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

NCT ID: NCT07260786

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Myopia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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SMILE

undergoing SMILE

No interventions assigned to this group

LASEK

undergoing SMILE

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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yuhao shao

OTHER

Sponsor Role lead

Responsible Party

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yuhao shao

DR

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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YNCR2C004

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20251022VEP

Identifier Type: -

Identifier Source: org_study_id

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