CTRI/2022/01/039218招募中4 期
Assessment of visual performance of a new trifocal intraocular lens for visual quality and safety (Optiflex TRIO, Biotech Europe Meditech Inc. Ltd.)
BIOTECH EUROPE MEDITECH0 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
- 招募中
- 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. Patient with bilateral age related senile cataract
- •2. grade of cataract permitting optical biometry
- •3. no ocular/systemic contraindication for surgery
- •4. a patient with preoperative corneal astigmatism less than 1D in each eye
- •5. normal macular functions with normal anantomy of macula as seen on optical coherence tomography
- •6. 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
- •7. no systemic contraindications to surgery under local anaesthesia
- •8. patient willing to undergo the investigations and comply with the follow-up schedule
排除标准
- •1. cataract precluding optical biometry
- •2. posterier-segment pathology
- •3. media opacity other than cataract
- •4. corneal higher order aberrations more than 0.3 micron as measured on ray-tracing wavefront aberrometer
- •5. patients with potential for intraoperative complications such as floppy iris syndrome and pseudo-exfoliation syndrome
- •6. cases where intra-operative complications compromise IOL placement with proper centration in the capsule bag
- •7. patient unwilling to undergo the required investigations or follow-up
研究者
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