To study the impact of oral administration of lactoferrin in post refractive surgery dry eye.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Prevalence of post refractive surgery dry eye comes to 10% from 35% at 6 month post surgery
研究概览
简要总结
This study aims to evaluate the dry eye induced by refractive surgery and the effect of oral lactoferrin on the post refractive surgery dry eye. Refractive surgeries are known to induce postoperative dry eye, furthermore, the inflammation caused by the surgery, the distortion of the ocular surface and preservative in the eye drops used post-operatively, all exacerbate the condition. Lactoferrin, a glycoprotein present in the tears, has several functions, including anti-inflammatory, antimicrobial and as well as promotion of cell growth. Lactoferrin treatment for the post refractive surgery dry eye proves to be significant by this study and we will be able to develop a feasible and reliable nutritional supplement for dry eye.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients undergoing refractive surgery.
- •2.Willingness to sign written informed consent and follow up.
排除标准
- •1.Patients with a history of ocular surgery other than refractive surgery.
- •2.Pregnancy and feeding mothers.
- •3.Lactose intolerance or cow milk allergy.
- •4.Patients not willing for participate and follow ups.
结局指标
主要结局
Prevalence of post refractive surgery dry eye comes to 10% from 35% at 6 month post surgery
时间窗: Dry eye work up will be done at baseline, before refractive surgery then 1 week, 1 month, 3 month and 6 month post surgery
次要结局
- Bioavailability of lactoferrin in tear film(Tear samples will be collected at baseline, before surgery then 1 month, 3 month and 6 month post refractive surgery)
研究者
Chetan
Dr R P Centre for Ophthalmic sciences, AIIMS, New Delhi.