NCT07087665已完成不适用
Patient Satisfaction, Quality of Vision, and Quality of Life Following Treatment With WaveLight Plus LASIK
OVO LASIK + Lens2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7月24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
- 60
- 试验地点
- 2
- 主要终点
- Percentage of subjects satisfied (Completely Satisfied or Very Satisfied) with vision after Wavelight Plus LASIK based on an adapted PROWL Questionnaire (Question #1 only).
研究概览
简要总结
This study is a single-site, single-arm, prospective, observational study of subject satisfaction, quality of vision, and quality of life after bilateral LASIK surgery. Subjects will be assessed 6 months post-operatively. Clinical evaluations will include refractive outcomes, visual acuity, and administration of the adapted PROWL, QIRC, and OSDI questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 37 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be able to understand and sign an approved consent form.
- •Willing and able to comply with scheduled visits and other study procedures.
- •Age: 18 to 37
- •Myopia with or without astigmatism and MRSE within the range indications for wavelight plus (myopia up to -8 D, astigmatism up to -3.0 D, S.E. more than -1.00 and up to -9.00D)
- •Pre-surgery BCDVA of 20/20 (0.00 logMAR) or better in each eye.
- •Stable refraction (within ± 0.50 D) as determined by manifest refraction spherical equivalent for a minimum of 12 months prior to surgery.
- •Refractive target of bilateral emmetropia
- •Mesopic pupil size ≥ 4.5mm
- •Less than 0.75 D spherical equivalent difference between Sightmap measured refraction SE and the subjective manifest refraction (MRSE)
排除标准
- •Subjects with a history of previous ocular surgery.
- •Subjects with topographic evidence of keratoconus or ectasia.
- •Pre-existing retinal or corneal pathology Subjects with autoimmune diseases.
- •Subjects who are pregnant or nursing.
- •Systemic disease likely to affect wound healing, such as diabetes and severe atopy.
- •Any ocular disease (including uncontrolled dry eye) in which the investigator's opinion would affect the outcome of refractive surgery.
- •Patients with a calculated residual stromal depth <250 µm would be excluded from the study.
结局指标
主要结局
Percentage of subjects satisfied (Completely Satisfied or Very Satisfied) with vision after Wavelight Plus LASIK based on an adapted PROWL Questionnaire (Question #1 only).
时间窗: 6 months postoperatively
次要结局
- Remaining Vision quality and quality of life during daily tasks using the adapted PROWL(6 months postoperatively)
- The percentage of eyes at each monocular visual acuity (VA) level (uncorrected 20/10, 20/12.5, 20/16, 20/20, 20/25).(6 months postoperatively)
- The percentage of subjects at each binocular visual acuity (VA) level (uncorrected 20/10, 20/12.5, 20/16, 20/20, 20/25).(6 months postoperatively)
研究者
研究点 (2)
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