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临床试验/NCT06898164
NCT06898164已完成不适用

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

yuhao shao1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
113
试验地点
1
主要终点
Subjective visual quality

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

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

结局指标

主要结局

Subjective visual quality

时间窗: 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)

次要结局

  • Refractive results(12 months)

研究者

发起方
yuhao shao
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

yuhao shao

MD

Tongji University

研究点 (1)

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