The Use of Riboflavin/Ultraviolet A Cross-linked Human Donor Corneas as Carriers for the Boston Keratoprosthesis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Changes in Corneal Thickness at 1 Millimeter
研究概览
简要总结
The purpose of the pilot study is to test the efficacy and safety of riboflavin/Ultraviolet A (UVA) cross-linked human donor corneas as carriers for the Boston Keratoprosthesis (Boston KPro) in patients with higher risk for corneal melting (keratolysis).
详细描述
The corneal cross-linking technique has been shown to strengthen the cornea and resist degradation by the body's own enzymes. The use of highly-resistant donor corneas is meant to eliminate the serious post-operative complication of corneal melting (keratolysis) that repeatedly occurs in Boston KPro patients with severe ocular burns, autoimmune and cicatrizing diseases.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- •Age > 18 years.
- •A negative urine pregnancy test.
- •Candidate for a Boston Keratoprosthesis/Corneal transplant.
- •Generally good stable overall health.
- •Patients with an eye at risk for a cornea sterile ulcer which includes:
- •Chemical injuries.
- •Autoimmune diseases (ocular cicatricial pemphigoid, Stevens Johnson Syndrome, systemic lupus erythematosus, rheumatoid arthritis, or other autoimmune diseases).
- •History of previous sterile corneal ulceration requiring a cornea transplant.
排除标准
- •Age < 18 years.
- •Inability to provide written informed consent and comply with study assessments for the full duration of the study.
- •Pregnant or lactating women.
- •No or minimal tear production.
- •Ocular or periocular malignancy.
- •Inability to wear a contact lens due to lid abnormalities or shortened fornix.
- •Signs of current infection, including fever and current treatment with antibiotics.
- •Participation in another simultaneous medical investigation or trial
研究组 & 干预措施
Riboflavin Cross-linked donor cornea
the donor cornea used as a carrier for the Boston Keratoprosthesis will undergo crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.
干预措施: Riboflavin (Drug)
结局指标
主要结局
Changes in Corneal Thickness at 1 Millimeter
时间窗: measured at week 4, 6, 26, 32, 52
The average carrier graft thickness over the first year of postoperative follow-up. The corneal thickness was measured at each visit using AS-OCT imaging 1 mm away from the KPro stem at 3, 6, 9, and 12 o'clock. The individual corneal thickness measurements (3, 6, 9, and 12 o'clock) where then averaged. The average corneal thickness measurements for week 4, 6, 26, 32 and 52 are reported below.
Changes in Corneal Thickness at 2 Millimeter
时间窗: measured at week 4, 6, 26, 32, 52
The average carrier graft thickness over the first year of postoperative follow-up. The corneal thickness was measured at each visit using AS-OCT imaging 2 mm away from the KPro stem at 3, 6, 9, and 12 o'clock. The individual corneal thickness measurements (3, 6, 9, and 12 o'clock) where then averaged. The average corneal thickness measurements for week 4, 6, 26, 32 and 52 are reported below.
次要结局
- Number of Occurrences of Vitritis (Sterile or Infectious) Ulcers(post op week 52)
- Ocular Safety(measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52)
- Systemic Safety(measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52)
研究者
Joseph B. Ciolino, MD
Principal Investigator
Massachusetts Eye and Ear Infirmary