Perilesional injections versus topical interferon alpha 2b in ocular surface squamous neoplasia
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Outcome of treatment response clinically (Measured using slit lamp photography)
研究概览
简要总结
This is a prospective randomised comparative interventional study comparing perilesional injection vs eye drops interferon alpha 2b.
In perilesional injections,Interferon alpha 2b 3million IU/ml is given directly using tuberculin syringe and 30G needle through adjacent normal conjunctiva into subconjunctival space to achieve subconjunctival ballooning all around tumour.
In eye drops,Interferon alpha 2b 3million IU/0.5ml is mixed with 2.5ml carboxymethylcellulose to form 1million IU/ml and patient will be told to put QID continuously.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •All clinically and cytologically diagnosed OSSN Patient willing to participate and follow up.
排除标准
- •Patient already on topical or perilesional immunotherapy/chemotherapy /radiotherapy Patient having any comorbidity Intraocular or orbital OSSN (AJCC stage T3 OR T4).
结局指标
主要结局
Outcome of treatment response clinically (Measured using slit lamp photography)
时间窗: 1 month,2 month,3 month,4 month
Severity of side effects(flu like syndrome, hyperemia/follicular conjunctivitis) by each treatment modality
时间窗: 1 month,2 month,3 month,4 month
Duration of recurrences if any
时间窗: 1 month,2 month,3 month,4 month
次要结局
- To analyse changes in ocular surface using (OSA) ocular surface analyser (Tear osmolarity/ Lipid layer thickness/Tear meniscus/Non invasive breakup time/ Meibography/Ocular redness classification)(1 month,2 month,3 month,4 month)
研究者
Dr Nandini Gupta
All India Institute Of Medical Science