. The primary comparison will estimate the difference in baseline SP-A1 between the high-myopia and non-high-myopia groups.
4 secondary outcomes
Preoperative Integrated Inverse Radius
Time frame: Baseline, 1year
Change in SP-A1 From Baseline to 12 Months
Time frame: Baseline, 1year
Manifest Refractive Spherical Equivalent at 12 Months
Time frame: 1year
Early Postoperative Changes in SP-A1
Time frame: 1 and 3 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 4 Nov 2026.
- Individual participant dataSharing planned: Undecided. A decision regarding sharing of de-identified individual participant data will be made in accordance with participant consent, institutional policies, ethics approval, and applicable requirements. Any future sharing plan will specify the eligible datasets, access conditions, and supporting documentation.
Related trials for Myopia
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
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?
An observational study of Myopia, run by Tongji 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 6 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: opening soon, as of the sponsor's last update on 4 Nov 2026. 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 yuhao Shao, DR (18956775865, Shaoyh1998@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative Stiffness Parameter at First Applanation (SP-A1) (time frame: Baseline, 1year). 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 4 Nov 2026.