NCT03060954终止不适用
A Multicentre, Controlled, Randomised, Single-blind, Two-armed Trial Evaluating the Visual Performance, Quality of Vision and Subjective Outcomes After Bilateral Implantation of MINI WELL Ready® or FineVision® in Patients With Cataract Surgery.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- SIFI SpA
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Defocus curve - binocular
研究概览
简要总结
Interventional, Multicentre, controlled, randomized, single blind, twoarmed non-inferiority trial
详细描述
To evaluate the non-inferiority of the progressive extended depth of focus Intraocular Lens MINI WELL READY® in terms of visual performance, quality of vision and subjective outcomes versus the trifocal Intraocular Lens FineVision® after a follow up period of 2-6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Bilateral cataract surgery required, no other ocular comorbidities
- •Healthy corneas, not treated surgically
- •Available for second-eye surgery within 1 week of the initial operation
- •Spherical refraction between -8.00D and +6.00D
- •Willing to adhere to the study visit schedule
- •Normal anterior and posterior segments
- •Clear intraocular media - other than cataract
- •To benefit from a social security system before being enrolled
- •Written informed consent consistent with local regulation research in human subjects
排除标准
- •Any previous history of ocular trauma or prior ocular surgery (including previous cataract surgery and CLRIs)
- •Ocular comorbidities determining potential postoperative Visual Acuity less than 0.50 decimal (0.3 logMAR)
- •Expected to require retinal laser treatment
- •A history of retinal detachment or predisposition for such disorder
- •Psudoexfoliation
- •Abnormal pupil size and position
- •Pupil size > 7 mm under mesopic condition
- •Use of contact lenses 30 days before the preoperative visit
- •Corneal warpage (e.g. Keratoconus, Pellucid Marginal Corneal Degeneration or Keratoglobus)
- •Corneal astigmatism greater than 0.75D
- •Zonular laxicity
- •Absence of adequate capsular support for the implant of the intraocular lens in the capsular bag
- •Microphthalmus
- •Active ocular disease in the operative eye, for example, chronic uveitis, proliferative diabetic retinopathy, chronic glaucoma unresponsive to medication, corneal decompensation and corneal endothelial cell insufficiency (such as Fuch's endothelial dystrophy)
- •Suspected microbial infection
- •Irregularities and capsulorexis decentralization
- •Surgical difficulties that may increase the risk of complications such as persistent bleeding, significant iris damage, an uncontrollable intraocular hypertonia, or damage due to significant vitreous loss
- •Patients in whom the intraocular lens may interfere with the ability to observe, diagnose or treat diseases of the posterior segment
- •Patients in whom neither the posterior capsule nor the zonula can provide adequate support to the lens
- •Subjects with any systemic disease that could increase operative risk or confound the outcome
- •Pregnant or lactating or planning a pregnancy at the time of enrolment
- •Vulnerable subjects (children <18 years, people in guardianship or trusteeship or inability to give an informed consent)
- •Subjects participating in a concurrent clinical trial or if they have participated in an ophthalmology clinical trial within the last 30 days
研究组 & 干预措施
MINI WELL READY ®
Experimental
BILATERAL IMPLANTATION OF MINI WELL READY®, A PROGRESSIVE EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS IN PATIENTS WITH CATARACT SURGERY
干预措施: MINI WELL READY ® (Device)
FineVision ®
Other
FINE VISION®, A TRIFOCAL INTRAOCULAR LENS IMPLANTATION IN PATIENTS WITH CATARACT SURGERY
干预措施: FINE VISION® (Device)
结局指标
主要结局
Defocus curve - binocular
时间窗: 6 months
Defocus curve assessment
次要结局
未报告次要终点
研究者
研究点 (2)
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