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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06898164
Enrollment
113
Registered
2025-03-27
Start date
2021-07-01
Completion date
2024-09-01
Last updated
2025-03-27

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

Conditions

Axial Length, High Myopia, Visual Quality

Keywords

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

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.

Interventions

This study does not involve any interventions

Sponsors

Shanghai 10th People's Hospital
CollaboratorOTHER
yuhao shao
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Subjective visual quality12 monthsThe 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

MeasureTime frameDescription
Refractive results12 monthsThe 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.

Other

MeasureTime frameDescription
Ocular high-order aberrations12 monthsCorneal aberration measurements were performed using a Scheimpflug tomography system (Pentacam; Oculus GmbH, Wetzlar, Germany). Images of the highest quality (designated as OK) were selected for analysis. The coefficients for a standardized diameter of 8 mm were examined, followed by an assessment of the clinical significance of total higher-order aberrations (HOA, mm), spherical aberration (Z4, 0, mm), horizontal coma (Z3, 1, mm), vertical coma (Z3, -1, mm), horizontal trefoil (Z3, 3, mm), and oblique trefoil (Z3, -3, mm)

Countries

China

Outcome results

None listed

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