NL-OMON31010已完成不适用
European multicenter study with the ARTIFLEX Toric PIOL for the correction of astigmatism in phakic eyes - ARTIFLEX Toric
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- OPHTEC BV
- 入组人数
- 27
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
- 年龄范围
- 18 至 99（—）
入选标准
- •- Stable refraction (±0.5 D; ±1.0 D for high refractive errors), as expressed by manifest refraction spherical equivalent (MRSE) for a minimum of 12 months prior to surgery, verified by consecutive refractions and/or medical records or prescription history;
- •- Myopic astigmatism requiring correction within the range of the ARTIFLEX Toric PIOL. The investigators will receive an availability list when it becomes available. The calculated refraction can be 0.25 D lower or higher than the minimum or maximum available lens power for both the cylinder and the sphere (e.g. if the minimum cylinder will be 1.0 D, the minimum cylinder of the patient has to be 0.75 D after calculation);
- •- A minimum BCVA of 0.5 in each eye;
- •- UCVA of 0.5 or worse;
- •- Less than 0.75 D difference between cycloplegic and manifest refractions;
- •- Regular astigmatism.
排除标准
- •Ocular conditions
- •1. Preoperative ocular condition that can predispose for future complications or interfere with the ability to evaluate the safety or effectiveness of the lens;
- •2. Abnormal iris (e.g. bulging or volcano shaped iris; abnormality which would preclude fixation such as aniridia);
- •3. Abnormal cornea (i.e., keratoconus, opaque cornea, scars, or other cornea pathologies resulting in irregular astigmatism);
- •4. Prior intraocular or corneal surgery;
- •5. Monocular vision;
- •6. Amblyopia;
- •7. Insufficient space for the intended implant (ACD < 3.2 mm);
- •8. High preoperative intraocular pressure, > 21 mmHg;
- •9. Abnormal pupil or pupil in low light > 7.0 mm (scotopic light: < 0.05 lux);
- •10. Patients that, when examined preoperatively, are not expected to achieve a postoperative visual acuity of 20/40 or better;
- •11. A minimal endothelial cell density according to the subject*s age:
- •21 to 25 years of age 2800 cells/mm2;
- •26 to 30 years of age 2650 cells/mm2;
- •31 to 35 years of age 2400 cells/mm2;
- •36 to 45 years of age 2200 cells/mm2;
- •> 45 years of age 2000 cells/mm2;
- •12. Surgical difficulty at the time of surgery which might increase the potential for complications;;Non-ocular conditions
- •13. Aged under 18 or above 60;
- •14. Acute or chronic illness that would increase the operative risk or confound the outcome(s) of the study;
- •15. Patients who are immuno-compromised by steroids and/or antimetabolites;
- •16. Subject is taking systemic medications that can confound the outcome of the study or increase the risk to the subject;
- •17. Subject is pregnant, plans to become pregnant, or is lactating during the course of the study, or has another condition associates with the fluctuation of hormones that could lead to refractive changes;
- •18. Diabetic mellitus;
- •19. Mentally retarded;
- •20. Patients that are not able to meet the extensive postoperative evaluation requirements;
研究者
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