Small-incision Lenticule Extraction (SMILE) SurgeryNCT06806085
Analysis of Influencing Factors of High-Order Aberrations of SMILE With Lenticule Retained
An observational study of Small-incision Lenticule Extraction (SMILE) Surgery and Corneal Higher-order Wavefront Aberrations, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
Trial summary
Analysis of Influencing Factors of High-Order Aberrations of SMILE with Lenticule Retained Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Small-incision Lenticule Extraction (SMILE) Surgery, Corneal Higher-order Wavefront Aberrations, Residual Lenticule
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2024to 31 Oct 2026
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Each subject must have complete surgical video recordings and medical records.
Who may be able to join
- Age ≥ 18 years, gender unrestricted;
- Equivalent spherical refraction ≤ -10.0D, corrected distance visual acuity ≥ 1.0, myopia stable for ≥ 2 years, and no contact lens wear for at least 2 weeks;
- The patient voluntarily participates in this study, signs the informed consent form, and agrees to follow up according to the study plan;
- Predicted postoperative residual corneal stromal thickness ≥ 280 micrometers.
Who cannot join
- Subclinical keratoconus, keratoconus, moderate to severe corneal opacities or scars, and other ocular conditions;
- Diabetes, keloid-prone constitution, autoimmune and connective tissue diseases, etc.;
- Severe mental disorders such as generalized anxiety disorder, panic disorder, depression, schizophrenia, and bipolar disorder; inability to cooperate with physicians;
- Refusal to participate in the study.
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
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000
Jian J Xiong, doctor, +8618170906556, 894040417@qq.com
Fu Gui, doctor, +8613879101919, 564436578@qq.com
About this study
Official title: Analysis of Influencing Factors of High-Order Aberrations of Small Incision Lenticule Extraction With Lenticule Retained
Analysis of Influencing Factors of High-Order Aberrations of SMILE with Lenticule Retained
Read the detailed description
Wavefront analysis and other objective methods are the mainstream approaches for assessing visual quality after refractive surgery, with high-order aberrations being the main observation indicators. Some studies have explored the correlation between various complications after SMILE surgery and high-order aberrations. However, research on lenticule retained after surgery has mainly focused on clinical management and case reports of overt lenticule retained, while there is a lack of high-quality observational studies on the population with covert lenticule retained (periphery residual lenticule) to serve as evidence. This often puts clinicians in a dilemma of whether to perform another surgery to remove the remnants. In summary, although research on lenticule retained after SMILE surgery is gradually increasing, systematic studies on their relationship with higher-order aberrations are still insufficient. This study aims to fill the gap in existing research by comparing and analyzing high-order aberrations between patients with and without periphery residual lenticule, providing a more comprehensive assessment of postoperative visual quality. This will offer important theoretical basis and practical guidance for improving SMILE surgical techniques and optimizing postoperative management.
- Conditions
- Small-incision Lenticule Extraction (SMILE) Surgery, Corneal Higher-order Wavefront Aberrations, Residual Lenticule
- Keywords
- Residual Lenticule, Corneal Higher-order Wavefront Aberrations, Small-incision Lenticule Extraction
- Medical subject headings
- Smiling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| lenticule retained group | Not described | |
| Non-lenticule retained group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Δ Higher-order Aberration
Preoperative and postoperative Higher-order aberration difference obtained from wavefront aberrations map of corneal topography in Pentacam measurement.
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start31 Oct 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small-incision Lenticule Extraction (SMILE) SurgeryStudies 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
- Cross-sectional
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Xiong, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806085
- Sponsor's protocol ID
- [2024] NO.(138)
- Status last verified
- Oct 2025
- First submitted
- 26 Jan 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Influencing Factors of High-Order Aberrations of Small Incision Lenticule Extraction With Lenticule Retained
- ClinicalTrials.gov ID
- NCT06806085
- Acronym / sponsor ID
- [2024] NO.(138)
- Conditions
- Small-incision Lenticule Extraction (SMILE) Surgery, Corneal Higher-order Wavefront Aberrations, Residual Lenticule
- Keywords
- Residual Lenticule, Corneal Higher-order Wavefront Aberrations, Small-incision Lenticule Extraction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 3 Feb 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.
Analysis of Influencing Factors of High-Order Aberrations of SMILE with Lenticule Retained
Detailed description
Wavefront analysis and other objective methods are the mainstream approaches for assessing visual quality after refractive surgery, with high-order aberrations being the main observation indicators. Some studies have explored the correlation between various complications after SMILE surgery and high-order aberrations. However, research on lenticule retained after surgery has mainly focused on clinical management and case reports of overt lenticule retained, while there is a lack of high-quality observational studies on the population with covert lenticule retained (periphery residual lenticule) to serve as evidence. This often puts clinicians in a dilemma of whether to perform another surgery to remove the remnants. In summary, although research on lenticule retained after SMILE surgery is gradually increasing, systematic studies on their relationship with higher-order aberrations are still insufficient. This study aims to fill the gap in existing research by comparing and analyzing high-order aberrations between patients with and without periphery residual lenticule, providing a more comprehensive assessment of postoperative visual quality. This will offer important theoretical basis and practical guidance for improving SMILE surgical techniques and optimizing postoperative management.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lenticule retained group | – | – |
| Non-lenticule retained group | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Each subject must have complete surgical video recordings and medical records.
Key inclusion criteria (4 listed)
- Age ≥ 18 years, gender unrestricted;
- Equivalent spherical refraction ≤ -10.0D, corrected distance visual acuity ≥ 1.0, myopia stable for ≥ 2 years, and no contact lens wear for at least 2 weeks;
- The patient voluntarily participates in this study, signs the informed consent form, and agrees to follow up according to the study plan;
- Predicted postoperative residual corneal stromal thickness ≥ 280 micrometers.
Key exclusion criteria (4 listed)
- Subclinical keratoconus, keratoconus, moderate to severe corneal opacities or scars, and other ocular conditions;
- Diabetes, keloid-prone constitution, autoimmune and connective tissue diseases, etc.;
- Severe mental disorders such as generalized anxiety disorder, panic disorder, depression, schizophrenia, and bipolar disorder; inability to cooperate with physicians;
- Refusal to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Δ Higher-order Aberration
Time frame: Day 90
Preoperative and postoperative Higher-order aberration difference obtained from wavefront aberrations map of corneal topography in Pentacam measurement.
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 22 Apr 2026.
- 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.
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 Small-incision Lenticule Extraction (SMILE) Surgery and Corneal Higher-order Wavefront Aberrations, 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 4 inclusion and 4 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 22 Apr 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 Jian Xiong, doctor (+8618170906556, 894040417@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Δ Higher-order Aberration (time frame: Day 90). 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 22 Apr 2026.