To compare the outcome of therapeutic penetrating keratoplasty for fungal keratitis with late vs immediate postoperative addition of topical corticosteroids.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Graft survival rate at 6 months in both the groups and compared.
研究概览
简要总结
Prospective candidates for the study will be required to review andunderstand the appropriate InformedConsent Form, approved by the Institutional Review Board of LVPEI.
All subjects with proven fungal keratitis who underwent TPK,suitable according the inclusion criteria will be enrolled and randomized intotwo groups as per a computer-generated list to receive either (Group A) topicalcorticosteroids with continuation of antifungals both topically and oral or continuationof only antifungals alone for 2 weeks with later addition of corticosteroids(Group B). The patients of both thegroups will be followed up regularly every 3, 7,14, 30 days, 3 , 6 months and 1year of follow-up.
At the end of the study, there will be evaluation of both the groupswere compared in terms of graft survival and recurrence of infection as primaryand secondary outcome measures.
The graft survival is clinically defined as clear and compactcorneal graft at the end of six months of follow up.
Recurrence of infection is defined as microbiologically confirmed (eitherby corneal scraping of the infiltrate or anterior chamber aspiration)recurrence of similar infection on the graft.
All patients will also receive 1% atropine sulphate ophthalmicsolution to reduce intraocular inflammation and prevent synechiae.Anti-glaucoma medication may be added if required. The atropine will beadministered to the affected eye(s) thrice a day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Cases with microbiologically confirmed fungal keratitis undergoing therapeutic keratoplasty for worsening of infection.
- •2.Size of infiltrate less or equal to 10 mm.
- •3.Intraoperative no evidence of residual infection 4.Immediate Post operative anterior chamber formed and no clinical evidence of infection 5.Use of MK medium corneal tissue of any grade with or with out intact epithelium 6.Intraoperative Preserved lens 7.Ready to give consent 8.Consent for regular follow-up 9.More than 18 years 10.Surgery performed by surgeons with experience of performing more than 20 TPK.
排除标准
- •1.Any evidence of intraop or clinical post-operative infection 2.Size of infiltrate > 10 mm 3.Not willing to come for regular follow-up or admission or giving consent 4.Disorganized anterior chamber 5.Posterior segment involvement as confirmed on Echoes in the posterior segment on B scan 6.Intraoperative presence of retero-iris and lens exudates.
- •7.Presence if corneal perforation before the surgery 8.Presence of uncontrolled diabetes or any other cause of decreased imununity.
结局指标
主要结局
Graft survival rate at 6 months in both the groups and compared.
时间窗: 3, 7,14, 30 days, 3 , 6 months and 1 year of follow-up
次要结局
- Number of patients having recurrence of similar infection with in 2 weeks of surgery.(3, 7,14, 30 days, 3 , 6 months and 1 year of follow-up)