A Randomized Evaluation of Clinical Outcomes Following Bilateral Implantation of EVO+ ICL Lenses or Bilateral Wavefront-Optimized LASIK (EVOlve)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 10
- 主要终点
- Visual Acuity
研究概览
简要总结
Evaluating outcomes after bilateral implantation of ICLs or bilateral LASIK as treatment options for the correction or reduction of myopia with or without astigmatism.
详细描述
A randomized evaluation of clinical outcomes following bilateral implantation of EVO+ Visian™ Implantable Collamer™ Lenses or bilateral Wavefront-optimized LASIK as treatment options for the correction or reduction of myopia with or without astigmatism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preoperatively the Investigator will evaluate each study subject and refer to the directions for use for EVO+ ICL and Wavefront-Optimized LASIK to confirm the subject's suitability to proceed with bilateral EVO+ ICL Implantation or bilateral Wavefront-optimized LASIK in accordance with the Investigator's standard of care for each procedure. To ensure similar characteristics across study subjects, the Investigator will also adhere to the following criteria for each group:
- •Subjects ages 21 to 45 years old.
- •Stable refractive error for at least one year (≤ 0.50 D change in refraction) or stability as determined by the Investigator.
- •Myopia or myopia with astigmatism with spherical equivalent ranging from -3.00 D to ≤ -8.00 D (in the spectacle plane) and cylinder in the range of 0.00 D to 4.00 D (in the spectacle plane).
- •Corrected distance visual acuity (CDVA) of 20/20 or better in each eye.
- •Difference between cycloplegic refraction spherical equivalent (CRSE) and manifest refraction spherical equivalent (MRSE) of ≤0.75 D.
- •Subjects must be able and willing to return for scheduled follow-up examinations after surgery.
- •Subjects must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF) and provide authorization as appropriate for local privacy regulations.
排除标准
- •1. Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study or has another condition with associated fluctuation of hormones that could lead to refractive changes.
- •2. Dry eye syndrome that is unable to be controlled with ocular lubricant(s) or medication(s) and which may confound study outcomes in the opinion of the Investigator.
- •3. Serious acute, chronic, or systemic, non-ophthalmic disease or illness that would increase the operative risk, confound the outcome(s) of the study or which may preclude study completion (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, uncontrolled diabetes, etc.), in the opinion of the Investigator.
- •4. Ocular condition (other than high myopia) that may predispose the subject to future complications, in the opinion of the Investigator. For example:
- •Pigment dispersion,
- •History or clinical signs of iritis/uveitis,
- •History of previous ocular surgery,
- •Monocular subjects,
- •History or evidence of active or inactive corneal disease (e.g., herpes simplex keratitis, herpes zoster keratitis, recurrent corneal erosion syndrome, corneal dystrophy, etc.),
- •Evidence of retinal vascular disease,
- •Keratoconus or keratoconus suspect,
- •Glaucoma or glaucoma suspect by exam findings,
- •Ocular surface disease other than controlled dry eye syndrome.
- •Subjects who do not qualify for both study arms:
- •Bilateral Wavefront Optimized LASIK
- •Bilateral EVO+ ICL implantation
- •6. Subjects who, in the judgment of the Investigator, present any emotional, physiologic, or anatomical condition which may preclude participation in this study or provide an inappropriate landscape for the intended study treatment.
- •7. Participation in another clinical trial involving ocular procedures within the last 6-months.
- •8. Other conditions or assessment that causes the subject to not be an acceptable candidate for treatment or study participation as clinically assessed and documented by the Investigator.
研究组 & 干预措施
Laser-assisted in Situ Keratomileusis
LASIK-Wavefront Optimized
干预措施: Implantable Collamer Lens placement (Device)
Implantable Collamer Lens placement
EVO ICL
干预措施: Laser-assisted in Situ Keratomileusis (Device)
结局指标
主要结局
Visual Acuity
时间窗: 1 month
Uncorrected distance visual acuity and Corrected distance visual acuity
Manifest refractive spherical equivalent
时间窗: 1 month
Manifest refraction spherical equivalent (MRSE) is a measurement used in eye care to determine the overall refractive error of the eye, taking into account both nearsightedness or farsightedness (spherical component) and astigmatism (cylindrical component). It's calculated by adding the sphere power and half of the cylinder power
Abberometry (Higher Order Abberations and Corneal Performance Index)
时间窗: 1 month
Aberrometry is a technique used to measure the optical aberrations of the eye, including both lower-order aberrations (LOAs) and higher-order aberrations (HOAs). LOAs are the standard refractive errors, such as nearsightedness, farsightedness, and astigmatism, which can be corrected with glasses or contact lenses. HOAs, on the other hand, are more complex aberrations that affect the quality of vision, even if the LOAs are corrected. HOAs are caused by irregularities in the shape of the cornea or lens. They can cause a variety of visual symptoms, including blurry vision, glare, halos, and difficulty seeing at night
Objective Scatter Index
时间窗: 1 month
The Objective Scatter Index (OSI) is a measurement used in ophthalmology to assess the quality of the eye's optical media, particularly the cornea and lens. It quantifies the amount of light scatter within the eye, which can affect visual clarity and contrast sensitivity.
Contrast Sensitivity
时间窗: 1 month
Contrast sensitivity is the ability to distinguish between objects with varying degrees of contrast, especially in situations of low light or when objects have subtle differences in shading.
Tear Film Stability
时间窗: 1 month
Tear film stability refers to the ability of the tear film, a thin layer of fluid that covers the surface of the eye, to remain intact and maintain a smooth, even surface. This is essential for clear vision and healthy ocular surface.
Ocular Adverse Events in treated eyes/safety
时间窗: 1 month
Ocular adverse events (OAEs) are side effects that can occur in the eye after receiving a treatment, such as medication, surgery, or radiation therapy. These events can range from mild and temporary to severe and permanent.
Subjective Questionnaires and Open-Ended Questions
时间窗: 1 month
Subjective questionnaires and open-ended questions are two common methods used in research to gather qualitative data. They allow researchers to delve deeper into participants' thoughts, feelings, and experiences, providing rich insights that quantitative methods may not capture.
次要结局
未报告次要终点