Steroids and Cross-linking for Ulcer Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 280
- 试验地点
- 3
- 主要终点
- Best Spectacle-Corrected Visual Acuity
研究概览
简要总结
Steroids and Cross-linking for Ulcer Treatment (SCUT II) is an international, randomized, double-masked, clinical trial. The purpose of this study is to determine differences in 6-month visual acuity between medical antimicrobial treatments alone versus antimicrobial treatment plus collagen cross-linking (CXL), as well as to further evaluate findings from subgroup analyses of SCUT. Patients presenting to the Aravind Eye Care System (India), Kaiser Permanente Northern California (USA), or the University of California, San Francisco (USA) with smear-positive and/or culture-positive typical (i.e. non-Nocardia or Mycobacteria) bacterial corneal ulcers and moderate to severe vision loss, defined as Snellen visual acuity of 20/40 or worse, will be eligible for inclusion. Those who agree to participate will be randomized to one of three treatment groups:
Group 1: Standard therapy, topical 0.5% moxifloxacin plus topical placebo plus sham CXL Group 2: Early steroids, topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus sham CXL Group 3: CXL plus early steroids, topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus CXL
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Corneal ulcer that is smear positive and/or culture positive (within 24 hours) for typical bacteria (i.e. non-Nocardia or Mycobacteria)
- •Moderate to severe vision loss, defined as Snellen visual acuity of 20/40 (6/12) or worse
- •Corneal thickness ≥350 µm, as measured on AS-OCT
- •Age over 18 years
- •Basic understanding of the study as determined by the physician
- •Commitment to return for follow up visits
排除标准
- •Evidence of concomitant infection on exam, gram stain, or confocal microscopy (i.e. herpes, both bacteria and acanthameoba on gram stain)
- •Impending or frank perforation at recruitment
- •Involvement of sclera at presentation
- •Non-infectious or autoimmune keratitis
- •History of corneal transplantation or recent intraocular surgery
- •Pinhole visual acuity worse than 20/200 in the unaffected eye
- •Participants who are decisionally and/or cognitively impaired
研究组 & 干预措施
Cross-Linking plus Early Steroids
Participants in this group will receive topical 0.5% moxifloxacin plus topical steroids plus corneal cross-linking.
干预措施: Difluprednate Ophthalmic (Drug)
Standard Therapy
Participants in this arm will receive topical 0.5% moxifloxacin plus topical placebo plus sham corneal cross-linking.
干预措施: Moxifloxacin Ophthalmic (Drug)
Standard Therapy
Participants in this arm will receive topical 0.5% moxifloxacin plus topical placebo plus sham corneal cross-linking.
干预措施: Riboflavin Ophthalmic (Drug)
Standard Therapy
Participants in this arm will receive topical 0.5% moxifloxacin plus topical placebo plus sham corneal cross-linking.
干预措施: Topical Placebo (Other)
Early Steroids
Participants in this arm will receive topical 0.5% moxifloxacin plus topical steroids plus sham corneal cross-linking.
干预措施: Moxifloxacin Ophthalmic (Drug)
Early Steroids
Participants in this arm will receive topical 0.5% moxifloxacin plus topical steroids plus sham corneal cross-linking.
干预措施: Difluprednate Ophthalmic (Drug)
Cross-Linking plus Early Steroids
Participants in this group will receive topical 0.5% moxifloxacin plus topical steroids plus corneal cross-linking.
干预措施: Moxifloxacin Ophthalmic (Drug)
Cross-Linking plus Early Steroids
Participants in this group will receive topical 0.5% moxifloxacin plus topical steroids plus corneal cross-linking.
干预措施: Riboflavin Ophthalmic (Drug)
结局指标
主要结局
Best Spectacle-Corrected Visual Acuity
时间窗: 6 Months
Best Spectacle-Corrected Visual Acuity
次要结局
- Best Spectacle-Corrected Visual Acuity(3 Weeks, 3 Months, 12 Months)
- Number of Ulcers Testing Positive for Bacteria on Repeat Culture(2 Days)
- Scar Size(3 Weeks, 3 Months, 6 Months 12 Months)
- Scar Depth(3 Weeks, 3 Months, 6 Months, 12 Months)
- Adverse Events(12 Months)
研究者
Thomas M. Lietman
Professor
University of California, San Francisco