Capella Scientia (SCDX) Development Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 5
- 主要终点
- Manifest Refraction Spherical Equivalent (MRSE)
研究概览
简要总结
This study involves collecting biometry and aberration data using the next generation biometer, Unity DX.
详细描述
In this prospective, noninterventional, single-arm, unmasked, multicenter study, 4 different subject cohorts will be enrolled simultaneously to collect biometry and aberrometry data using Unity DX. This study will be conducted in India, Spain, and the Philippines.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and sign an IRB/IEC approved consent form;
- •Willing and able to attend study visit(s) as required by the protocol;
- •Consenting age at the jurisdiction of study site;
- •Other group-specific, protocol required inclusion criteria may apply.
排除标准
- •Women of child-bearing potential;
- •Unable to fixate due to nystagmus or other eye movement abnormality (e.g., significant strabismus);
- •Unclear optical media preventing data capture from all devices in the study;
- •Contraindicated for pupil dilation (e.g., narrow angles, allergies) per investigator's clinical judgment;
- •Any ocular disease and/or condition that, in the investigator's clinical judgment, may put the subject at significant risk, may compromise study results, or may interfere significantly with the subject's participation in the study;
- •Other group-specific, protocol required exclusion criteria may apply.
研究组 & 干预措施
Group 1
Subjects/eyes previously implanted with an Alcon monofocal or multifocal presbyopia correcting IOL. Measurements will be taken with Unity DX and SMARTCataract DX (SCDX) Biometer and either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer depending on which device is used at site.
干预措施: Unity DX and SMARTCataract DX (SCDX) Biometer (Device)
Group 1
Subjects/eyes previously implanted with an Alcon monofocal or multifocal presbyopia correcting IOL. Measurements will be taken with Unity DX and SMARTCataract DX (SCDX) Biometer and either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer depending on which device is used at site.
干预措施: IOLMaster 700 Biometer (Device)
Group 1
Subjects/eyes previously implanted with an Alcon monofocal or multifocal presbyopia correcting IOL. Measurements will be taken with Unity DX and SMARTCataract DX (SCDX) Biometer and either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer depending on which device is used at site.
干预措施: Argos with Alcon Image Guidance Biometer (Device)
Group 2
Subjects/eyes with planned implantation of an Alcon monofocal or monofocal toric IOL. Measurements will be taken with Unity DX and SMARTCataract DX (SCDX) Biometer and either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer depending on which device is used at site.
干预措施: Unity DX and SMARTCataract DX (SCDX) Biometer (Device)
Group 2
Subjects/eyes with planned implantation of an Alcon monofocal or monofocal toric IOL. Measurements will be taken with Unity DX and SMARTCataract DX (SCDX) Biometer and either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer depending on which device is used at site.
干预措施: IOLMaster 700 Biometer (Device)
Group 2
Subjects/eyes with planned implantation of an Alcon monofocal or monofocal toric IOL. Measurements will be taken with Unity DX and SMARTCataract DX (SCDX) Biometer and either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer depending on which device is used at site.
干预措施: Argos with Alcon Image Guidance Biometer (Device)
Group 3
Subjects/eyes with with prior refractive surgery such as LASIK or PRK and planned implantation of an Alcon monofocal or monofocal toric IOL. Measurements will be taken with Unity DX and SMARTCataract DX (SCDX) Biometer and either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer depending on which device is used at site.
干预措施: Unity DX and SMARTCataract DX (SCDX) Biometer (Device)
Group 3
Subjects/eyes with with prior refractive surgery such as LASIK or PRK and planned implantation of an Alcon monofocal or monofocal toric IOL. Measurements will be taken with Unity DX and SMARTCataract DX (SCDX) Biometer and either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer depending on which device is used at site.
干预措施: IOLMaster 700 Biometer (Device)
Group 3
Subjects/eyes with with prior refractive surgery such as LASIK or PRK and planned implantation of an Alcon monofocal or monofocal toric IOL. Measurements will be taken with Unity DX and SMARTCataract DX (SCDX) Biometer and either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer depending on which device is used at site.
干预措施: Argos with Alcon Image Guidance Biometer (Device)
Group 4
Subjects/eyes with keratoconus, a progressive cornea disorder. Measurements will be taken with Unity DX and SMARTCataract DX (SCDX) Biometer and either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer depending on which device is used at site.
干预措施: Unity DX and SMARTCataract DX (SCDX) Biometer (Device)
Group 4
Subjects/eyes with keratoconus, a progressive cornea disorder. Measurements will be taken with Unity DX and SMARTCataract DX (SCDX) Biometer and either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer depending on which device is used at site.
干预措施: IOLMaster 700 Biometer (Device)
Group 4
Subjects/eyes with keratoconus, a progressive cornea disorder. Measurements will be taken with Unity DX and SMARTCataract DX (SCDX) Biometer and either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer depending on which device is used at site.
干预措施: Argos with Alcon Image Guidance Biometer (Device)
结局指标
主要结局
Manifest Refraction Spherical Equivalent (MRSE)
时间窗: Group 1 and Group 4: Day 0; Group 2 and Group 3: Screening (Day -30 to Day -1), Day 30 to 60 postoperative, Day 70 to 100 postoperative
A manifest refraction (manual refraction) will be performed using a phoropter. The spherical equivalent is calculated by adding the sum of the sphere power with half of the cylinder power. MRSE will be reported in diopters.
次要结局
未报告次要终点