Immunosuppression During Penetrating Keratoplasty, Using a Subconjunctival Implant Releasing Dexamethasone: Tolerance and Safety Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- intraocular pressure
研究概览
简要总结
Immune rejection episodes after penetrating keratoplasty occur in 30% of patients and constitute one of the main factors reducing graft survival. They mainly occur during the first 18 months. Prevention usually relies on a topical treatment with dexamethasone or prednisolone for standard risk patients. Eye drops are instilled three times a day during at least 3 months then tapered.
OZURDEX is an absorbable small implant that releases a total of 700 micrograms dexamethasone during several months. It is indicated for intravitreal injection to treat macular edema.
The investigators hypothesized that this implant could be used after subconjunctival injection during corneal graft, to prevent immune rejection and avoid repeated eyedrop instillations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Keratoconus
- •Fuch's dystrophy
- •Hereditary stromal dystrophy
- •Age 18 years old and more
- •Signed informed consent
- •Affiliated to the French Social Security
排除标准
- •Hypersensitivity to Dexamethasone or the excipients (polylactic and glycolic acid)
- •Active ocular or periocular infection
- •Advanced glaucoma
- •History of herpetic or zoster keratitis
- •Retinal disease for which an intravitreal injection of Ozurdex is planed for the next 3-4 months
研究组 & 干预措施
ozurdex group
Subconjunctival injection of the absorbable implant of Dexamethasone immediately at the end of penetrating keratoplasty. The injection is made at the 12 O'Clock position is a bubble created by subconjunctival injection of balanced salt solution.
干预措施: Dexamethasone implant OZURDEX (Drug)
结局指标
主要结局
intraocular pressure
时间窗: one month post graft
次要结局
- Graft thickness(one month post graft)
- Patient requiring dexamethasone eyedrops(one month post graft)
- Score of ocular discomfort(Day 1, Day 2, Day 3, Day 4, Day 5, Day 15, Month 1, Week 5, Week 6, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12)
- Ocular redness(Day 1, Day 2, Day 3, Day 4, Day 5, Day 15, Month 1, Week 5, Week 6, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12)
- Rejection episodes(Day 1, Day 2, Day 3, Day 4, Day 5, Day 15, Month 1, Week 5, Week 6, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12)
- Date of disappearance of the implant(up to 1 year)
- presence of hemorrhage(Day 1, Day 2, Day 3, Day 4, Day 5, Day 15, Month 1, Week 5, Week 6, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12)
- intraocular pressure(Day 1, Day 2, Day 3, Day 4, Day 5, Day 15, Week 5, Week 6, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12)