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临床试验/NCT06220331
NCT06220331已完成不适用

Intensity Lenses Post Operation Standard of Care Visits - Data Collection.

Hanita Lenses1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2023年7月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
31
试验地点
1
主要终点
The aim of this study is to evaluate performance of Hanita Lenses Intensity SL IOL.

研究概览

简要总结

Hanita Lenses new Intensity IOL and Intensity Toric were been designed to have very high efficiency of light leading to a high MTF, wide focal ranges of far, intermediate and near vision and minimal loss of light energy. The main purpose of this study is to collect existing post-operative data based on standard of care follow up visits at the clinic.

详细描述

Different multifocal intraocular lens (MIOL) designs have been used for more than 25 years1. Unlike conventional mono focal intraocular lenses (IOLs), which bend light to a single focus point on the retina, MIOLs are designed to help patients to see at varying distances using different points of focus2. MIOLs used in clinical practice were either refractive initially, or later diffractive in their optical design. Refractive MIOLs incorporate a lens optic with different optical powers in different parts of the lens, while diffractive MIOLs use diffractive steps on the lens to distribute light rays into two or more principal foci. Irrespective of the design type, however, all MIOLs involve some form of optical compromise and a process of neuroadaptation for the patient.

Intensity SL intraocular lenses (IOLs) represent the latest in premium lens technology. Intensity SL lenses provide clear vision at all distances - from near to far - thus offering the best chance of true spectacle independence.

Despite the promising results obtained with the latest generation of MIOLs, many surgeons remain reluctant to implant these lenses. Visual symptoms such as glare and haloes, reduced contrast sensitivity and night vision problems are all known complications of multifocal implants and have served to hamper wider acceptance of these IOLs4.

Hanita Lenses new Intensity IOL and Intensity Toric were been designed to have very high efficiency of light leading to a high MTF, wide focal ranges of far, intermediate and near vision and minimal loss of light energy. The main purpose of this study is to collect existing post-operative data based on standard of care follow up visits at the clinic.

研究设计

研究类型
Observational
观察模型
Other
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

入选标准

  • Patient over the age of 18
  • Patient who underwent bilateral implantations with Hanita Lenses Intensity IOL

排除标准

  • Patients who don't have any follow up visits after implantation

结局指标

主要结局

The aim of this study is to evaluate performance of Hanita Lenses Intensity SL IOL.

时间窗: 1-3 months

Performance of the IOL will be evaluated by assessing the defocus Curve and visual acuity for far, intermediate and near distance after Intensity SL IOL implantation.

次要结局

  • The second aim of this study is to evaluate the visual phenomena post-operation.(1-3 months)

研究者

发起方
Hanita Lenses
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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