The Influence of Axial Length on Visual Quality Following SMILE Surgery in Patients with High Myopia

NCT ID: NCT06898164

Last Updated: 2025-03-27

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

113 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2024-09-01

Brief Summary

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This retrospective study aimed to investigate the subjective and objective visual outcomes following Small Incision Lenticule Extraction (SMILE) surgery in high myopic patients with varying axial lengths (AL).

Detailed Description

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The study enrolled 113 highly myopic patients (202 eyes) who underwent SMILE surgery at Shanghai's Tenth People's Hospital. Patients were classified into three groups based on the axial length before surgery: Group A (AL \< 26 mm, 62 eyes), Group B (26 mm ≤ AL \< 27 mm, 88 eyes), and Group C (AL ≥ 27 mm, 52 eyes). Preoperative and postoperative evaluations included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), equivalent spherical error(SE), and corneal high order aberration. Subjective visual quality was assessed using the Quality of Vision (QoV) questionnaire.

Conditions

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Visual Quality Axial Length High Myopia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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AL < 26 mm

high myopic patients with axial lengths \< 26 mm

This study does not involve any interventions

Intervention Type OTHER

This study does not involve any interventions

26 mm ≤ AL < 27 mm

high myopic patients with 26 mm ≤ axial lengths \< 27 mm

This study does not involve any interventions

Intervention Type OTHER

This study does not involve any interventions

AL ≥ 27 mm

high myopic patients with axial lengths ≥ 27 mm

This study does not involve any interventions

Intervention Type OTHER

This study does not involve any interventions

Interventions

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This study does not involve any interventions

This study does not involve any interventions

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* manifest refraction spherical equivalent refraction exceeding -6.00D;
* stable myopia for a duration of at least 2 years;
* corrected distance visual acuity of at least 20/25;
* annual myopic spherical equivalent increment less than - 0.50 D.

Exclusion Criteria

* a history of moderate to severe dry eye as well as any ocular or systemic disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai 10th People's Hospital

OTHER

Sponsor Role collaborator

yuhao shao

OTHER

Sponsor Role lead

Responsible Party

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yuhao shao

MD

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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YJXYS-B-009

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

202240131

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2025AL

Identifier Type: -

Identifier Source: org_study_id

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