CTRI/2024/01/061967尚未招募4 期
A Prospective, Single arm, post-marketing clinical study to assess visual performance and safety of OPTIFLEX TRIO Intraocular lens following bilateral implantation. - NI
Tirupati Eye Centre and research Institute0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Adult patient, 18 years old or older will be enrolled in the study
- •2. Patient with cataract
- •3. Calculated IOL power is within the range of the investigational IOL
- •4. Patients must sign and be given a copy of the written Informed Consent form
- •5. Clear intraocular media other than cataract
- •6. Patient willing to undergo the investigations and comply with the follow-up schedule
- •7. 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
- •1. Previous intraocular or corneal surgery
- •2. Traumatic cataract
- •3. Pregnancy or lactation
- •4. Concurrent participation in another drug or device investigation
- •5. Instability of keratometry or biometry measurements
- •6. Irregular astigmatism
- •7. More than 1 D of pre-operative corneal astigmatism
研究者
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