Post-approval Study of VisionCare's Implantable Miniature Telescope (by Dr. Isaac Lipshitz) in Patients With Bilateral Severe to Profound Central Vision Impairment Assoc. With End-stage Age-related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 770
- 试验地点
- 31
- 主要终点
- Long term safety study of implantable miniature telescope
研究概览
简要总结
The objective of the PAS-01 study is to assess the safety of the intraocular as measured by the cumulative incidence of patients who within 5 years after implantation experience persistent vision-impairing corneal edema (corneal edema leading to persistent loss of best corrected distance visual acuity >2 lines from pre-surgery baseline level).
The study will test the null hypothesis that the percentage of patients who experience persistent vision-impairing corneal edema is >17% against the alternative that the percentage is <17%. The null hypothesis will be rejected if the upper bound of the two-sided 95% confidence integral for the observed percentage is <17%.
详细描述
ECD sub-study. At investigative sites participating in the ECD Sub-Group study, corneal endothelial cell density will be measured by non-contact specular microscopy in a subgroup of 150 patients enrolled in the IMT-PAS-01 in the eye schedule for and implanted with the intraocular telescope at study entry, 3 months, 12, months, 24 months, 36 months, 48 months and 60 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •stable severe (BVDCA of 10/160 or poorer) to profound (BCDVA of 20/800 or better) vision impairment caused by bilateral central scotomas associated with end-stage age-related macular degeneration.
- •65 years of age or older
- •retinal findings of geographic atrophy or disciform scar with foveal involvement
- •visually significant cataract
- •agree to undergo pre- and post-surgery training and assessment
- •achieve at least a 5-letter improvement with external telescope
- •have adequate peripheral vision in the eye not scheduled for surgery
排除标准
- •Stargardt's macular dystrophy
- •Anterior chamber depth < 3.0mm
- •Presence of corneal guttate
- •Do not meet minimum age and endothelial cell density requirements
- •evidence of CNV or treatment of CNV within the past 6 months
- •cognitive impairment that would interfere with ability to understand and complete Acceptance of Risk and Informed Decision Agreement or prevent proper training/rehabilitation
- •previous intraocular or cornea surgery of any kind in operative eye, including any type of surgery for either refractive or therapeutic purposes or who have prior or expected ophthalmic related surgery within 30 days preceding intraocular telescope surgery
- •history of steroid-responsive rise in intraocular pressure, uncontrolled glaucoma, or preoperative IOP >22 mm Hg while on maximum medication
- •known sensitivity to post-operative medications
- •history of eye rubbing or an ocular condition that predisposes eye rubbing
- •myopia >6.0 D
- •hyperopia >4.0D
- •axial length <21mm
- •narrow angle, i.e., <Schaffer grade 2
- •cornea stromal or endothelian dystrophies, including guttate
- •inflammatory ocular disease
- •zonular weakness/instability of crystalline lens, or pseudoexfoliation
- •diabetic retinopathy
- •untreated retinal tears
- •retinal vascular disease
- •optic nerve disease
- •history of retinal detachment
- •intraocular tumor
- •retinitis pigmentosa
结局指标
主要结局
Long term safety study of implantable miniature telescope
时间窗: 5 years after implantation
Number of persistent vision impairing corneal edema adverse events
次要结局
未报告次要终点