Assessment of visual performance of a new trifocal intraocular lens for visual quality and safety (Optiflex TRIO, Biotech Europe Meditech Inc. Ltd.)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 2. quality of vision
研究概览
简要总结
This study is being conducted to evaluate the visual performance of a Trifocal Intraocular lens which has become recently available in India for correction of presbyopia after cataract extraction. The study is a post marketing clinical surveillance
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient with bilateral age related senile cataract
- •grade of cataract permitting optical biometry
- •no ocular/systemic contraindication for surgery
- •a patient with preoperative corneal astigmatism less than 1D in each eye
- •normal macular functions with normal anantomy of macula as seen on optical coherence tomography
- •no history or evidence of ocular anatomical or functional disorders other than cataract including strabismus neuro-ophthalmological disorders of optic nerve or high visual functions corneal pathologies disorders of uvea vitreous pathologies retinal disorders
- •no systemic contraindications to surgery under local anaesthesia
- •patient willing to undergo the investigations and comply with the follow-up schedule.
排除标准
- •cataract precluding optical biometry
- •posterier-segment pathology
- •media opacity other than cataract
- •corneal higher order aberrations more than 0.3 micron as measured on ray-tracing wavefront aberrometer
- •patients with potential for intraoperative complications such as floppy iris syndrome and pseudo-exfoliation syndrome
- •cases where intra-operative complications compromise IOL placement with proper centration in the capsule bag
- •patient unwilling to undergo the required investigations or follow-up.
结局指标
主要结局
2. quality of vision
时间窗: 1. Pre-operative visit | 2. Operative visit | 3. Post-operative visit 1 - Day 1 | 4. Post-operative visit 2 - 1 month | 3. Post-operative visit 3 - 3 months | 3. Post-operative visit 4 - 6 months | 3. Post-operative visit 5 - 12 months
uncorrected and best corrected distance intermediate and near visual acuity
时间窗: 1. Pre-operative visit | 2. Operative visit | 3. Post-operative visit 1 - Day 1 | 4. Post-operative visit 2 - 1 month | 3. Post-operative visit 3 - 3 months | 3. Post-operative visit 4 - 6 months | 3. Post-operative visit 5 - 12 months
1. visual acuity
时间窗: 1. Pre-operative visit | 2. Operative visit | 3. Post-operative visit 1 - Day 1 | 4. Post-operative visit 2 - 1 month | 3. Post-operative visit 3 - 3 months | 3. Post-operative visit 4 - 6 months | 3. Post-operative visit 5 - 12 months
次要结局
未报告次要终点