NCT07127757招募中不适用
Clinical Evaluation of Visual Outcomes With the Wavelight Plus Excimer Laser in Normal and Dim Lighting
Laser Defined Vision1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年8月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- % of eyes with UDVA of 20/10, 20/12.5, 20/16 and 20/20 in photopic conditions at 3 months (monocular and binocular)
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 Low Luminance Questionnaire (LLQ-32) 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 —（Adult, Older 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 IRB approved Informed consent form
- •Willing and able to attend all scheduled study visits as required per protocol
- •Minimum of 18 years of age
- •Myopia up to -8.00 D, astigmatism up to -3.00 D, with SE more than -1.00D and up to -9.00D, based on Sightmap measured refraction
- •Best corrected photopic distance visual acuity of 20/20-2 or better (≤ 0.04 logMAR)
- •Mesopic pupil size ≥ 4.5mm
- •Less than 0.75 D manifest refraction spherical equivalent difference between Sightmap refraction and subjective manifest refraction
- •Stable refraction (within ± 0.50 D) as determined by manifest refraction spherical equivalent for a minimum of 12 months prior to surgery, verified by consecutive subjective refractions or medical records or prescription history
- •If currently wearing contact lenses:
- •Soft CTL wearers discontinue for minimum 3 days prior to first refraction
- •RGP or toric soft CTL wearers discontinue for ≥2 weeks prior to first refraction
排除标准
- •Subjects who are pregnant or nursing
- •Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study
- •Patients with flap complications
- •Systemic medications that may confound the outcome of the study or increase the risk to the subject.
- •Ocular condition (other than high myopia) that may predispose the subject to future complications, such as ectasia
- •History or evidence of active or inactive corneal disease (e.g., herpes simplex keratitis, herpes zoster keratitis, recurrent corneal erosion syndrome, corneal dystrophy)
- •Evidence of retinal vascular disease
- •Keratoconus or Keratoconus suspect
- •Glaucoma or glaucoma suspect by exam findings and/or family history
- •Previous intraocular or corneal surgery
- •Predicted residual stromal bed thickness < 250 μm
- •Intended to have monovision treatment
- •Participation in other current clinical trials
结局指标
主要结局
% of eyes with UDVA of 20/10, 20/12.5, 20/16 and 20/20 in photopic conditions at 3 months (monocular and binocular)
时间窗: 3 months postoperatively
% of eyes with UDVA of 20/10, 20/12.5, 20/16 and 20/20 in mesopic conditions at 3 months (monocular and binocular)
时间窗: 3 months postoperatively
% of eyes with CDVA of 20/10, 20/12.5, 20/16 and 20/20 in photopic conditions at 3 months (monocular and binocular)
时间窗: 3 months postoperatively
次要结局
- % of eyes with absolute MRSE within +/- 0.25, 0.50, 0.75, and 1.00D at 3 months(3 months postoperatively)
- Patient-Reported Outcomes with the modified PROWL Questionnaire and Low Luminance Questionnaire (LLQ-32) at 3 months(3 months postoperatively)
- % of eyes with lines gained/lost lines (post-up UDVA VS pre-op CDVA)(3 months postoperatively)
- % of eyes that achieved manifest refraction cylinder within +/- 0.25, 0.50, 0.75, and 1.00D at 3 months(3 months postoperatively)
- % of eyes that achieve UDVA equal to or better than preoperative CDVA(3 months postoperatively)
研究者
研究点 (1)
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