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临床试验/CTRI/2015/12/006464
CTRI/2015/12/006464招募中4 期

Femtosecond Laser Assisted Cataract Surgery in Intumescent Cataracts

Alcon laboratories India pvt Ltd0 个研究点目标入组 425 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
入组人数
425

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. Adults, 21 years of age or older who are willing to undergo cataract surgery
  • 2. Able to lie flat in a supine position
  • 3. Able to understand and sign the Informed Consent Form (ICF)
  • 4. Subjects must present with intumescent white cataract, with a liquid pressurized bag
  • and a milky, liquid cortex

排除标准

  • 1. Subjects who refuse to sign the informed consent
  • 2. Pregnant or lactating mothers
  • 3. Corneal disease that precludes application of the cornea or transmission of laser light
  • at 1030 nanometer (nm)wavelength
  • 4. Descemetocele with impending corneal rupture
  • 5. Corneal opacity that would interfere with the laser beam
  • 6. Presence of blood or other material in the anterior chamber
  • 7. Hypotony or presence of corneal implant
  • 8. Poorly dilating pupils, such that the iris is not peripheral to the intended diameter for
  • the capsulotomy
  • 9. Condition which would cause inadequate clearance between the intended capsulotomy
  • depth and the endothelium
  • 10. Residual, recurrent, active ocular or eye lid disease, including any corneal abnormality
  • (for example, recurrent corneal erosion, severe basement membrane disease)
  • 11. A history of lens or zonular instability
  • 12. Any contraindication to cataract surgery
  • 13. Corneal thickness requirements that are beyond the range of the LenSx Laser system
  • (More than 1200 μ)
  • 14. Subjects who in the opinion of the investigator are not good candidates for the trial
  • 15. Subjects whose postoperative best corrected visual potential is expected to be worse
  • than 20/40 Snellen (0.3 logMAR) at the final study visit

研究者

发起方
Alcon laboratories India pvt Ltd

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