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临床试验/CTRI/2022/01/039218
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

发起方
BIOTECH EUROPE MEDITECH

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