JPRN-UMIN000002135未知未知
A study of the AcuFocus(TM) KAMRA(TM) Corneal Inlay implanted intra-stromally in presbyopic patients - A study of the AcuFocus(TM) KAMRA(TM) Corneal Inlay implanted intra-stromally in presbyopic patients
Japanese Research Center of Refractive Surgery0 个研究点目标入组 1,000 人开始时间: 2009年6月29日最近更新:
适应症
试验速览
- 阶段
- 未知
- 发起方
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40years-old 至 65years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Active or recurrent ocular pathology, including eyelid disease, corneal abnormalities (e.g. keratoconus, endothelial dystrophy), cataracts, glaucoma, ocular hypertension, macular degeneration, retinal detachment or any other ocular pathology that would prevent an acceptable visual outcome in the eye to be implanted 2. With a history of steroid-responsive rise in intraocular pressure. 3. Dry eye as determined by objective testing. 4. Using systemic medications with significant ocular side effects, including medications known to exacerbate or induce moderate to severe dry eye. 5. Abnormal threshold visual field. 6. With a history of herpes zoster or herpes simplex keratitis. 7. With a history of diagnosed diabetes, diagnosed autoimmune disease, connective tissue disease, or clinically significant atopic syndrome. 8. Chronic systemic corticosteroids or other immunosuppressive therapy that may affect wound healing, and any immunocompromised patients. 9. Using ophthalmic medication(s) other than artificial tears for treatment of any ocular pathology including ocular allergy. 10. Sensitivity to planned study concomitant medications.
研究者
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