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临床试验/CTRI/2024/08/071812
CTRI/2024/08/071812招募中4 期

A Prospective Comparative randomized post marketing clinical study to assess and compare the visual performance and safety of two different trifocal Intraocular lens following bilateral implantation

Biotech vision care pvt ltd1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2024年9月5日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
216
试验地点
1
主要终点
Uncorrected Intermediate Visual Acuity (UIVA) (Photopic)

研究概览

简要总结

Presbyopia is one of the most common causes of vision impairment, affecting an estimated 2 billion people, globally.1 Presbyopia has been associated with negative impacts on quality of life in people aged 40 and above from developing and developed nations alike because it causes difficulties with reading and with accomplishing near vision tasks. Non-invasive methods of correcting presbyopia have been used for many years. While bifocal or multifocal progressive addition lenses, monofocal or bifocal contact lenses can provide satisfactory distance and near vision to presbyopes without the potential risks of a surgical procedure, they cannot restore or substitute the true process of accommodation of a younger individual. Among the surgical options, presbyopia correction can be achieved with excimer or femtosecond laser ablation on cornea (LASIK, PRK, Presbylasik, Supracor, Intracor, etc.), Another recent corneal approach is the insertion of inlays, both artificial and made of corneal tissue in order to change the central curvature of the cornea. Lens extraction with implantation of multifocal, monofocal (monovision) or accommodative intraocular lenses is another method for correction of presbyopia, and has started to become the preferred method for presbyopic correction, particularly in a cataract-aged population. Increasingly, trifocal IOLs – offering correction for near, intermediate and distance vision – are more frequently used.

Purpose:

To evaluate and compare the visual performance of two different trifocal intraocular lens in terms of quality of vision and verify the safety profile

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Adult patient, 18 years old or older will be enrolled in the study
  • Patient with cataract
  • Calculated IOL power is within the range of the study IOL
  • Patients must sign and be given a copy of the written Informed Consent form
  • Clear intraocular media other than cataract
  • Patient willing to undergo the investigations and comply with the follow-up schedule
  • Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study.

排除标准

  • Previous intraocular or corneal surgery
  • Traumatic cataract
  • Pregnancy or lactation
  • Concurrent participation in another drug or device investigation
  • Instability of keratometry or biometry measurements
  • Irregular astigmatism
  • More than 1 D of pre-operative corneal astigmatism.

结局指标

主要结局

Uncorrected Intermediate Visual Acuity (UIVA) (Photopic)

时间窗: Measured at Time frame: | Monocular | Post-operative: 120-180 days, 330-420 days | Binocular: Post-operative 330-420 days]

次要结局

未报告次要终点

研究者

发起方
Biotech vision care pvt ltd
申办方类型
Pharmaceutical industry-Indian
责任方
Principal Investigator
主要研究者

Dr Shreyas Ramamurthy

The Eye Foundation

研究点 (1)

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