NCT07084844招募中不适用
Patient Reported Outcomes and Satisfaction With Wavelight Plus LASIK
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Mean score of satisfaction with uncorrected vision after wavelight plus LASIK based on PROWL-SS Questionnaire preoperative vs postoperative (question #1 [Q1] 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 up to 3 months post-operatively. Clinical evaluations will include refractive outcomes, visual acuity, and administration of the adapted PROWL and the Quality-of-Life Impact of Refractive Correction (QIRC) Questionnaire.
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 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 18 and 39
- •Meet the standard care requirements for LASIK
- •Spherical equivalent (SE) more than -1.00D and up to -9.00 diopters
- •Myopia ≤ -8.00 sphere (in minus cylinder format) and up to -3.00D astigmatism
- •SE difference between the manifest refraction and the Sightmap measured SE being less than 0.75D
- •Minimum residual stromal bed thickness of 250 µm
- •If currently wearing contact lenses:
- •Soft CTL wearers discontinue for minimum 3 days
- •RGP CTL wearers discontinue for 1 month per decade of wear
- •Stable refraction (2 consecutive manifest refractions within 0.25 SE)
- •Stable K readings (2 consecutive K readings in 2 consecutive visits)
- •Willing and able to complete all post-operative visits
- •Pre-surgery BCDVA of 20/20 (0.00 logMAR) or better in each eye.Mesopic pupil size ≥ 4.5mm
排除标准
- •Subjects with any prior ocular surgery
- •Subjects with topographic evidence of keratoconus, or ectasia
- •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 un-controlled dry eye) which in the investigator's opinion would affect the outcome of refractive surgery
结局指标
主要结局
Mean score of satisfaction with uncorrected vision after wavelight plus LASIK based on PROWL-SS Questionnaire preoperative vs postoperative (question #1 [Q1] only).
时间窗: 3 months postoperative
次要结局
- PROWL-SS Questionnaire(3 months postoperative)
- OSDI Score(3 months postoperative)
- Uncorrected distance visual acuity(3 months postoperative)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Vivity Insight: A Study of Patient Satisfaction and Visual PerformanceCataractNCT04495049Research Insight LLC60
已完成
不适用
Patient Reported Outcomes With WaveLight LASIKMyopiaNCT06668909OVO LASIK + Lens300
已完成
不适用
Investigation of patient satisfaction and efficacy of Dovobet Gel in psoriasis patients with poor adherence (INSPADES Study)Plaque PsoriasisjRCTs03118004950
已完成
不适用
Long Term Observation of Patient Satisfaction Post INTRACOR Treatment Based on Patient Perception and Diagnostic DataPresbyopiaNCT01164358Technolas Perfect Vision GmbH105
Unknown
不适用
Patient Satisfaction and Tear Osmolarity With the Use of Blink Tears, Blink Gel Tears and Systane BalanceDry EyeNCT01589640Ophthalmic Consultants of Connecticut60