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

Completed

• Conditions: Visual Quality; Axial Length; High Myopia

• Registration Number: NCT06898164
• Lead Sponsor: yuhao shao

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).

Detailed Description

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.

Study Timeline

• Study Start: 2021-07-01
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01
• Status Verified: 2025-03
• Study First Submitted: 2025-03-13
• Study First Submitted QC: 2025-03-20
• Last Update Submitted: 2025-03-20
• Study First Posted: 2025-03-27
• Last Update Posted: 2025-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subjective visual quality	12 months	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)

Secondary Outcome Measures

Name	Time	Method
Refractive results	12 months	The uncorrected distance visual acuity (UDVA, logMAR), corrected distance visual acuity (CDVA, logMAR), subjective refraction (Diopter), and intraocular pressure (mmHg) were evaluated prior to and 1 year after SMILE.

Trial Locations

Locations (1)

Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, Shanghai, China