A Prospective, Single arm, post-marketing clinical study to assess visual performance and safety of OPTIFLEX TRIO Intraocular lens following bilateral implantation.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Uncorrected Intermediate Visual Acuity (UIVA) (Photopic)
研究概览
简要总结
Objective:
To evaluate the visual performance of the Optiflex Trio trifocal intraocular lens in terms of quality of vision and verify the safety profile.
The rationale of this study is to obtain safety and efficacy data for the OPTIFLEX TRIO intraocular lens for cataract patients. Trifocal diffractive lenses were developed to address the intermediate vision limitations of bifocal IOL designs. To reduce the likelihood of increasing visual disturbances the designs were such that the dioptric power of the near focal point was twice the dioptric power of the intermediate focal point. In this way the second harmonic of the intermediate focal point contributed to the usable light energy at the near point. The FineVision® (FV) IOL (PhysIOL, Liège, Belgium) is an example of this trifocal design.6,7 The present study aimed to evaluate visual acuities (distance, intermediate and near), refractive changes, contrast sensitivity, defocus curve, and postoperative satisfaction of a new diffractive trifocal IOL (Optiflex TRIO).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 investigational 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: Post-operative: 120-180 days
次要结局
- Visual Acuity, Subjective Refraction,Intraocular Pressure, Keratometry, Corneal Status, Signs of Inflammation([Time Frame: Pre-operative, Postoperative 1-2 days, 7-14 days, 30-60 days, 120-180 days and 330-420 day])
研究者
Dr Mohita Sharma
Tirupati Eye Centre and research Institute