DRKS00010594已完成4 期
Interindividual Comparison Trial – Two intraocular lenses with extended depth of focus - IC8 vs. Symfony
niversitätsklinikum Knappschaftskrankenhaus Bochum GmbH Augenklinik0 个研究点目标入组 43 人开始时间: 2016年7月18日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 22 Years 至 one（—）
- 性别
- All
入选标准
- •Visual acuity reducing cataract (LOCS III Grading, 1-5)
- •- Visual acuity <= 0,63 dec
- •- Age >22 year
- •- planned Cataract surgery for both eyes
- •- potential visual acuity after surgery >= 0,8 dec.
- •- clear ocular media, except cataract
- •- voluntary participation in the study
- •- understood and signed informed consent
排除标准
- •- IOL power outside the range of +20.0 D to +27,0 D
- •- Dilated pupil size of less than 6.0 mm
- •- Pupillary abnormalities
- •- microphthalmos
- •- Prior corneal surgery or intraocular surgery
- •- Astigmatism> 0.75 diopters, irregular astigmatism
- •- corneal abnormalities or degenerative disease to reduce the visual acuity during the study to 0.63 or lower
- •- Active inflammation, diseases, pathologies or infection of the anterior or posterior segment of the eye
- •- Glaucoma or ocular hypertension uncontrolled
- •- Congenital cataracts
- •- Initial situations with increased risk of zonula defects (as Pseudoexfoliation or trauma to the eye in the history)
- •- Medication that may affect the visual acuity
- •- Antidepressant or antipsychotic medications
- •- Intraoperative Floppy Iris Syndrome (IFIS) (using alpha-antagonists (for example, tamsulosin)
- •- Acute, chronic or uncontrolled systemic diseases, in the opinion of the examiner an influence on the results of the study (for example, immunosuppression, connective tissue, hypertension, etc.)
- •- Dry eye or the regular use of artificial tears
- •- Poorly controlled diabetes mellitus or insulin-dependent diabetes mellitus
- •- Pregnancy, planned pregnancy or breastfeeding
- •- Current participation or participation in the last 30 days in another study
研究者
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