A Comparative Study of Visual Outcome of Two Extended Depth of Focus Intraocular Lenses After Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Range of vision of the different IOLs represented by the defocus curve
研究概览
简要总结
The investigators aim to compare the visual performance of the most recently introduced extended depth of focus intraocular lenses ; AcrySofTM IQ VivityTM and TECNIS SynergyTM ( an extended depth of focus IOL ) regarding the range of vision (using defocus curve ) , contrast sensitivity( through the modulation transfer function curves ) and their effect on ocular aberrations as the ivestigators believe that proper study of these aspects could influence the investigators choice and guidance to the cataract patient about the most suitable presbyopia correcting IOL .
详细描述
Presbyopia-correcting IOLs can be divided into 4 broad categories: Enhanced monofocal IOLs , Mutifocal IOLs (including diffractive or refractive designs) , extended depth-of-focus (EDOF) IOLs, and accommodative IOLs .
Standard multifocal lenses ( e.g : FineVision® (Physiol, Liège, Belgium) are diffractive IOLs which split incident light into two or more points of focus, but these lenses are limited by the optical aberrations and the presence of secondary out-of-focus image and photic phenomena .
The new Tecnis® EyhanceIOL (model ICB00, Johnson & Johnson Vision, Santa Ana, CA, USA) is a refractive modified monofocal lens with better intermediate visual acuity than standard monofocal IOLs and eliminates the dysphotopsia that is common with the standard multifocal IOLs and compensates for the spherical aberration of the cornea due to its high order aspheric profile .
The EDOF IOL, or extended range of vision IOL, incorporates a new technology which createsa single-elongated focal point to enhance the depth-of-focus, contrary to monofocal IOLs (in which light is focused on one single point) or MF IOLs (having 2 or 3 discrete points). This elongated focus is introduced to eliminate the overlapping of near and far images caused by traditional MF IOLs, thus eliminating the halo effect .However , EDOF IOLs are thought to be inferior to standard trifocal IOls regarding near vision.
AcrySof™ IQ Vivity™ Extended Vision Intraocular Lens (Alcon, Fort Worth, Texas,USA ) was approved by the Food and Drug Administration in February 2020 and it is considered the most recently introduced non-diffractive EDOF IOL . TECNIS Synergy™ Intraocular Lens (Model ZFR00V) (Johnson & Johnson Vision,SantaAna, CA, USA) is a continuous depth of focus intraocular lens and was approved by food and drug administration in April 2021 . it combines both elements of standard multifocal and extended depth of focus with preservation of high contrast sensitivity .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing cataract surgery.
- •Preoperative corneal astigmatism equal to or less than 0.75 D
排除标准
- •Other ocular comorbidities which may affect the outcome of our research such as glaucoma, corneal opacities , chronic or recurrent anterior uveitis, diabetic retinopathy , age -related macular degeneration.
- •Previous ocular surgeries
结局指标
主要结局
Range of vision of the different IOLs represented by the defocus curve
时间窗: within 1 month after surgery
monocular defocus curve will be obtained by using the best corrected distance refraction and measuring the visual acuity Between +1.50 D and- 2.50 D in 0.5-D defocus steps, except in the region from +0.50 D through\* 0.50 D, which would be done in -0.25D steps. Letters will be randomly presented to avoid memorization.
次要结局
- Contrast sensitivity (which will be objectively assessed through modulation transfer function ) - Photic phenomena (which will be objectively expressed through the ocular aberration ).(within 1 month after the surgery)
研究者
Alaa Mohamed Badawy
Assistant lecturer
Cairo University