Role of Adjuvant Autologous Serum in Fungal Corneal Ulcer Healing: A Randomized Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
AIMS & OBJECTIVES
To study the role of autologous serum in fungal corneal ulcers in addition to standard of care
INCLUSION CRITERIA
KOH stain positive Fungal corneal ulcers with mild to moderate grade in severity patients will be included in the study .
Mild corneal ulcer includes ulcers with less than 2 mm in size, less than 20 percent depth of infiltrate
Moderate corneal ulcer include ulcers with 2to5 mm in size, 20 to 50 percent depth of infiltrate
EXCLUSION CRITERIA include Bacterial and mixed corneal ulcers, Ulcers warranting immediate surgical intervention (impending perforation or perforated ulcer), Endophthalmitis, Known allergy to study medications ,Previous keratoplasty in involved eye Unwilling or unable to participate or follow up,Pregnant or breast-feeding females, Clinical evidence of herpetic keratitis, Age less than 16 years and Hepatitis B, C, HIV and Syphilis patients
INTERVENTION AND TREATMENT
Total 40 patients who fulfilled the eligibility criteria will be randomly assigned in two groups with 20 patients in each group
Group A will receiveStandard antifungal therapy. Group B will receiveStandard antifungal therapy with 50 percent Autologous serum eye drops in the dose of one drop 6 times a day.
OUTCOME MEASURES
Primary outcome
Time to re-epithelisation
Secondary outcomes includeBest spectacle-corrected visual acuity at 3 months, Infiltrate size or scar size,,Ulcer depth, Time to ulcer healing.
No of eyes requiring surgical procedures like cyanoacrylate glue adhesive or therapeutic penetrating keratoplasty or Amniotic Membrane Transplant.
FOLLOW-UP
Patients will be assessed at baseline, day 3, 7, 14, 21, 30,60 and 90.
Outcome will be assessed at 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 16.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •KOH stain positive corneal ulcers,Mild to moderate in severity will be included in the study.
排除标准
- •Bacterial and mixed corneal ulcers,Ulcers warranting immediate surgical intervention (impending perforation/ perforated ulcer)Endophthalmitis,Known allergy to study medications ,Previous keratoplasty in involved eye Unwilling or unable to participate or follow up,Pregnant or breast-feeding females,Clinical evidence of herpetic keratitis,Age less than 16 years,Hepatitis B, C, HIV and Syphilis patients will be excluded from the study.
研究者
Dr Indu Bala
Advanced Eye Centre, Department Of Ophthalmology, PGIMER, Chandigarh