NCT07751172尚未招募不适用
Evaluation of Orthokeratology Lenses With a 5MM Optic Zone Diameter
CooperVision International Limited (CVIL)3 个研究点 分布在 2 个国家目标入组 70 人开始时间: 2026年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- Comfort at 5 Minutes and 1 Month After Final Lens Dispense
研究概览
简要总结
To evaluate the clinical performance and user-reported experience of Paragon CRT contact lenses with a 5mm Optic Zone Diameter (OZD)
详细描述
Prospective, multi-site, clinical study evaluating the first-fit success, visual performance, and ocular health outcomes of 5mm OZD orthokeratology lenses fit empirically.
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
- 7 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A person is eligible for inclusion in the study if they:
- •Are 6- 35 years of age
- •If under 18 years old they are accompanied by a parent or legal guardian who is able to read, understand and sign the parental information and permission document
- •Have had a self-reported visual exam in the last two years
- •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
- •Are willing to comply with the wear schedule (approximately 8 hours 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 lens 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 report 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; ISO scale) anterior segment abnormalities.
- •Present at screening visit with slit lamp findings that would contraindicate orthokeratology contact lens wear such as:
- •1. 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
研究组 & 干预措施
Paragon CRT Orthokeratology contact lens
Other
干预措施: Lens A (paflufocon D) (Device)
结局指标
主要结局
Comfort at 5 Minutes and 1 Month After Final Lens Dispense
时间窗: 5 minutes after insertion
To assess participant-reported comfort of empirically fitted orthokeratology contact lenses by comparing comfort scores measured 5 minutes after lens insertion at the final dispense visit with comfort scores reported after 1 month of lens wear. Comfort will be assessed using a 0 to 10 scale, where 0 indicates "painful" and 10 indicates "cannot feel the lenses
次要结局
未报告次要终点
研究者
研究点 (3)
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