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临床试验/CTRI/2018/02/011832
CTRI/2018/02/011832招募中不适用

Comparison of post cataract surgery visual outcomes in patients bilaterally implanted with Eyecryl ACTV Diffractive Multifocal IOL & AcrySof® IQ ReSTOR® Multifocal IOL

Biotech Vision Care Pvt Ltd1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2017年7月24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
68
试验地点
1
主要终点
Contrast sensitivity(Low and High)

研究概览

简要总结

This prospective study aims at assessing and comparingthe visual outcomes in patients undergoing restore (AcrySof® IQ ReSTOR®) and biotech (Eyecryl ACTV Diffractive) multifocal IOL implantation afteruneventful cataract surgery. Patients undergoing bilateral cataract surgeryfrom the period of May 2017 to April2018 will be included in the study. Aperiod up of   six monthswill be consideredfor analysis of data. Certain parameters will be evaluated to determine theoutcome such as visual acuity, contrast sensitivity, higher order aberrations,patient’s visual satisfaction (with the help of VFQ-33 questionnaire) postcataract surgery.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Patients who has been implanted bilaterally with any one of the Multifocal IOL: Eyecryl ACTV Diffractive Multifocal IOL OR AcrySof® IQ ReSTOR® multifocal IOL will be included in the study.
  • Age 18 and older Regular corneal topography and corneal astigmatism Preoperative & postoperative corneal astigmatism of ≤ 0.75D Clear intraocular media Availability, willingness and sufficient cognitive awareness to comply with examination procedures Written informed consent for participation in the study and data protection.

排除标准

  • Patients with best corrected vision less than 6/9 and or N/6 Pupil Size: > 5 mm scotopic size Previous ocular surgery.
  • Any active ocular disease (Diabetic retinopathy, macular degeneration, glaucoma with field defects and irregular corneal astigmatism) Any ocular pathology (corneal, retinal) Subject who are professional Pilots/truck/Car Drivers.

结局指标

主要结局

Contrast sensitivity(Low and High)

时间窗: Pre Operative | 1 month | 3 months | 6 months

To Compare Visual acuity (Distance, Near and Intermediate vision),

时间窗: Pre Operative | 1 month | 3 months | 6 months

次要结局

  • High Order aberrations(Reading Speed)

研究者

发起方
Biotech Vision Care Pvt Ltd
申办方类型
Pharmaceutical industry-Indian

研究点 (1)

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