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临床试验/DRKS00000077
DRKS00000077已完成3 期

Intrastromal Correction of Ametropia by a Femtosecond Laser - ISCAF

Technolas Perfect Vision GmbH0 个研究点目标入组 86 人开始时间: 2009年4月14日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
86

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 one(—)
性别
All

入选标准

  • age: > 18 years
  • - stable distance refraction for at least one year (i.e. a maximum change of 0.5 D)
  • - in the case of presbyopia: minimum near add +2D to + 4D
  • - in the case of myopia or hyperopia (without astigmatism): minimal 1D and maximum 3D
  • - in the case of myopia or hyperopia (with astigmatism):
  • spherical equivalent of minimal 1D and maximum 3D
  • - BSCVA of the eye to be treated >= 0.63
  • - patients are willing and in such conditions to come to the follow-up exams
  • - no further ocular pathologies

排除标准

  • - age: < 18 years
  • - refraction less than +/- 1 D or higher than +/- 3 D (not valid for persbyopia patients)
  • - minimal pachymetry of < 500µm
  • - K-mean < 37 D or > 60 D
  • - Difference (K-max minus K-min) > 5D
  • - Difference cycloplegic refraction to subjective refrection more than 1 D (valid only for hyperopia correction)
  • - patients with previous intraocular or corneal surgeries (e.g. post-LASIK or PRK patients). Examption: standard cataract surgery.
  • - patients with one or more of the following ocular pathologies:
  • > keratokonus
  • > corneal scars
  • > transplanted cornea
  • > disorders of wound healing
  • > glaucoma
  • > epilepsia
  • > nystygmus
  • > lack of concentration
  • > other complicated illnesses
  • > diabetis mellitus
  • > instable K-readings as a sign of instable cornea
  • > weakness of connective tissue
  • > sensitivity against the drugs used in the study
  • > continous wearing of contact lenses before the pre-exam, and before the surgery. At least 14 days before these dates patients must abstain from wearing CL.
  • > patients in pregnancy or during lactation
  • > patients who take part in an other clinical trial

研究者

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