Clinical Results of a Monofocal Aspheric Bitoric Intraocular Lens With Plate Haptics in Hyperopic Eyes (HIPER-AT-TORBI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Measurement of the refractive error
研究概览
简要总结
Observational post-marketing study with prospective follow-up of CE marked medical devices aimed at the treatment of hyperopia and astigmatism in patients with cataract. The objective is to evaluate the clinical results of the implantation of the monofocal aspheric bitoric intraocular lens (IOL) with AT-TORBI 709 plate haptics in cataract surgery of hyperopic eyes with astigmatism.
详细描述
All patients participating in the study will have the intraocular lens (IOL) AT TORBI 709 implanted from Carl Zeiss Meditec AG, Jena, Germany, with CE marking. All patients will be treated according to standard clinical practice. A preoperative and postoperative evaluation will be carried out one month, six and twelve months after the intervention where the following tests will be performed: refraction, corneal topography, measurement of visual acuity with and without correction, slit lamp examination, eye biometry using the IOLMaster 700 Carl Zeiss Meditec AG, Jena, Germany, CE marked optical non-contact biometer, contrast sensitivity with the CC-100 screen (Topcon Europe, The Netherlands), and the Catquest-9SF (European Registry of Quality Outcomes for Cataract and Refractive Surgery, founded by the European Society of Cataract and Refractive Surgeons). The sponsor has received an unrestricted research grant by Zeiss.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of 50 years of age or older to undergo cataract surgery with phacoemulsification
- •Patient who signs the informed consent.
- •Regular corneal astigmatism between 1.0D and 4.0D.
- •IOL power between 21D and 26D
- •Target-target distance measured with the IOLMaster 700 biometer (Carl Zeiss Meditec AG) greater than 11.6 mm.
- •Patients with hyperopia between 1.0D and 4.0D.
排除标准
- •Patients who do not provide informed consent
- •Patients who do not understand the study procedure
- •Previous corneal surgery.
- •Irregular cornea (eg keratoconus)
- •myopic patients
- •Eye abnormalities or pathologies that could reduce the visual function or stability of the IOL (eg severe amblyopia or macular degeneration)
结局指标
主要结局
Measurement of the refractive error
时间窗: 12 months
Measurement of the refractive error (equivalent spherical error, the refractive cylinder and the astigmatism vectors (J0 and J45) )
Measurement of the rotational stability
时间窗: 12 months
Measurement of the rotational stability
次要结局
- Measure of visual acuity(12 months)
- Measure of corneal topography(12 months)
- Measure of ocular biometry(12 months)
- Measure of contrast sensitivity(12 months)
- Satisfaction questionaire(12 months)
- Slit lamp examination(12 months)