NCT02675751已完成不适用
A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-guided PRK Correction of Myopic Refractive Errors With the iDesign Advanced Wavescan Studio™ System and the Star S4 IR™ Excimer Laser System
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 167
- 主要终点
- The Percentage of Eyes Achieving the Target of Monocular Uncorrected Visual Acuity of 20/40 or Better
研究概览
简要总结
Prospective, multicenter, bilaterally-treated, open-label, non-randomized clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •NOTE: Enrollment open only to military personnel
- •Inclusion Criteria:
- •Signed informed consent and HIPAA authorization.
- •Refractive error, based on the iDesign displayed refraction must be myopia with or without astigmatism with sphere up to -8.00 D, and cylinder between 0.00 D and -4.00 D with maximum SE of -10.00 D.
- •Anticipated residual stromal bed thickness of at least 250 microns as calculated by the iDesign system.
- •Distance Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
- •BSCVA ≥2 lines (≥10 letters) better than distance Uncorrected Visual Acuity (UCVA).
- •Less than or equal to 0.75 D difference between cycloplegic and manifest refraction sphere.
- •Stable refractive error as defined by a change of ≤1.00 D in MRSE over at least a 12 month time period.
- •Any subject eye with a history of contact lens wear within the last 4 weeks must demonstrate refractive stability
- •Agreement between manifest refraction (adjusted for optical infinity) and iDesign System refraction chosen for treatment.
- •Willing and capable of complying with follow-up examinations for the duration of the study.
排除标准
- •Women who are pregnant, breast-feeding, or intend to become pregnant, or not using an adequate method of birth control.
- •Concurrent use of systemic (including inhaled) medications that may impair healing.
- •History of any of the following medical conditions, or any other condition that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or herpes simplex, endocrine disorders (including, but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis.
- •Subjects with a cardiac pacemaker, implanted defibrillator or other implanted electronic device.
- •History of prior intraocular or corneal surgery, active ophthalmic disease or abnormality, retinal detachment/repair, clinically significant lens opacity, clinical evidence of trauma, corneal opacity within the central 9 mm and visible on topography, at risk for developing strabismus, or with evidence of glaucoma or propensity for narrow angle glaucoma.
- •Evidence of keratoconus, corneal dystrophy or irregularity, or abnormal topography
- •Known sensitivity or inappropriate responsiveness to any of the medications used in this study.
- •If either eye does not meet all inclusion criteria
- •Desire to have monovision.
- •Participation in any other clinical study, with the exception of the fellow eye in this study.
研究组 & 干预措施
wavefront-guided PRK with iDesign
Experimental
wavefront-guided PRK for treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser
干预措施: STAR S4 IR laser with iDesign (Device)
结局指标
主要结局
The Percentage of Eyes Achieving the Target of Monocular Uncorrected Visual Acuity of 20/40 or Better
时间窗: 6 months
At 6 months, UCVA of 20/40 was achieved in 100% (324/324) of eyes monocularly.
次要结局
未报告次要终点
研究者
相似试验
进行中（未招募）
不适用
INTIBIA Pivotal StudyUrinary Bladder DiseasesUrologic DiseasesUrinary Incontinence, UrgeUrinary Bladder, OveractiveLower Urinary Tract SymptomsUrological ManifestationsNCT05250908Coloplast A/S208
Enrolling By Invitation
不适用
Clinical Study to Evaluate the Efficacy and Safety of Matrix Pro TreatmentSkin LaxityWrinkleSkin ConditionNCT06726122Candela Corporation60
进行中（未招募）
不适用
Clinical Study to Evaluate the Safety and Efficacy of Candela TechnologyHair ReductionAcneScarsBenign Cutaneous Vascular LesionsTattoo RemovalWrinkleSkin ConditionsNCT06202274Candela Corporation500
已完成
不适用
EndoRotor DEN (Direct Endoscopic Necrosectomy)TrialNecrotizing PancreatitisAcute PancreatitisAcute Pancreatic NecrosisNCT03694210Interscope, Inc.30
招募中
2 期
The Safety and Efficacy of Rapamycin on Communicating Hydrocephalus Secondary to Intraventricular HemorrhageCommunicating HydrocephalusSecondary Normal Pressure HydrocephalusPost Hemorrhagic HydrocephalusCerebral Intraventricular HemorrhageNCT06563817Beijing Tiantan Hospital53