A Prospective, Open-label, Single Arm Study to Evaluate the Safety and Effectiveness of the EndoArt® in Subjects With Chronic Corneal Edema in Whom Multiple Prior Keratoplasty (EK/PK) Have Failed, and Who Are Not Reasonable Candidates for Any Form of Corneal Transplant, Including Penetrating Keratoplasty
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 123
- 主要终点
- The rate of any device related SAE
研究概览
简要总结
The EndoArt® device is intended to treat patients with chronic corneal edema due to endothelial dysfunction, in whom prior multiple keratoplasty (EK/PK) have failed, and who are not reasonable candidates for any form of corneal transplant, including penetrating keratoplasty.
The EndoArt® (Corneal Artificial Endothelial layer) is a permanent synthetic implant. It is made of a clear, transparent, foldable, biologically compatible hydrophilic copolymer. The device serves as an inert physical barrier, blocking the ingress of fluid from the Anterior Chamber (AC) into the cornea.
详细描述
The study is a prospective, multi-center, open-label, single arm pivotal clinical investigation. The objective is to evaluate the safety and effectiveness of EndoArt® implantation in subjects with chronic corneal edema, in whom multiple prior keratoplasty (EK/PK) procedures have failed, and who are not reasonable candidates for any form of corneal transplant, including penetrating keratoplasty.
Safety will be assessed by evaluating the rate of any device related SAE occurred through the 12-month follow-up period.
The primary effectiveness endpoint is the proportion of subjects achieving an improvement in visual acuity of at least 0.20 LogMAR for subjects with baseline BCVA better than 1.30 LogMAR, or an improvement to at least 1.30 LogMAR for subjects with baseline BCVA equal or worse than 1.30 LogMAR, at 12 months postoperatively.
Subjects with chronic corneal edema, in whom multiple prior keratoplasty (EK/PK) have failed, and who are not reasonable candidates for any form of corneal transplant, including penetrating keratoplasty will be the study target population.
Only subjects who have signed the informed consent form and meet all the eligibility criteria listed below will be qualified for enrollment. The study will include a total of 123 surgically treated subjects. This clinical investigation will be conducted in a maximum of fifteen (20) clinical sites in the USA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects 30-85 years of age.
- •Have chronic corneal edema (lasting at least 3 months) and have experienced at least 3 prior keratoplasty (EK/PK) failures.
- •Is not a reasonable candidate for any form of corneal transplant, including penetrating keratoplasty.
- •CCT of 650-1200 μm, not including DSAEK thickness.
- •* In cases where the treated eye has undergone PKP, or if the corneal thickness of the contralateral eye cannot be measured (e.g., monocular patient, or if the contralateral eye has corneal edema or a history of PKP), the CCT of the study eye must be between 700-1200 μm.
- •Pseudophakia
- •Cornea WTW between 10-13 mm
- •IOP <20 mmHg and IOP≥8 mmHg
- •BCVA of the study eye equal or worse than 0.50 LogMAR and up to 2.40 LogMAR (Hand motion is between 2.20-2.40 LogMAR).
- •Must have better visual acuity in the contralateral eye, which must be at least 0.20 LogMAR better than the treated eye and have a visual acuity of at least 1.00 LogMAR.
- •Central general clarity grade ≥2 (See Table
- •Central general clarity grading)
- •Willing and able to understand and sign informed consent prior to any study-related procedure.
- •Willing and able to follow study instructions (e.g., to lay on one's back for at least 4 hours post op.), able to self-administer or have caregiver available to administer eyedrops as required by the protocol for the duration of the study, and able to attend study visits/assessments for the duration of the study.
排除标准
- •No light perception or light perception.
- •Opaque scar in the visual axis that is indicated for PKP.
- •Irregular posterior cornea (e.g. post trauma) in the 6.5 mm central part of the cornea (EndoArt® diameter).
- •Current infection of the cornea.
- •Central Band keratopathy and/or limbal stem cell deficiency.
- •Diagnosis of: Sjogren's Syndrome, GVHD.
- •PUK (peripheral ulcerative keratitis)
- •Phthisis bulbi or subject is at high risk of developing phthisis (Hypothony).
- •History of corneal refractive surgery: LASIK, PRK, SMILE, Epi-keratoplasty (or any anterior lamellar keratoplasty, inlays) and Radial Keratotomy (RK).
- •Severe corneal distortion e.g.: keratoconus, pellucid marginal degeneration or keratoglobus (not relevant post PKP).
- •Subject with medically uncontrolled intra ocular pressure, which requires surgical intervention.
- •Active inflammation, or active, recurrent, or Chronic Uveitis
- •Dislocation or partial dislocation of the IOL.
- •Have large iris defect (more than 90 degrees) which could compromise intraoperative air bubble formation, excluding inferior defect.
- •Severe ptosis (middle of pupil or covering the pupil entirely).
- •Subject receiving regular intravitreal injection.
- •History of persistent/ recurrent corneal erosion or persistent epithelial defect with difficulties in epithelial re-growth (erosion more than 2 months).
- •History of ocular herpetic keratitis
- •Current retinal detachments
- •Advanced optic nerve cupping (defined as a cup-disc ratio of 0.9 or greater).
- •Posterior segment masses or other acute significant posterior segment pathology (e.g., active age-related macular degeneration or chronic cystoid macular edema).
- •Afferent Pupillary Defect (APD)
- •Fellow eye CCT < 500 µm
- •Any other acute ocular condition
- •Bilateral implantation of the EndoArt®
- •Posterior vitrectomy (anterior vitrectomy is allowed)
- •Subjects with mental impairment
- •Subject with history of spontaneous corneal perforations.
- •Pregnant or lactating women, or with childbirth plans during the clinical trial
- •Currently participating or have participated in an investigational study, other than this study, within the past 60 days.
研究组 & 干预措施
EndoArt® Artificial Endothelial Layer
Implantation of the EndoArt (Artificial Endothelial Layer)
干预措施: The EndoArt® (Corneal Artificial Endothelial layer) (Device)
结局指标
主要结局
The rate of any device related SAE
时间窗: 12 months
SAEs may include, but are not limited to, e.g., secondary surgical intervention, severe infectious keratitis requiring hospitalization, and corneal perforation
Improvement in visual acuity as measured by BCVA
时间窗: 12 months
The proportion of subjects achieving a change in visual acuity of at least 0.20 LogMAR for subjects with baseline BCVA better than 1.30 LogMAR, or a visual acuity of 1.30 LogMAR or better at 12 months postoperatively for subjects with baseline BCVA of 1.30 LogMAR or worse
次要结局
- Distribution of BCVA change(12 months)
- Distribution of BCVA outcomes (using FrACT10)(12 months)
- All AE rate(12 months)
- BCVA Success rate(12 months)
- CCT(12 months)
- Change in manifest refraction(12 months)
- Corneal clarity(12 months)