Multicenter Clinical Trial to Evaluate the Safety and Efficacy of Ex Vivo Corneal Cross-linking of Donor Corneal Tissue Used for Vascularized High-risk Keratoplasty
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 24
- 主要终点
- Determining the Primary Safety of Corneal Cross Linking
研究概览
简要总结
The main objective of this study is to determine the safety of Ex Vivo Cross Linking (CXL) of donor corneal tissue in participants who have undergone high-risk penetrating keratoplasty.
详细描述
This is a randomized, double-masked, multi site clinical trial to determine the safety of Ex Vivo CXL of donor corneal tissue in 96 participants who have undergone high-risk penetrating keratoplasty.
Participants will be randomized to receive either a corneal tissue that has been untreated vs. a corneal tissue that has been treated with Photrexa® Viscous & Photrexa® and UV light. The tissue will be prepared by a Corneal Tissue Bank under Current-Good-Tissue-Practice (CGTP) and delivered to the respective institutions for transplantation. Participants will be monitored up to 24 months post-transplantation to assess for adverse events of the randomized tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 and older
- •Willing and able to provide written informed consent
- •Willing and able to comply with study assessments for the full duration of the study
- •Patients undergoing high-risk penetrating keratoplasty, defined as corneal neovascularization (NV) in 1 or more quadrants ≥2 mm from the limbus or extension of corneal NV to the graft-host junction in a previously failed graft
- •Superficial vessels are defined as those within the anterior one-third of the cornea and deep vessels within the posterior two-thirds of the cornea (i.e., deep stroma).
- •Superficial CNV involving ≤2 quadrants (equivalent to ≤6 clock hours) without deep CNV are classified as mild. CNV with >2 quadrants of superficial vessels (>6 clock hours) or 1 quadrant of deep vessels (>3 clock hours) as severe (36).
排除标准
- •History of Stevens-Johnson syndrome or ocular pemphigoid
- •Ocular or periocular malignancy
- •Non-healing epithelial defect of at least 0.5x0.5 mm in host corneal bed lasting ≥6 weeks preoperatively
- •Uncontrolled glaucoma
- •Change in topical corticosteroid regimen within 14 days of transplantation
- •Use of systemic immunosuppressive for indication other than corneal graft rejection
- •Participation in another simultaneous medical investigation or trial
- •Pregnancy (positive pregnancy test) or lactating
- •Pre-menopausal women not using adequate contraception (Reliable intrauterine devices, hormonal contraception or a spermicide in combination with a barrier method)
- •Ocular infection within 30 days prior to study entry.
- •Presence of anterior chamber intraocular lens
- •Active uveitis within 90 days prior to the study entry.
- •No ocular surgery or procedure within 90 days prior to the study entry or concomitant to the study procedure.
研究组 & 干预措施
Participants Receiving Treated Cross Linked Corneal Tissue
Participants in this group will receive tissue that has been treated with 0.1% riboflavin (Vitamin B2) and 20% dextran (Photrexa® viscous and Photrexa®) with UV light treatment. Participants will be monitored over a period of 24 months.
干预措施: Corneal Donor Tissue with Cross Linking (Procedure)
Participants Receiving Untreated Cross Linked Corneal Tissue
Participants in this group will receive tissue that has has not been treated with 0.1% riboflavin (Vitamin B2) and 20% dextran (Photrexa® viscous and Photrexa®) without UV light treatment. Participants will be monitored over a period of 24 months.
干预措施: Corneal Donor Tissue without Cross Linking (Procedure)
结局指标
主要结局
Determining the Primary Safety of Corneal Cross Linking
时间窗: 24 Months
The occurrence of adverse events throughout study including: 1. Ocular Safety per the incidences and severity of ocular adverse events during the study based on ophthalmic examination and participants' self-report. 2. Short Term Safety Events (Post Surgery \< 1 Month) * Post-Op Microbial Keratitis * Acute Rejection (Epithelial, Endothelial, Sub epithelial, or Mixed) 3. Long Term Safety Events (Post Surgery \> 1 Month) * Rejection (Epithelial, Endothelial, or Mixed) * Graft Failure * Ulcerative Keratitis * Persistent Epithelial Defect lasting more than 6 Weeks
次要结局
- Measure of the Frequency of Graft Failures though Corneal Cross Linking(24 Months)
- Measure of Time from Surgery to Overall Graft Failure for Corneal Cross Linking over 24 Months(24 Months)
- Measure of Time from Surgery to Graft Rejection for Corneal Cross Linking over 24 Months(24 Months)
- Measure of the Efficacy of Corneal Cross Linking Through Image Review(24 Months)
- Measure of the Frequency of Graft Failures though Corneal Cross Linking(24 Months)
- Measure of Time from Surgery to Overall Graft Failure for Corneal Cross Linking over 24 Months(24 Months)
- Measure of Time from Surgery to Graft Rejection for Corneal Cross Linking over 24 Months(24 Months)
- Measure of the Efficacy of Corneal Cross Linking Through Image Review(24 Months)
研究者
Joseph B. Ciolino, MD
Associate Professor of Ophthalmology
Massachusetts Eye and Ear Infirmary