Clinical Evaluation of Reproducibility of Keratometric Measurements and Influencing Factors in Cataract Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The primary objective is to determine whether application of highly viscid eye drops in normal eyes leads to a change in keratometry measurements after 30 seconds.
研究概览
简要总结
The investigational device is an approved biometry device to perform biometric measurements preoperatively to calculate the needed IOL power.
First, two native measurements at the IOL Master will be performed. Thereafter randomly assigned artificial tears are instilled in the eye and biometry will be repeated within 30 seconds, as well as after 2 and 5 minutes.
At least 24hours after those measurements, two native measurements at the IOL Master will be performed. Thereafter, the not yet used artificial tears are instilled in the eye and biometry will be repeated within 30 seconds, as well as after 2 and 5 minutes.
Examinations will be implemented in accordance with the approved investigational plan on subjects and includes: repeated biometry without and with artificial tear drops.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Which eye as well as the order of artificial eye drops will be randomized. Randomization information will be put in a sealed envelope on screening date and opened in operating theatre right before procedure start.
入排标准
- 年龄范围
- 40 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed uni- or bilateral age-related cataract
- •Age 40 to 95
- •Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
排除标准
- •Corneal abnormality (Corneal scaring)
- •usage of artificial tears/eyedrops 24h before the examination
- •necessity of any topical therapy of the eye (i.e. glaucoma)
- •active ocular or nasal allergies or corneal or conjunctival infection
- •abnormality of the nasolacrimal drainage apparatus
- •dry eye severity level 4 (severe and/or disabling constant discomfort and visual symptoms, marked conjunctival injection, filamentary keratitis, mucus clumping, tear debris, ulceration, trichiasis, keratinization, symblepharon)
- •lid deformities
- •Preceding ocular surgery or trauma
- •Pregnancy
- •Lactation
- •Uncontrolled systemic or ocular disease
结局指标
主要结局
The primary objective is to determine whether application of highly viscid eye drops in normal eyes leads to a change in keratometry measurements after 30 seconds.
时间窗: 30 seconds
The change in measured k-values (k, k1, k2 in mm) before and after instillation of artificial eye drops will be calculated
次要结局
- To determine whether application of slightly viscid eye drops in normal and in dry eyes leads to a change in keratometry measurements after 30 seconds, 2 minutes or 5 minutes. These objectives will be assessed analogously to the primary objective(30 seconds, 2 minutes or 5 minutes)
- To determine whether application of highly viscid eye drops in normal eyes leads to a change keratometry measurements after 2 minutes or 5 minutes. These objectives will be assessed analogously to the primary objective.(2, 5minutes)
- To determine whether application of highly viscid eye drops in dry eyes leads to a change in keratometry measurements after 30 seconds, 2 minutes or 5 minutes. These objectives will be assessed analogously to the primary objective(30 seconds, 2 minutes or 5 minutes)
研究者
Rupert Menapace
Principal Investigator
Medical University of Vienna