DRKS00000077已完成3 期
Intrastromal Correction of Ametropia by a Femtosecond Laser - ISCAF
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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