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| ID | Type | Description | Link |
|---|---|---|---|
| YJXYS-B-009 | Other Grant/Funding Number | Shanghai 10th People's Hospital | |
| 202240131 | Other Grant/Funding Number | Shanghai 10th People's Hospital |
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| Name | Class |
|---|---|
| Shanghai 10th People's Hospital | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AL < 26 mm | high myopic patients with axial lengths < 26 mm |
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| 26 mm ≤ AL < 27 mm | high myopic patients with 26 mm ≤ axial lengths < 27 mm |
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| AL ≥ 27 mm | high myopic patients with axial lengths ≥ 27 mm |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| This study does not involve any interventions | Other | This study does not involve any interventions |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Refractive results | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular high-order aberrations | Corneal 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) |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Tenth People's Hospital | Shanghai | Shanghai Municipality | 200000 | China |
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| 12 months |