Retrospective Study Analysing the Results of Toric and Toric Multifocal Intraocular Lens Implantation During Cataract Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To observe the rotational stability of the implant
研究概览
简要总结
The primary objective of the study is to observe the rotational stability of the implant 30 minutes, one day, 6 weeks, 6 months and 12 months after the implant surgery. In addition, the refraction will be measured as it is directly affected in the event of postoperative rotation. The correlation between postoperative rotation and the following parameters will be determined: PEXS, white-to-white, age, axial length, anterior chamber depth. Visual acuities with and without correction and the best refraction to assess the benefit of the implants will also be investigated.
详细描述
This retrospective study will include approximately 90 eyes of patients (adults) receiving conventional cataract surgery having a preoperative corneal astigmatism of 1.0 D or higher. They had been implanted with the Ankoris or T-Flex or FineVision toric implant (about 30/30 and20). So that the groups are comparable, the inclusion and exclusion criteria will be those applicable to a multifocal implant.
Inclusion criteria for research participants.
- Cataract (with or without presbyopia)
- No pre-existing ocular pathology or history of ocular surgery
- No phacodonesis
PEX patients (pseudoexfoliation syndrome) can be included. Exclusion criteria for research participants. To ensure equivalence of the two comparable groups, the patients with potential postoperative visual acuity less than 5/10, particularly due to an insufficient retinal function or poor corneal condition will be excluded.
In particular the patients with the following pathologies will be excluded:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cataract (with or without presbyopia)
- •No pre-existing ocular pathology or history of ocular surgery
- •No phacodonesis
- •PEX patients (pseudoexfoliation syndrome) can be included.
排除标准
- •To ensure equivalence of the two comparable groups, the patients with potential postoperative visual acuity less than 5/10, particularly due to an insufficient retinal function or poor corneal condition will be excluded.
- •In particular the patients with the following pathologies will be excluded:
- •Irregular astigmatism.
- •Cases of uncontrolled glaucoma.
- •Intraocular inflammation.
- •Narrow anterior chambers (2.5 mm).
- •Amblyopia with potential visual acuity less than 5/
- •Any corneal pathology potentially affecting topography (e.g., keratoconus).
- •Patients with a history of corneal surgery (especially refractive surgery).
- •Patients with diagnosed degenerative visual disorders (e.g., macular degeneration, diabetic retinopathy or other retina diseases or surgery) with known negative impact on visual function possibly leading to visual acuity levels below 0.
- •Patients with a history of ocular trauma.
- •Pathological miosis.
- •Patients with zonular laxity.
- •Patients suffering from chronic uveitis.
- •Patients with monophthalmia. Capsule rupture, intraocular haemorrhage, excessive loss of vitreous, vitreous flare, soft capsules during cataract surgery are also exclusion criteria.
结局指标
主要结局
To observe the rotational stability of the implant
时间窗: 6 Months
Observation of rotational stability of the implant
次要结局
- Visual Acuity(6 Months)