Patient Reported Outcomes on Vision Quality and Dry Eye Following Treatment With Wavelight LASIK

OVO LASIK + Lens4 个研究点分布在 1 个国家目标入组 300 人2024年11月1日

适应症Myopia

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Myopia
发起方: OVO LASIK + Lens
入组人数: 300
试验地点: 4
主要终点: Patient Satisfaction
状态: 已完成
最后更新: 上个月

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

This study is a multi-site, single-arm, ambispective, observational study of subject satisfaction, after successful bilateral LASIK surgery. Subjects will be assessed 12+ months post-operatively. Clinical evaluations will include administration of the OSDI, modified PROWL, and dry eye questionnaires.

注册库

clinicaltrials.gov

开始日期

2024年11月1日

结束日期

2025年2月14日

最后更新

上个月

研究类型

Observational

性别

All

研究者

发起方

OVO LASIK + Lens

责任方

Sponsor

入排标准

入选标准

•Wavefront Optimized or Phorcidies Planned Contoura LASIK for myopia or myopic astigmatism 12 to 15 months ago
•Age: 21 to 35 years of age at the time of surgery.
•Preoperative myopic sphere of -1.00 D to -8.00 D
•Preoperative regular astigmatism of 0.00 D to -3.00 D.
•Stable refraction preoperatively defined as \< 0.5 D of change over at least 1 year.
•Refractive target of bilateral emmetropia.

排除标准

•Corneal ectatic disorders.
•Patients with a calculated residual stromal depth of \< 300 um.
•Pre-existing retinal or corneal pathology, or irregular astigmatism.
•Pre-existing autoimmune diseases, dry eye, glaucoma, diabetes, etc.
•Previous corneal surgeries prior to LASIK.
•LASIK enhancements.

结局指标

主要结局

Patient Satisfaction

时间窗: 12 months postoperatively

Percentage of subjects satisfied (Completely Satisfied or Very Satisfied) with vision after Wavelight LASIK based on a modified PROWL Questionnaire (Question #1 only).

次要结局

OSDI Questionnaire(12 months postoperatively)
PROWL Questionnaire(12 months postoperatively)
Percentage of Subjects Using Artificial Tears or Prescription Dry Eye Medication.(12 months postoperatively)