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the Correlation Between Visual Quality After SMILE and LASEK in Patients With Moderate to Low Myopia

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07260786
Acronym
SMILE LASEK
Enrollment
100
Registered
2025-12-03
Start date
2022-01-01
Completion date
2024-12-31
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Keywords

myopia, SMILE, LASEK, VEP, CS

Brief 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. Evaluate the effects of SMILE and LASEK surgeries on the visual conduction pathway PVEP in patients with refractive errors of different age groups; 3. 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.

Interventions

None listed

Sponsors

yuhao shao
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Contrast sensitivityBefore the operation, 1 week after the operation, 1 month after the operation, 3 months after the operation, 6 months after the operationUnder 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.
VEPBefore the operation, 1 week after the operation, 1 month after the operation, 3 months after the operation, 6 months after the operationThe 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026