DRKS00034568已完成不适用
Performance evaluation of a device for preoperative visualisation of the postoperative visual impression - IOL-visualisation-study
ACMIT Gmbh0 个研究点目标入组 35 人开始时间: 2024年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
研究概览
简要总结
For the cases without the use of mydriatics, all hypotheses for visual acuity and contrast sensitivity were confirmed. Thus, the TRAVIS device (without the use of mydriatics) enables the prediction of postoperative visual acuity of better than 0.1 logMAR and for postoperative contrast sensitivity of better than 0.25 logCSWeber.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40 Years 至 one（—）
- 性别
- All
入选标准
- •Clear lens patients (not yet clinically relevant onset of cataract) with short-sightedness, long-sightedness, presbyopia and desire to be spectacle-free;
- •- Visual acuity with visual aid cc = 80 %;
- •- Astigmatism = 3.0 D;
- •- Willingness to participate in the study and willingness to participate in all follow-up visits;
- •- Signed declaration of consent
排除标准
- •* Astigmatism > 3.0 D;
- •* Irregular astigmatism;
- •* Patients with vision-impairing eye diseases (e.g. glaucoma, AMD, corneal opacities or other retinal or optic disorders);
- •* Previous intraocular or corneal surgery;
- •* Traumatic cataract;
- •* Expected complicated surgery;
- •* Pupillary abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions);
- •* In addition, subjects will be dropped if certain conditions are present at the time of surgery, including:
- •- zonular instability;
- •- Capsular fibrosis;
- •- Need for iris manipulation;
- •- Inability to place the IOL in the desired position
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