Effect of Ectoine on Stromal Haze, Wound Healing and Pain After Photorefractive Keratectomy.
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Corneal Densitometry (assesed by Pentacam).
研究概览
简要总结
This is a comparative, open label, parallel group, non interventional study aims to assess the effect of Ectoine containing eye drops on stromal haze, pain and epithelial healing after Photorefractive keratectomy (PRK). The patient apply Ectohylo eye drops (Ectoine +Sodium Hyauronate) in the right eye and Polyfresh Extra eye drops (Carboxymethyl cellulose + Sodium Hyauronate ) in the left eye plus the routine post PRK treatment in both eyes. Post operative pain , epithelial healing and corneal densitometry is observed in both eyes.
详细描述
Photorefractive keratectomy (PRK) is a commonly used operation for laser vision correction. The main fears of this type of laser vision correction is corneal haze, delayed epithelial healing and postoperative severe pain. Ectoine is a natural compound that has the ability to protect biological membranes from damage and environmental effects. This study assess the use of Ectoine containing eye drops to protect the bare ocular surface and reduce inflammation after PRK that will inturn is expected to affect the post operative corneal haze, pain, and epithelial healing .
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing PRK for myopia and myopic astigmatism when astigmatism is 2.5 diopters or less and myopia with spherical equivalent -4 or less.
排除标准
- •patient spherical equivalent more myopic than -4 diopters
- •Patients with astigmatism more than 2.5 diopter
- •Patients with anisometropia ( difference > 2 diopters)
- •Patient with previous ocular surgery
- •Patients with chronic systemic disease that can affect results of laser vision correction (e.g. rheumatoid arthritis)
- •Pregnant and lactating females
结局指标
主要结局
Corneal Densitometry (assesed by Pentacam).
时间窗: 3 months post operative
Post photo refractive keratectomy early haze (3 months after operation) assesed by Pentacam densitometry
次要结局
- Time of Epithelial healing (days)(2-7 days)
- Pain score (0 -10)(2 days)
研究者
Mohamed Elkadim
Lecturer of ophthalmology
Tanta University