Euclid Phoenix Lens Design Trial Phase 1
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 10
- 主要终点
- First fit success rate
研究概览
简要总结
The "first fit" success rate of the current Euclid orthokeratology "MAX" lens design will be compared to that of the new Euclid orthokeratology MAX "Phoenix" lens design in 30 children.
详细描述
The primary objective of this trial is to provide an assessment of the "first fit" success of the Euclid orthokeratology "Phoenix" lens design versus its current "MAX" lens design when used by practitioners with moderate experience with fitting Euclid MAX orthokeratology lenses.
The hypothesis to be tested is that the "first fit" success of the redesign Euclid MAX "Phoenix" lens design is greater than that of the current MAX lens design.
The primary outcome variable is the percentage of participants successfully fit with the first lenses empirically ordered for the existing MAX lens design versus a modified MAX lens ("Phoenix") design.
This clinical investigation will be a prospective, randomized, double-masked two-arm non-crossover trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be of legal age or, if under legal age have written consent of their parent or guardian to participate.
- •Sign written Informed Consent (and the California Bill of Rights, if applicable).
- •Ages 6-18 (inclusive) and able to understand and assent to participation
- •Have need of optical correction for myopia, from -1.00 to -5.00 dioptcrs (D).
- •Have a refractive astigmatism of less than -1.50 D.
- •Have a minimum Best Spectacle Corrected Visual Acuity (BSCVA) of 20/40 or better.
- •Have reasonable expectations of improvement in visual acuity with the Euclid Orthokeratology Lens of 20/40 or better after overnight wear without corrective aids.
- •Be at least 18 years old to give informed consent.
- •Not a current or former wearer of orthokeratology lenses
- •Not a current wearer of soft contact lenses
- •Have acceptable or optimal fit with study lenses and be willing to wear these lenses as directed for the duration of the study.
- •On examination, have ocular findings considered to be within normal limits
- •Normal binocularity (no amblyopia or strabismus, and no anisometropia of greater than 2.00D)
- •Be willing and able to follow instructions and attend the schedule of follow-up visits.
排除标准
- •Does not meet the any of the above inclusion criteria
- •Not able or willing to provide informed consent and assent
- •Requires concurrent ocular medication
- •Eye injury or surgery within twelve weeks immediately prior to enrollment
- •Pre-existing ocular condition that would preclude contact lens fitting
- •Currently enrolled in an ophthalmic clinical trial
- •Pregnant or lactating or expect to become pregnant during the trial
- •Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
- •Allergy or sensitivity to any product used in this trial
- •Any systemic disease including autoimmune disease, immunocompromising diseases, connective tissue disease, clinically significant atopic diseases, insulin dependent diabetes, use of medications including corticosteroids and antimetabolites that may affect the eye or be exaggerated by contact lenses.
- •Strabismus/amblyopia
- •Habitually uncorrected anisometropia ≥2.00
- •Subjects who have undergone corneal refractive surgery
- •Subjects with severe corneal irregularity contraindicating lens wear
- •Inability to wear contact lenses, or an unacceptable contact lens fit
- •Poor or unacceptable fit with any study lens
结局指标
主要结局
First fit success rate
时间窗: 1 month
Percentage of children successfully fit in the first lens pair ordered (as determined by the PI)
次要结局
未报告次要终点