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临床试验/NCT06891092
NCT06891092尚未招募不适用

Comparison of Quality of Vision After Implantation of Monofocal Depth-enhanced Intraocular Lenses in Patients Undergoing Bilateral Cataract Surgery

Medical University of Bialystok2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
2
主要终点
Visual acuity at intermediate distance

研究概览

简要总结

Comparison of the outcomes of bilateral implantation of extended depth of vision (EDOF) intraocular lenses (IOLs): the Rayone EMV and the Vivinex Impress XY1-EM in patients with cataract

详细描述

Cataracts are one of the leading causes of visual impairment and blindness worldwide. Modern cataract surgery by phacoemulsification with intraocular lens implantation is the gold standard of treatment. Conventional monofocal intraocular lenses are still the most commonly used intraocular lenses today. They allow good uncorrected visual acuity to the far distance, while the patient can achieve good visual acuity to the intermediate near distance with glasses.

However, in developed countries, patients expect good quality vision not only to the far distance, but also to intermediate and near distances due to the many daily activities that require this range of vision (reading on tablets and smartphones, driving, carrying on a conversation). To meet these expectations, most intraocular lens manufacturers have introduced extended depth-of-field lens technology, which provides good visual acuity for distance and intermediate distances with few visual side effects. These lenses achieve satisfactory uncorrected visual acuity not only for distance, but also for near and intermediate distances.

Summarising the above arguments, it therefore seems that implanting patients with lenses that allow good distance vision and satisfactory vision to intermediate and near distances can result in an increased quality of life after cataract surgery.

Characteristics of the lenses tested RayOne EMV RAO200E lens (Rayner Intraocular Lenses Ltd) -This lens was developed in collaboration with Professor Graham Barrett. It is a preloaded monofocal+/non-diffractive EDOF, hydrophilic lens that provides an extended range of vision by exploiting positive spherical aberration. The overall diameter of the lens is 12.5mm and the optical diameter is 6.0mm. The lens has an aspherical front surface, biconvex shape. Its effect is to amplify/compensate for the cornea's natural positive spherical aberration, resulting in an increased range of acuity. As it meets ISO standards for monofocal intraocular lenses, it is less affected by variable pupil width, decentration and tilt. The RayOne EMV can be used for bilateral emmetropia and is also optimised for use in a monovision system. For emmetropia, it allows better intermediate vision than standard monovision lenses, providing approximately 1.25 D of extended visual range Vivinex impress XY1-EM (Hoya Surgical Optics, Singapore) - is a new monofocal lens made of hydrophobic non-gloss acrylate with aspheric optics that provides extended depth of field in the intermediate range. It has a combination of standard aspheric and even aspheric surface with microscopic angles. No first studies on the clinical properties of this enhanced monofocal lens are available in the literature.

From the available literature, it appears that both lenses have similar visual improvement efficacy with a similar safety profile. There is currently no study in the available literature directly comparing the two in a randomised manner.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age-related bilateral cataract
  • age 21 or older
  • visual acuity > 0.05
  • axial length: 22.0 - 26.0 mm
  • normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
  • written informed consent prior to surgery

排除标准

  • active ocular disease (e.g. chronic severe uveitis, proliferative diabetic retinopathy, chronic glaucoma not responsive to medication)
  • relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX), intraoperative floppy iris syndrome (IFIS)
  • corneal decompensation or corneal endothelial cell insufficiency
  • previous ocular surgery or trauma
  • persons who are pregnant or nursing (pregnancy test will be taken in women of reproductive age)
  • corneal astigmatism > 1 dpt.
  • retinopathies

结局指标

主要结局

Visual acuity at intermediate distance

时间窗: 3 months

The visual acuity at the intermediate distance will be measured using ETDRS charts at a distance of 80 centimetres and compared between the two different IOLs

次要结局

  • Visual acuity at far distance(3 months)
  • Visual acuity at near distance(3 months)
  • Change from baseline in the quality of life(3 months)

研究者

发起方
Medical University of Bialystok
申办方类型
Other
责任方
Sponsor

研究点 (2)

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