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

NCT06898164 | Completed

• 3 other identifiers: 2025ALYJXYS-B-009202240131
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Visual Quality; Axial Length; High Myopia

Keywords

Axial length; High myopia; SMILE; Higher-order aberration; visual quality

Outcome Measures

Primary Outcomes (1)

• Subjective visual quality

  The quality of vision (QOV) questionnaire consists of (i) symptom frequency, (ii) severity, and (iii) bothersomeness for (a) glare, (b) halo, (c) starbursts, (d) hazy vision, (e) blurred vision, (f) distortion, (g) multiple images, (h) visual fluctuations, (i) difficulty focusing, and (j) difficulty judging distance or depth perception. Respondents use a scale of 0 to 3, where zero (0) denotes "none," one (1) "a little," two (2) "quite a bit," and three (3) "very much." Furthermore, on a scale from 0 to 10, patients were asked to provide Likert ratings for "daytime" and "nighttime" quality of vision (0 denoting the poorest vision, while 10 indicating the best vision)

  12 months

Secondary Outcomes (1)

• Refractive results

  12 months

Other Outcomes (1)

• Ocular high-order aberrations

  12 months

Study Arms (3)

AL < 26 mm

high myopic patients with axial lengths \< 26 mm

Other: This study does not involve any interventions

26 mm ≤ AL < 27 mm

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

Other: This study does not involve any interventions

AL ≥ 27 mm

high myopic patients with axial lengths ≥ 27 mm

Other: This study does not involve any interventions

Interventions

This study does not involve any interventions OTHER

This study does not involve any interventions

26 mm ≤ AL < 27 mm; AL < 26 mm; AL ≥ 27 mm

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

A total of 113 high myopic patients (202 eyes) of Shanghai's Tenth People's Hospital were enroled in this prospective, non-randomized study conducted from July 2021 to September 2023.

You may qualify if:

• 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.

You may not qualify if:

• a history of moderate to severe dry eye as well as any ocular or systemic disease.

Sponsors & Collaborators

• yuhao shao: lead
• Shanghai 10th People's Hospital: collaborator

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 27, 2025
• Study Start: July 1, 2021
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)