Visual and Refractive Outcomes of a New Diffractive Trifocal Toric Intraocular Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Visual performance
研究概览
简要总结
The purpose of this study is to investigate the visual performance and refractive predictability with the diffractive toric Finevision POD FT IOL. Predicted and achieved visual outcomes, visual performance at near, intermediate and far distance as well as photic phenomena, rotational stability and spectacle independence will be investigated. The follow-up period is 3 months after which vision and refraction should have stabilized.
详细描述
This prospective study was performed to investigate the visual performance and refractive predictability with the diffractive toric Finevision POD FT IOL (PhyslOL, Belgium). Predicted and achieved visual outcomes, visual performance at near, intermediate and far distance as well as rotational stability have been analyzed. The follow-up period was 6 months. All IOL implantations were performed by the investigators Dr. Filomena Ribeiro and Dr. Tiago B Ferreira (Hospital da Luz, Lisboa, Portugal). The study population consists of patients undergoing routine cataract surgery. The study patients underwent binocular implantation of Finevision IOLs depending on the preoperative amount of corneal astigmatism (either a toric POD FT IOL in both eyes or a POD FT in the study eye and a non-toric POD F IOL in the contralateral eye).
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 21 and older
- •bilateral implantation of a Finevision trifocal diffractive IOL (either a POD FT in both eyes or a POD FT in the study eye and a POD F in the contralateral eye)
- •bilateral cataract surgery with grade 1-4 cataract
- •regular corneal astigmatism of 1.00 D or more before surgery in the study eye
- •previous written informed consent to surgery. Written informed consent to participation in the study and data protection
排除标准
- •relevant concomitant ophthalmic diseases (such as pseudoexfoliation, glaucoma, traumatic cataract and other co-morbidity that could affect capsular bag stability (e.g. Marfan syndrome)
- •irregular corneal astigmatism, any abnormality in corneal topography
- •systemic disease with impact on visual outcome
- •disability to understand and/or fill in patient questionnaires
- •history of other relevant previous ocular surgery (such as corneal surgery, glaucoma surgery, vitreoretinal surgery) which might affect capsular stability or visual outcomes
- •expected residual cylinder ≥ 0.50 D
结局指标
主要结局
Visual performance
时间窗: 3 Months
The purpose of this study is to investigate the visual performance of the diffractive toric Finevision POD FT IOL.
Refractive predictability
时间窗: 3 Months
The purpose of this study is to investigate the refractive predictability of the diffractive toric Finevision POD FT IOL.
次要结局
- Visual performance at near, intermediate and far distance(3 Months)
- Refractive predictability: rotational stability(3 Months)
- Refractive predictability: spectacle independence(3 Months)
- Visual performance : predicted and achieved(3 Months)
- Refractive predictability: photic phenomena(3 Months)