A Prospective, Multicenter Post-marketing Clinical Investigation of the SING IMT(TM) System, Model NG SI IMT 3X in Patients With Central Vision Impairment Associated With End-stage Age-related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 13
- 主要终点
- Safety of the SING IMT System, model NG SI IMT 3X, including its delivery system
研究概览
简要总结
The objective of this study is to demonstrate the safety and effectiveness of the SING IMT (Smaller Incision New Generation Implantable Miniature Telescope) 3X implant in improving vision in patients with central vision impairment associated with end-stage Age-related Macular Degeneration (AMD).
Eligible patients will be implanted with the SING IMT device and will be followed-up for a period of 12-months with post-operative ophthalmic exams and low-vision rehabilitation sessions.
详细描述
This is an interventional, prospective, multicenter, open label, single group assignment Post-Market Clinical Follow-up (PMCF) study in men and women >=55 years with central vision impairment associated with end-stage AMD.
Following completion of informed consent, patients will be evaluated for eligibility to enroll into the study. Baseline visual acuity of the study subjects will be assessed with a 2.8X external telescope simulator (ETS) using Early Treatment Diabetic Retinopathy Study (ETDRS) charts to determine if they are likely to benefit from receiving the IMT. To be included in the study and to proceed with the surgery, subjects must achieve, using the ETS, at least a one line (5 or more letters) improvement in distance on the ETDRS chart in the eye scheduled for surgery. Subjects not meeting these criteria will be excluded from the study.
If eligible, they will be scheduled for out-patient surgery to implant the IMT during routine cataract surgery.
Postoperatively, the surgeon will complete a usability and satisfaction questionnaire after each implantation procedure.
The patients will undergo ophthalmic evaluations in both eyes at regular intervals for up to 12 months. The subjects will also be required to undergo 6 to 10 additional visits for vision training with a low vision specialist.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 55 years of age or older.
- •Have retinal findings of geographic atrophy or disciform scar with foveal involvement as determined by fluorescein angiography or OCT.
- •Have evidence of cataract.
- •Have best-corrected distance visual acuity (BCDVA) no better than 20/80 (0.6 LogMAR) and no worse than 20/800 (1.6 LogMAR) in both eyes.
- •Have adequate peripheral vision in the eye not scheduled for surgery, assessed by observation of ambulation.
- •Achieve at least a five-letter improvement on the ETDRS chart in the eye scheduled for surgery when using Samsara's 2.8X external telescope simulator (ETS, supplied separately).
- •Have an ACD of at least 2.5 mm in the eye scheduled for surgery.
- •Be willing to participate in a post-operative training program for the use of the NG SI IMT 3X implant.
- •Review and sign the Independent Ethics Committee (IEC)-approved Informed Consent Form (ICF) prior to any study-related procedures being performed.
- •Have adequate understanding of the local language to understand verbal and written subject information and be willing to comply with the study requirements.
排除标准
- •Evidence of active choroidal neovascularization (CNV) on fluorescein angiography or OCT or were treated for CNV within the past six months.
- •Any ophthalmic pathology that compromises the patient's peripheral vision in the fellow eye.
- •A history of steroid-responsive rise in IOP, uncontrolled glaucoma, or preoperative IOP>22 mm Hg.
- •Corneal guttata.
- •Known sensitivity to post-operative medications.
- •Significant communication impairment or severe neurological disorders.
- •Have undergone previous intraocular or corneal surgery of any kind in the operative eye, including any type of surgery for either refractive or therapeutic purposes.
- •An ocular condition that predisposes the patient to eye rubbing.
- •Prior or expected ophthalmic-related surgery within 30 days preceding the NG SI IMT 3X implant surgery.
- •Patients for whom the planned operative eye has:
- •Myopia > 6.0 D
- •Hyperopia > 4.0 D
- •Axial length < 21 mm
- •Endothelial cell density < 1600 cells per square mm
- •Narrow angle, i.e., < Schaffer grade
- •Inflammatory ocular disease.
- •Cornea stromal or endothelial dystrophies, including guttata.
- •Zonular weakness/instability of crystalline lens, or pseudoexfoliation.
- •Diabetic retinopathy.
- •Untreated retinal tears.
- •Retinal vascular disease.
- •Optic nerve disease.
- •A history of retinal detachment.
- •Retinitis pigmentosa.
- •Intraocular tumor.
- •Have received any investigational product within 30 days prior to study enrollment or be planning to participate in another investigation during the course of this study.
- •Be an employee (or a relative of an employee) of the contract research organization (CRO) responsible for conducting the study, Sponsor, or Sponsor representative.
- •Have a condition or be in a situation that, in the Investigator's opinion, may put the Subject at significant risk, may confound the study results, or may interfere significantly with the Subject's participation in the study.
研究组 & 干预措施
SING IMT System model NG SI IMT 3X
All participants will be implanted with the SING IMT System model NG SI IMT 3X.
干预措施: SING IMT(TM) System, model NG SI IMT 3X (Device)
结局指标
主要结局
Safety of the SING IMT System, model NG SI IMT 3X, including its delivery system
时间窗: 12 months
The percent decrease in endothelial cell density (ECD).
次要结局
- Improvement in near and distance best corrected visual acuity (BCVA) in implanted eyes.(12 months)
- Usability of SING IMT System, including delivery system(12 months)
- Incision size needed for device implantation(12 moths)
- Surgical complications(12 moths)