MyopiaSMILE LASEKNCT07260786
the Correlation Between Visual Quality After SMILE and LASEK in Patients With Moderate to Low Myopia
An observational study of Myopia, run by yuhao shao at 1 site in China.
Trial summary
1. Study the changes in subjective visual quality, contrast sensitivity, and total ocular aberrations of patients with low-to-moderate myopia after SMILE and LASEK surgeries at different age groups; 2. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Myopia
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: People with mild to moderate myopia who have undergone SMILE or LASEK surgeries
Who may be able to join
- Patients with refractive errors who were scheduled to undergo SMILE surgery and LASEK surgery were selected. The preoperative equivalent spherical diopter (SE) of the affected eye was less than -6D. The surgical plan was based on voluntary principle and was divided into the SMILE group and the LASEK group. Each surgical group was further divided according to age into groups of ≤ 20 years old, 21-30 years old, 31-40 years old, and ≥ 41 years old. Each group consisted of 35 patients. There were no significant differences in gender, equivalent spherical diopter (SE), optical zone, and preoperative best corrected visual acuity among the groups.
Who cannot join
- The nearsightedness has increased by more than 1D in the past two years. Severe dry eye syndrome, keratoconus, glaucoma, history of eye surgery, severe systemic connective tissue or autoimmune diseases
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
About this study
Official title: A Study on the Correlation Between Visual Quality After SMILE and LASEK Procedures and the Visual Conduction Pathways in Patients With Moderate to Low Myopia
- Study the changes in subjective visual quality, contrast sensitivity, and total ocular aberrations of patients with low-to-moderate myopia after SMILE and LASEK surgeries at different age groups;
- Evaluate the effects of SMILE and LASEK surgeries on the visual conduction pathway PVEP in patients with refractive errors of different age groups;
- Clarify the correlations between subjective and objective visual quality after SMILE and LASEK surgeries in patients with refractive errors of different age groups and PVEP.
- Conditions
- Myopia
- Keywords
- myopia, SMILE, LASEK, VEP, CS
- Medical subject headings
- Myopia
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 |
|---|---|---|
| SMILE | undergoing SMILE | |
| LASEK | undergoing SMILE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast sensitivity
Under sufficient correction conditions, dark adaptation lasted for 10 minutes. Using the CSV-1000 contrast sensitivity tester at a distance of 3 meters, under the conditions of bright vision (85 cd/m ²), bright glare (135 lx), dark vision (3 cd/m ²), and dark glare (28 lx) respectively, Test the highest CS level that can be distinguished at 3, 6, 12 and 18 c/d spatial frequencies one by one. At each spatial frequency, the examinee needs to point out the bar grid sight in the upper and lower two circular sight targets and report the direction of the bar grid. After the result is correct, gradually reduce the bar grid contrast until the examinee can no longer recognize it. The inverse of the lowest recognizable contrast at this time is the contrast sensitivity. Record in logarithmic units according to the grade value conversion table.
Measured: Before the operation, 1 week after the operation, 1 month after the operation, 3 months after the operation, 6 months after the operation
VEP
The VEP examination was repeated forN75 and P100. N75 latency and P100 amplitude and latency scores were calculated on the average waveform. It required manual definition of the lowest negative peak (N75) before P100 peak.
Amplitude was scored as the difference between these two points and latency was scored as the time difference between N75 lowest peak or P100 peak and stimulus onset.
Measured: Before the operation, 1 week after the operation, 1 month after the operation, 3 months after the operation, 6 months after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Jan 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 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.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- yuhao shao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, yuhao shao, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260786
- Sponsor's protocol ID
- 20251022VEP
- Other IDs
- YNCR2C004
- Acronym
- SMILE LASEK
- Status last verified
- Nov 2025
- First submitted
- 21 Nov 2025
- Last updated
- 3 Dec 2025
- 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 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Correlation Between Visual Quality After SMILE and LASEK Procedures and the Visual Conduction Pathways in Patients With Moderate to Low Myopia
- ClinicalTrials.gov ID
- NCT07260786
- Acronym / sponsor ID
- SMILE LASEK / 20251022VEP
- Conditions
- Myopia
- Keywords
- myopia, SMILE, LASEK, VEP, CS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- yuhao shaoUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 3 Dec 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.
- Study the changes in subjective visual quality, contrast sensitivity, and total ocular aberrations of patients with low-to-moderate myopia after SMILE and LASEK surgeries at different age groups;
- Evaluate the effects of SMILE and LASEK surgeries on the visual conduction pathway PVEP in patients with refractive errors of different age groups;
- Clarify the correlations between subjective and objective visual quality after SMILE and LASEK surgeries in patients with refractive errors of different age groups and PVEP.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMILE | – | –undergoing SMILE |
| LASEK | – | –undergoing SMILE |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- People with mild to moderate myopia who have undergone SMILE or LASEK surgeries
Key inclusion criteria (1 listed)
- Patients with refractive errors who were scheduled to undergo SMILE surgery and LASEK surgery were selected. The preoperative equivalent spherical diopter (SE) of the affected eye was less than -6D. The surgical plan was based on voluntary principle and was divided into the SMILE group and the LASEK group. Each surgical group was further divided according to age into groups of ≤ 20 years old, 21-30 years old, 31-40 years old, and ≥ 41 years old. Each group consisted of 35 patients. There were no significant differences in gender, equivalent spherical diopter (SE), optical zone, and preoperative best corrected visual acuity among the groups.
Key exclusion criteria (1 listed)
- The nearsightedness has increased by more than 1D in the past two years. Severe dry eye syndrome, keratoconus, glaucoma, history of eye surgery, severe systemic connective tissue or autoimmune diseases
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
Contrast sensitivity
Time frame: Before the operation, 1 week after the operation, 1 month after the operation, 3 months after the operation, 6 months after the operation
Under sufficient correction conditions, dark adaptation lasted for 10 minutes. Using the CSV-1000 contrast sensitivity tester at a distance of 3 meters, under the conditions of bright vision (85 cd/m ²), bright glare (135 lx), dark vision (3 cd/m ²), and dark glare (28 lx) respectively, Test the highest CS level that can be distinguished at 3, 6, 12 and 18 c/d spatial frequencies one by one. At each spatial frequency, the examinee needs to point out the bar grid sight in the upper and lower two circular sight targets and report the direction of the bar grid. After the result is correct, gradually reduce the bar grid contrast until the examinee can no longer recognize it. The inverse of the lowest recognizable contrast at this time is the contrast sensitivity. Record in logarithmic units according to the grade value conversion table.
VEP
Time frame: Before the operation, 1 week after the operation, 1 month after the operation, 3 months after the operation, 6 months after the operation
The VEP examination was repeated forN75 and P100. N75 latency and P100 amplitude and latency scores were calculated on the average waveform. It required manual definition of the lowest negative peak (N75) before P100 peak. Amplitude was scored as the difference between these two points and latency was scored as the time difference between N75 lowest peak or P100 peak and stimulus onset.
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 3 Dec 2025.
- 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, run by yuhao shao 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 1 inclusion and 1 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 3 Dec 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?
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?
Contrast sensitivity (time frame: Before the operation, 1 week after the operation, 1 month after the operation, 3 months after the operation, 6 months after the operation). The study lists 2 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 3 Dec 2025.