Povidone Iodine 5% Eye Wash in Treatment of Epidemic Keratoconjunctivitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 350
- 主要终点
- Ocular symptoms of epidemic keratoconjunctivitis
研究概览
简要总结
Background: Epidemic Keratoconjunctivitis (EKC) is a form of adenoviral conjunctivitis. It is highly infectious disease mainly affect the outer eye surface and has a frequency to happen in epidemics especially in closed communities such as hospitals, schools and factories.
purpose: The purpose of this study to compare between the modified and the ordinary method of treatment for EKC.
Patients and methods: Three hundred fifty patients of EKC were enrolled in the study. The diagnosis was made by clinical picture and laboratory investigations. Group 1 had two hundred patients 120 males, 80 females (age from 18 to 60 years) were treated by the modified method and group 2 had one hundred fifty patients 100 males,50 females (age from 18 to 58 years) were treated with the ordinary method. The study was hold between November 2014 to October 2018 in Security forces Hospital, Riyadh, Saudi Arabia. Patients were followed up for 3 months up to 2 years. The main outcome were improvement in clinical picture and recovery.
详细描述
Patients and Methods Three hundred fifty patients suffered from EKC were enrolled in the study. Their diagnosis was made by clinical picture and laboratory investigations. Group 1 had two hundred patients 120 males, 80 females (age from 18 to 60 years) were treated by the modified method and group 2 had one hundred fifty patients 100 males,50 females (age from 18 to 58 years) were treated with the ordinary method. The study was done between November 2014 to October 2018 in Security forces Hospital, Riyadh, Saudi Arabia. Patients were followed up for 3 months up to 2 years. The main outcomes were improvement in patients clinical picture and recovery. All patients signed a consent for inclusion in the study and the study was approved by the ethical committee and it was in agreement with declaration of Helsinki tents.
All cases were diagnosed by clinical symptoms and signs as shown in table (2& 3) and conjunctival smear for some suspected patients which revealed lymphocytes predominance. Slit lamp examination and visual acuity measurement were done and grading of ocular symptoms and signs were estimated according to severerity into normal, mild, moderate or severe. The patients were divided into group 1 in which patients were treated by the modified method (Povidone Iodine 5% eye wash irrigation) and group 2 in which patients were treated by the ordinary method.
Modified method The eye was topically anesthetized, then eye wash with Povidone Iodine 5% (povidone-iodine, Alcon) eye irrigation every day until the patients recovered. Manual removal of pseudo membranes with non toothed forceps and cotton tipped applicator on slit lamp. Antibiotic eye drops (moxifloxacin 0.5%) QID. Lubricant eye drops (tears natural free minims eye drops) QID. Cold compresses. Topical corticosteroid eye drops (fluorometholone 0.1%) QID in cases of subepithelial infiltrates or pseudomemrane formation.
Usual method The same way of management except the eye wash with Povidone Iodine 5% . Steroids was used for symptomatic relief but it do not lower the disease pathway. It suppress the corneal inflammation, improve overall comfort but they also prolong clearance of the virus and the lesions may recur if steroid is prematurely discontinued.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Including adult patients with 18 to 60 years old
- •Patients with BCDVA of ≥ 20/80 in the study eye
- •If the patent have bilateral EKC only one eye included in the study
- •Patients attending all the required follow up visits as advised.
排除标准
- •Patients with ocular infection rather than EKC
- •Patients with corneal ulceration or bacterial keratitis
- •Immunocompromised patients
- •Patients not attending the required follow up visits.
研究组 & 干预措施
Modified method
Povidone Iodine
干预措施: Povidone-Iodine (Drug)
Ordinary method
normal saline
干预措施: Normal Saline Flush (Drug)
结局指标
主要结局
Ocular symptoms of epidemic keratoconjunctivitis
时间窗: 2 weeks
Ocular symptoms of epidemic keratoconjunctivitis include the following 1-Lid swelling. 2-Red eyes. 3- Watery discharge. 4- Photophobia. 5- Eye discomfort . Each symptom evaluated with grade severity:- Normal= no abnormality (0 score), mild= subtle abnormality (1-2 score), moderate= obvious abnormality (3-4 score) and severe = marked abnormality (5 score). the minimum value was 0 score and means better outcome and maximum score is 5 and means worse outcome.
Ocular signs of epidemic keratoconjunctivitis
时间窗: 2 weeks
Ocular signs of epidemic keratoconjunctivitis include the following 1- Lid edema. 2- Follicular conjunctivitis. 3-Pseudomembrane formation. 4- Punctate epithelial keratitis. Each sign evaluated with grade severity:- Normal= no abnormality (0 score), mild= subtle abnormality (1-2 score), moderate= obvious abnormality (3-4 score) and severe = marked abnormality (5 score). the minimum value was 0 score and means better outcome and maximum score is 5 and means worse outcome.
次要结局
未报告次要终点
研究者
Shaaban Elwan
Assistant professor of ophthalmology
Minia University