A prospective, comparative, randomized post-marketing clinical study to evaluate the safety, efficacy and refractive outcome of two different toric Intraocular Lens implanted into patients with cataract and corneal astigmatism.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 276
- 试验地点
- 2
- 主要终点
- 1. Rotational Stability,
研究概览
简要总结
Primary Objectives: To compare and evaluate two different Toric intraocular lenses for spherical and astigmatic correction, and rotational stability in cataract surgery.
Secondary Objectives: To assess and compare the safety of two different Toric intraocular lenses.
Below changes in protocol version 1.o to 1.1
| **Change | ||||
| Summary** |
|Sr No.
Previous Version
Description
Current Version
Description
|1.
1.0
Keratometry Value not added in Visit 2, 3, 4 and 5
1.1
Added Keratometry value in visit 2 , 3, 4 and 5
|2.
Astigmatism Not added in Visit 5
Astigmatism added in visit 5
|3.
Pupil size not mentioned in visit 2
Pupil size added in visit 2.
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
- •Unilateral and Bilateral Implantation BCVA to be 0.2 Log Mar or Lower Power withing the range of Investigational IOL Stability of the cornea Patients who have and will attend all follow-up appointments Patients must sign and be given a copy of the written Informed consent form.
排除标准
- •Preoperative ocular pathology
- •Ocular co-morbidities affecting visual outcome
- •Previous intra ocular or corneal surgery
- •Traumatic cataract
- •Corneal Opacities
- •Irregular astigmatism
- •instability of keratometry or biometry measurements;
- •Ophthalmic diseases such as Pseudoexfoliation, glaucoma, traumatic cataract corneal scars and other co-morbidity that could affect capsule bag stability.
结局指标
主要结局
1. Rotational Stability,
时间窗:  Visit 1- Post-operative Day 1-2 |  Visit 2- Post-operative Day 7-14 |  Visit 3- Post-operative Day 30-60 |  Visit 4- Post-operative Day 120 to 180 |  Visit 5-Post-operative Day 330 to 42
2. Corrected and Uncorrected Visual Acuity
时间窗:  Visit 1- Post-operative Day 1-2 |  Visit 2- Post-operative Day 7-14 |  Visit 3- Post-operative Day 30-60 |  Visit 4- Post-operative Day 120 to 180 |  Visit 5-Post-operative Day 330 to 42
3. Refraction and Refractive Astigmatism
时间窗:  Visit 1- Post-operative Day 1-2 |  Visit 2- Post-operative Day 7-14 |  Visit 3- Post-operative Day 30-60 |  Visit 4- Post-operative Day 120 to 180 |  Visit 5-Post-operative Day 330 to 42
4. Spherical Equivalence
时间窗:  Visit 1- Post-operative Day 1-2 |  Visit 2- Post-operative Day 7-14 |  Visit 3- Post-operative Day 30-60 |  Visit 4- Post-operative Day 120 to 180 |  Visit 5-Post-operative Day 330 to 42
5. Introcular pressure
时间窗:  Visit 1- Post-operative Day 1-2 |  Visit 2- Post-operative Day 7-14 |  Visit 3- Post-operative Day 30-60 |  Visit 4- Post-operative Day 120 to 180 |  Visit 5-Post-operative Day 330 to 42
6. Change in Endothelial Cell count
时间窗:  Visit 1- Post-operative Day 1-2 |  Visit 2- Post-operative Day 7-14 |  Visit 3- Post-operative Day 30-60 |  Visit 4- Post-operative Day 120 to 180 |  Visit 5-Post-operative Day 330 to 42
次要结局
- Secondary Surgery due to early onset of PCO(3, 6 & 12 Months post surgery)
研究者
Dr Samar Kumar Basak
Disha eye Hospitals