Prospective, Controlled, Randomized, Masked Unilateral or Bilateral implantation, Single Centre, Clinical investigation study to evaluate Safety and Performance of EDOF (Extended Depth of Focus) IOL (Omni Lens Pvt Ltd) in patients who require EDOF IOL implantation during routine cataract Surgery.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- 1. Best-Corrected distance visual acuity(CDVA)
研究概览
简要总结
Prospective, Controlled, Randomized, Masked Unilateral or Bilateral Implantation, Single Centre Clinical Investigational study of EDOF Hydrophilic Acrylic Foldable IOL (Omni Lens Pvt.Ltd.) in patients who require EDOF Implantation during routine cataract surgery.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Cataract (Unilateral/Bilateral) 2.Calculated EDOF IOL power is within the range of the Study device i.e. 8 to 30 D (+3.00D) 3.The patient or his/her legally authorized representative (if applicable) agrees to provide written informed consent.
- •4.Clear intraocular media other than cataract 5.The patient is willing to comply with protocol specified follow-up evaluations.
- •#If any of the above criteria is answered ‘No’, the subject may not be enrolled in the study.
排除标准
- •Previous intraocular or corneal surgery
- •Traumatic cataract and/or existing inflammation
- •Pregnancy or lactation
- •Concurrent participation in another drug or device investigation
- •At the time of surgery conditions such as zonular instability, need for iris manipulation, capsular fibrosis or other opacity and inability to fixate EDOF IOL in desired position.
- •Instability of keratometry or biometry measurements
- •Irregular astigmatism
- •History of intraocular Inflammation
- •Subjects who may be reasonably expected to require secondary surgical intervention at any time during the investigation (other than YAG capsulotomy).
- •Gonioscopy Abnormalities
- •More than 1 D of pre-operative corneal astigmatism
- •Minor under the age of 18
- •Those who are participating in other clinical trials of drugs or medical devices.
- •# If any of the above criteria is answered ‘YES’, the subject may not be enrolled in the study.
结局指标
主要结局
1. Best-Corrected distance visual acuity(CDVA)
时间窗: 1. Best-Corrected Distance Visual Acuity (CDVA) [Time frame: At Baseline, 1 week,4 weeks and 18 weeks) | 2.Distance –corrected Intermediate visual Acuity (DCIVA) [Time frame: 4weeks and 18 weeks] | 3.Distance –corrected Near visual Acuity (DCNVA) [Time frame: 4 weeks and 18 weeks]
2. Distance -corrected intermediate visual acuity(DCIVA)
时间窗: 1. Best-Corrected Distance Visual Acuity (CDVA) [Time frame: At Baseline, 1 week,4 weeks and 18 weeks) | 2.Distance –corrected Intermediate visual Acuity (DCIVA) [Time frame: 4weeks and 18 weeks] | 3.Distance –corrected Near visual Acuity (DCNVA) [Time frame: 4 weeks and 18 weeks]
3. Distance-corrected near visual acuity(DCNVA)
时间窗: 1. Best-Corrected Distance Visual Acuity (CDVA) [Time frame: At Baseline, 1 week,4 weeks and 18 weeks) | 2.Distance –corrected Intermediate visual Acuity (DCIVA) [Time frame: 4weeks and 18 weeks] | 3.Distance –corrected Near visual Acuity (DCNVA) [Time frame: 4 weeks and 18 weeks]
次要结局
- 1. Depth of focus curve Test(2. Adverse event rates)
研究者
Dr Uday R Gajiwala
Divyajyoti Trust- Tejas Eye Hospital