NCT01827748已完成不适用
Evaluation of a Surgical Microscope Mounted Autorefractor When Used on Patients Lying in a Supine Position
Adventus Technology2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Assessment of the accuracy and repeatability of the Test device compared to the Control
研究概览
简要总结
The purpose of this study is to evaluate the accuracy and repeatability of an individually validated prototype autorefractor designed to be mounted on a surgical microscope.
详细描述
The purpose of this study is to evaluate the accuracy and repeatability of an individually validated prototype autorefractor designed to be mounted on a surgical microscope. The goal is to evaluate 20 subjects with both the investigational instrument followed by a commercially available instrument.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Be at least 18 years of age as of the date of evaluation for the study.
- •Read the Informed Consent
- •been given an explanation of the Informed Consent
- •indicated understanding of the Informed Consent
- •signed the Informed Consent document.
- •Be willing and able to adhere to the instructions set forth in this protocol and able to participate in all scheduled evaluations.
- •Be in good general health, based on his/her knowledge.
- •Have a refractive error within the range of -10.00 to +30.00 Diopter sphere and up to 5.00 Diopter of refractive cylinder .
- •Have manifest refraction (BCVA) Snellen visual acuities (VA) equal to or better than 20/25 in each eye. -
排除标准
- •Subjects may not be enrolled in this study if any of the following apply: The subject is/has:
- •Allergy to Tropicamide or a previous adverse reaction to Tropicamide.
- •Poor personal hygiene as observed by the investigational site personnel.
- •Currently pregnant (to the best of the subject's knowledge) or is lactating.
- •Previous refractive surgery or current or previous orthokeratology treatment.
- •Aphakic or pseudophakic or has cataracts that interfere with visual acuity.
- •Ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermia, keratoconus or type II diabetes.
- •The need for topical ocular medications or any medication which might interfere with the study evaluations.
- •The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
- •Slit lamp findings, including but not limited to:
- •Pathological dry eye or associated dry eye symptoms with decreased tear levels and punctuate staining > Grade 2 Pterygium Corneal scars within the visual axis Neovascularization or ghost vessels > 1.0 mm in from the limbus Giant papillary conjunctivitis (GPC) of > Grade 2 Anterior uveitis or iritis Seborrheic eczema, seborrheic conjunctivitis or blepharitis
结局指标
主要结局
Assessment of the accuracy and repeatability of the Test device compared to the Control
时间窗: 1 Hour
Comparative auto refractor device measurement variation is defined as +/-0.25 Diopters
次要结局
未报告次要终点
研究者
研究点 (2)
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