NCT04054817已完成不适用
A Multicenter, Open-label, Single-arm Study Assess the Collagen Ophthalmic Matrix for Anterior Lamellar Keratoplasty.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- Incidence rate of irreversible graft dissociation or irreversible graft rejection within 6 months.
研究概览
简要总结
The goal of this clinical trial is to investigate the safety and clinical performance of ABCcolla Collagen Ophthalmic Matrix used for anterior lamellar keratoplasty in patients suffering from corneal ulcer.
Participants will undergo keratoplasty using the investigational product and be followed up for 24-week observation (total of 10 times).
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria:
- •Male or female from 20 to 80 years old
- •Subject who has been diagnosed with corneal ulcer
- •The depth or the size of the ulcer increases or increased anterior chamber inflammation after treatment (clinic, hospitalization, or others...)
- •The corneal ulcer affects corneal stroma depth to 1/3 and infiltrates >2 mm diameter, detected by OCT
- •Best corrected vision acuity < 0.05
- •Subject who signs the informed consent form (ICF), and agrees to complete the treatment and follow-up
排除标准
- •Accepted keratoplasty
- •Has a corneal perforation and expects to have vision
- •Has a severe dry eye
- •Experience s incomplete eyelid closure
- •H as liver function (ALT and AST) tests with the score as twofold or greater than that of the normal
- •Has renal function (Cr) levels greater than normal two folders
- •Has serum protein 10% low than normal
- •Has severe cardiovascular and cerebral vascular disease
- •Subject with uncontrolled diabetes
- •Subject with current malignancy
- •Known to be allergic to collagen
- •Has a systemic collagen connective tissue disease
- •Has a constitution prone to severe allergic reactions
- •Use s anticoagulants 5 days before studying keratoplasty
- •Use s injectable NSAID 3 days before studying keratoplasty
- •Cannot accept investigated material due to religious or cultural reason
- •Pregnant or breastfeeding women or childbearing-age women who plan to get pregnant
- •Participation in any drug or medical device clinical trial within 30 days prior to signing the informed consent form;
- •Not being considered suitable for this study by the investigator
研究组 & 干预措施
Single Arm
Experimental
干预措施: Lamellar keratoplasty-ABCcolla® Collagen Ophthalmic Matrix (Device)
结局指标
主要结局
Incidence rate of irreversible graft dissociation or irreversible graft rejection within 6 months.
时间窗: After the surgery, patients will be examined for follow-up observation for 24 weeks.
Count the number of subjects with irreversible graft dissolution or irreversible rejection within 24 weeks, and calculate the incidence rate
次要结局
- The extent of graft vascularization(24-week follow-up visit. Totoa 9 times.)
- The extend of corneal edema(24-week follow-up visit. Totoa 9 times.)
- Best corrected vision acuity(24-week follow-up visit. Totoa 9 times.)
- The extent of graft transparency(24-week follow-up visit. Totoa 9 times.)
- Infection recurrence(24-week follow-up visit. Totoa 9 times.)
- Light sensitivity(24-week follow-up visit. Totoa 9 times.)
研究者
研究点 (3)
Loading locations...
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