NCT05389072招募中不适用
Evaluation of The Comfort of Orthokeratology Lenses Fit Using A New Software
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 57
- 试验地点
- 7
- 主要终点
- Comfort
研究概览
简要总结
As new orthokeratology fitting software emerges onto the market, it is of interest to assess their usefulness in guiding eye practitioners with lens fit. The goal of this study is to evaluate the comfort of Paragon orthokeratology lenses when they are fit using the new Procornea software.
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
- 6 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are 6- 35 years of age
- •Have had a self-reported visual exam in the last two years
- •Have a contact lens refraction that fits within the available parameters of the study lenses
- •Are able to read (or be read to), understand and sign the assent document if under 18 years old or are able to read, understand and sign the consent document if aged 18 or older (Children 6-years of age will not be asked to sign the assent form as per STERLING IRB.);
- •Are under 18 years old and are accompanied by a parent or legal guardian who is able to read, understand and sign the parental information and permission document;
- •Are willing to comply with the wear schedule (8 hour per night for every night, while sleeping)
- •Are willing to comply with the visit schedule
- •Have a refractive spherical component of their prescription between -0.50 and up to -6.00 diopters (inclusive) AND a refractive cylinder of no more than -1.75 diopters
- •Have a refractive spherical component ≥ cylinder component
- •Have a minimum visual acuity of +0.20 logMAR with each eye, when refracted at the Screening visit
- •Have clear corneas and no active ocular disease
- •Have no medication, medical condition, or ocular conditions that contraindicate contact wear OR are expected to affect lens comfort or vision across the 1-month study duration, in the opinion of the investigator
- •Can be shown to have stable keratometry for at least the previous 1 month, if they have previously worn orthokeratology lenses.
排除标准
- •Present at screening visit with the presence of ocular or systemic disease or reports the use medications which might interfere with orthokeratology contact lens wear, such as keratoconus, diabetes mellitus, steroid eye drops
- •Have a post-treatment predicted flat K value ≤38.00D (e.g. Patient baseline flat keratometry value = 40.00, patient has 2.00D of myopic refractive error. 40.00-2.00= 38.00D)
- •Have a known sensitivity to the diagnostic sodium fluorescein to be used in the study
- •Are pregnant, planning a pregnancy or lactating
- •Have amblyopia
- •Have presbyopia or has dependence on spectacles for near work over the contact lenses
- •Present at screening visit with the presence of clinically significant (grade >3; Efron scale) anterior segment abnormalities.
- •Present at screening visit with slit lamp findings that would contraindicate orthokeratology contact lens wear such as:
- •Pathological dry eye or associated findings
- •Pterygium, pinguecula, or corneal scars within the visual axis
- •Neovascularization > 0.75 mm from of the limbus
- •Giant papillary conjunctivitis (GPC) worse than grade 1
- •Anterior uveitis or iritis (past or present)
- •Seborrheic eczema, Seborrheic conjunctivitis
- •History of corneal ulcers or fungal infections
- •Poor personal hygiene
结局指标
主要结局
Comfort
时间窗: 1 month
Comfort of lenses (VAS 0-10, 0,5 steps) after insertion, subjects will be graded on a scale from 0 to 10 with 0=painful, 10= can't feel the lenses
次要结局
未报告次要终点
研究者
研究点 (7)
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