NL-OMON54164招募中不适用
Restoration of central vision with the PRIMA System in Patients with Atrophic Age-Related Macular Degeneration - PRIMAvera
Pixium Vision SA0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
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
- •A subject will be included in the study provided he or she:
- •Is 60 years or older at the date of inclusion*
- •Has a confirmed diagnosis of geographic atrophy due to AMD in both eyes*
- •The study eye has best corrected visual acuity of logMAR 1.2 (20/320) or
- •worse as measured by ETDRS test*
- •Has an atrophic patch in the study eye including the fovea of at least the
- •implant size (>4.5mm^2 and >2.4 mm in minimum diameter)*
- •Understands the constraints of the study and accepts to present for all
- •scheduled follow up visits*
- •Patient signed informed consent.
排除标准
- •A subject will be excluded from the study if he or she:
- •Has cataract in the study eye (with LOCS III scale NO, NC, C or P>1)* (these
- •patients will be asked to have cataract surgery performed prior to enrollment*
- •all other patients will get IOL replacement during the PRIMA implantation)*
- •Underwent intra ocular lens implantation in the study eye within the last
- •Has a highly myopic study eye (>26 mm AP)*
- •Has a highly hyperopic study eye (<20 mm AP)*
- •Has no light perception in either eye*
- •Has a history of documented choroidal neovascularization in either eye*
- •Has any signs of exudative AMD including exudative AMD with detachment of
- •retinal pigment epithelium in the central visual field of the study eye*
- •Has an implanted telescope in one eye*
- •Has a black IOL in the study eye*
- •Has any disease (other than study allowed diseases) or condition that affects
- •retinal function of the study eye or the visual system (e.g., central retinal
- •artery/vein occlusion, end-stage diabetic retinopathy, Proliferative Diabetic
- •Retinopathy (PDR), diabetic macular edema (DME), severe Non-Proliferative
- •Diabetic Retinopathy (NPDR), retinal detachment, infectious or inflammatory
- •retinal disease, severe glaucoma, optic neuropathy, etc.)
- •Has any disease or condition that prevents adequate examination (including
- •OCT) of the study eye including, but not limited to media opacities that cannot
- •be resolved prior to implantation. Note, that this criterion is also important
- •for the function of the implant*
- •Has a corneal endothelial cell count of less than 1000 cells/mm² in the study
- •Suffers from nystagmus or other ocular motility disorders*
- •Has any disease or condition that precludes the understanding or
- •communication of the informed consent, study requirements or test protocols
- •(e.g., deafness, severe multiple sclerosis, amyotrophic lateral sclerosis,
- •severe neuritis, etc.)*
- •Has epileptic seizures*
- •Has a known sensitivity to the contact materials of the implant (iridium
- •oxide, siliconcarbide and titanium)*
- •Has a known allergy to anesthetic drugs*
- •Presents with hypotonia in the study eye (<8 mmHg)*
- •Presents with hypertonia in the study eye (>23 mmHg with treatment)*
- •Has active cancer or a history of intraocular, optic nerve or brain cancer
- •and metastasis*
- •Is an immune-suppressed subject (e.g., due to HIV positive diagnosis, etc.)*
- •Is a known carrier of multi-resistant microorganisms*
- •Is receiving anticoagulation therapy that cannot be adapted to allow eye
- •Is participating in another investigational drug or device study that may
- •interfere with the PRIMAvera study*
- •Has a history of chronic or recurrent infection or inflammation that would
- •preclude participation in the study*
- •Has significant recurrent or chronic inflammations or infections.
- •Specifically, patients with the following disorders are excluded:
- •- Severe chronic and consuming diseases that frequently associated with
- •infection (e.g. Crohn disease, Whipple*s disease)*
- •- Active inflammation in the area of the eye (e.g. herpes of cornea and/or
- •conjunctiva, recurrent blepharoconjunctivitis, hordeolum, chalazion)*
- 另有 3 项未显示
研究者
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