DRKS00005742已完成未知
Post-market clinical follow-up investigation of the marketed Extended Range of Vision IOL (Intraocular lens) - EROV-108-COMP
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 147
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
- N/a: Single Arm 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
- •· Minimum 22 years of age
- •· Planned natural lens replacement with posterior chamber IOL implantation
- •· Visual potential of 20/25 or better in the operative eye following natural lens
- •replacement with an IOL
- •· Normal corneal topography
- •· Clear intraocular media other than cataract in each eye
- •· Availability, willingness, sufficient cognitive awareness to comply with examination
- •· Ability to sign informed consent
排除标准
- •· Requiring an intraocular lens power outside the available range of +16.0 D to
- •· Patients with recurrent severe anterior or posterior segment inflammation or uveitis
- •of unknown etiology, or any disease producing an inflammatory reaction in the eye
- •· Patients in whom the intraocular lens may affect the ability to observe, diagnose or
- •treat posterior segment diseases
- •· Expected surgical difficulties at the time of cataract extraction, which may increase
- •the potential for complications (e.g., persistent bleeding, significant iris damage,
- •uncontrolled positive pressure or significant vitreous prolapse or loss)
- •· A compromised eye due to previous trauma or developmental defects in which
- •appropriate support of the IOL is not possible
- •· Circumstances that would result in damage to the endothelium during implantation
- •· Suspected microbial infection
- •· Patients in whom neither the posterior capsule nor the zonules are intact enough
- •to provide support for the IOL
- •· Congenital bilateral cataracts
- •· Previous history of, or a predisposition to, retinal detachment
- •· Patients with only one good eye with potentially good vision
- •· Medically uncontrollable glaucoma
- •· Corneal endothelial dystrophy
- •· Proliferative diabetic retinopathy
- •· Patient is pregnant, plans to become pregnant, is lactating or has another
- •condition associated with the fluctuation of hormones that could lead to refractive
- •· Concurrent participation or participation within 30 days prior to preoperative visit in
- •any other clinical trial
研究者
相似试验
已完成
不适用
Post-market clinical follow-up study evaluating the efficacy and safety of the wearable cardioverter-defibrillator (WCD) medical device 'LifeVest' in real-life settings in FranceISRCTN91372291ZO550
招募中
不适用
A post market clinical follow-up study with the aneXys ceramys inlay DEM16.7M16.1Other secondary coxarthrosisOther primary coxarthrosisDRKS00018809Mathys Orthopädie GmbH150
已完成
不适用
A post market clinical follow-up study with the aneXys acetabular cup and ceramys inlayM16.1M16.7Other primary coxarthrosisOther secondary coxarthrosisDRKS00021508Mathys AG Bettlach150
进行中（未招募）
不适用
Post-market clinical follow-up study to evaluate the performance and safety of Suprasorb® A + Ag wound dressing and rope in the treatment of chronic woundsPresence of a chronic wound according to the instruction for use:- venous leg ulcer or- arterial ulcer (ABPI > 0,5) or- arterial and venous leg ulcer (ABPI > 0,5) or- pressure ulcer (category II – IV) or- diabetic foot ulcer or- post-operative wound healing disturbance or- donor sites or mesh graphsL89.1L89.2L89.3Stage II decubitus ulcerStage III decubitus ulcerStage IV decubitus ulcerDRKS00014861ohmann & Rauscher GmbH & Co. KG9
招募中
4 期
Thigh bone fracture and its union by using different implants studyCTRI/2024/01/061265Auxein Medical Pvt Ltd