NCT02985723已完成不适用
Prospective Study to Evaluate the Visual Outcome, Cylinder Correction and Patient Satisfaction After Implantation of AT LISA Tri Toric 939MP Intraocular Lenses
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- Best distance-corrected visual acuity for intermediate vision after bilateral implantation
研究概览
简要总结
The aim of the present study is to evaluate the postoperative visual acuity for distance, intermediate and near vision as well as the cylinder correction and the patient satisfaction after bilateral implantation of AT LISA tri toric 939MP IOLs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent
- •Man or woman, over 50 years of age
- •Healthy eyes with bilateral cataract requiring surgical treatment for both eyes
- •Bilateral regular corneal astigmatism (confirmed by topography measurement)
- •Only patients requiring intraocular lenses of a power comprised between sphere +0.0 and +28.0 dioptres and between a cylindrical range of +1.0 to +4.0D in both eyes will be able to participate in the trial.
- •Biometry measurement/cataract density compatible with the IOLMaster evaluation
- •Bilateral uncomplicated cataract surgery and implantation into capsular bag by injector
- •Assured follow-up examinations
排除标准
- •Patients unable to meet the limitations of the protocol or likely of non cooperation during the trial,
- •Patients whose freedom is impaired by administrative or legal order,
- •Monophtalmic patient.
- •Previous ocular surgery, including corneal/refractive surgery,
- •Chronic or recurrent uveitis,
- •Acute ocular disease or external/internal infection,
- •Any kind of macular degeneration and impairment of retina (clinical diagnosis/OCT examination)
- •Diabetes with retinal changes,
- •Pseudoexfoliation syndrome
- •Pathologic myosis
- •Irregular astigmatism, especially keratoconus,
- •Endothelial corneal dystrophy
- •Glaucoma or IOP higher than 21mmHg under ocular hypertension treatment
- •Pseudophakia
- •Cornea guttata; keratoplasty
- •Amotio operation; anamnesis with vitreous surgery
- •Amblyopia
- •Intraocular tumours; endotamponade
- •Phlogistic intraocular processes or other pre-existing processes that permanently limit the best corrected visual acuity to > 0.3 logMAR
- •Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient
- •Pupil diameter over 6 mm in mesopic condition
- •Corneal opacity
研究组 & 干预措施
939MP
Experimental
AT LISA tri toric 939MP intraocular lens
干预措施: AT LISA tri toric 939MP (Device)
结局指标
主要结局
Best distance-corrected visual acuity for intermediate vision after bilateral implantation
时间窗: 12 months after surgery
次要结局
未报告次要终点
研究者
相似试验
已完成
4 期
A Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting Intraocular Lenses (IOLs)CataractNCT01166971Alcon Research65
已完成
4 期
Presbyopia-Correcting Intraocular Lenses (IOLs)CataractNCT00963560Alcon Research132
尚未招募
不适用
Evaluation of the Eyhance and Zoe LensesCataractNCT06665659University Hospital Plymouth NHS Trust50
Unknown
不适用
Prospective Evaluation of Near and Intermediate Visual Outcomes With Monofocal Intraocular Lenses: The Mast StudyPatients Implanted With Monofocal Intraocular LensNCT01191515Innovative Medical200
已完成
不适用
Visual Outcomes After Extended Depth of Focus Intraocular Lens Implantation With and Without Digital AssistancePseudophakiaRefractive ErrorsCataractPresbyopiaNCT06460389Democritus University of Thrace40