跳至主要内容
临床试验/NCT05697978
NCT05697978招募中不适用

Distance and Intermediate Visual Acuity in Patients With Implanted Monofocal Negative Aspheric Intraocular Lens

Faculty Hospital Kralovske Vinohrady6 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
6
主要终点
Monocular corrected Distance Visual Acuity (CDVA)

研究概览

简要总结

To get the visual outcomes for distance and intermediate and binocular defocus curve in patients with implanted monofocal intraocular lens Clareon (IOL; model SY60CL; Alcon Vision LLC) at 3 months after the surgery.

详细描述

The goal of refractive cataract surgery is to remove the opacity, or cataract and to produce the desired refractive outcome. In most cases, the desired outcome is an emmetropic eye, or an eye that sees 20/20 Snellen for distance vision post-surgery with the implant of a monofocal IOL. This, however, does not offer much in the way of intermediate and near vision. The increased desire for simultaneous distance, intermediate and near vision has increased the popularity of multifocal IOLs (MIOLs). However MIOLs provide visual acuity for all distances, they has occurence of optical phenomena such as glare and halo and lower contrast sensitivity. Extended depth of focus (EDOF) lens should provide distance vision as good as monofocal lens and intermediate vision better than monofocal but without or with less appearance of optical phenomenon or decreased contrast sensitivity.

This study is prospective, multi-center, conducted from 10/2022 to 08/2023 in the Ophthalmology department of Faculty Hospital Kralovske Vinohrady in Prague, in Eye Center Prague and Eye Clinic SOMICH (Karlovy Vary). The research protocol was explained to all participants and informed consent was signed before enrolling patient to the study. The study was approved by the Ethics Committee of Faculty Hospital Kralovske Vinohrady and will enrolled up to 100 patients with presence of cataract in both eyes.

Bilateral clear corneal phacoemulsification and IOL implantation is performed by two experienced surgeon using the same technique in both eyes. The surgical process involved topical anesthesia, superior 3-step clear corneal incision (2,2mm), 5,0mm curvilinear capsulorhexis, phacoemulsification, bilateral irrigation- aspiration and implantation of monofocal aspheric intraocular lens (Clareon Alcon vision LLC).

Patients are scheduled for visit at 3 months after the surgery.

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

盲法说明

no masking

入排标准

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

入选标准

  • presence of cataract in both eyes
  • no other ocular pathology affecting visual acuity
  • bilateral phacoemulsification cataract surgery was arranged for both eyes
  • corneal astigmatism up to 0,5 cylinder (measured by IOL Master biometry)
  • dioptric power of both selective lens within 1,5 D range in one patient
  • selecting IOL power between 15 D and 28 D power range

排除标准

  • complicated cataract
  • corneal opacities or irregularities
  • amblyopia
  • anisometropia
  • coexisting ocular pathologies
  • history of ocular surgery
  • refusal or unable to maintain follow-up

结局指标

主要结局

Monocular corrected Distance Visual Acuity (CDVA)

时间窗: 3 months

Monocular corrected distance visual acuity (CDVA) is measured at 4 m using an ETDRS (Early Treatment Diabetic Retinopathy Study) illumination cabinet (Precision Vision) under photopic conditions.

Binocular corrected Distance Visual Acuity (CDVA)

时间窗: 3 months

Binocular corrected distance visual acuity (CDVA) is measured at 4 m using an ETDRS (Early Treatment Diabetic Retinopathy Study) illumination cabinet (Precision Vision) under photopic conditions.

Monocular distance corrected intermediate visual acuity (DCIVA)

时间窗: 3 months

Monocular distance corrected intermediate visual acuity is measured using printed ETDRS charts for distance of 66cm

Binocular uncorrected intermediate visual acuity (UIVA)

时间窗: 3 months

Binocular intermediate visual acuity is measured using printed ETDRS charts for distance of 66cm

Binocular distance corrected intermediate visual acuity (DCIVA)

时间窗: 3 months

Binocular distance corrected intermediate visual acuity is measured using printed ETDRS charts for distance of 66cm

Monocular uncorrected intermediate visual acuity (UIVA)

时间窗: 3 months

Monocular intermediate visual acuity is measured using printed ETDRS charts for distance of 66cm

次要结局

  • Binocular defocus curve(3 months)

研究者

发起方
Faculty Hospital Kralovske Vinohrady
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Andrea Janekova

Principal Investigator

Faculty Hospital Kralovske Vinohrady

研究点 (6)

Loading locations...

相似试验