Clinical trial NCT04169919: Modified Treatment for Epidemic Keratoconjunctivitis (EKC)
Official title: Povidone Iodine 5% Eye Wash in Treatment of Epidemic Keratoconjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Symptoms and Signs
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1 modified method Group 2 ordinary method
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Children
* Patients with ocular infection rather than EKC
* Patients with corneal ulceration or bacterial keratitis
* Immunocompromised patients
* Glaucoma
* Patients not attending the required follow up visits.

Primary outcomes:
measure: Ocular symptoms of epidemic keratoconjunctivitis
timeFrame: 2 weeks
measure: Ocular signs of epidemic keratoconjunctivitis
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Minia University and SFH
name: Shaaban A Elwan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trinavarat A, Atchaneeyasakul LO. Treatment of epidemic keratoconjunctivitis with 2% povidone-iodine: a pilot study. J Ocul Pharmacol Ther. 2012 Feb;28(1):53-8. doi: 10.1089/jop.2011.0082. Epub 2011 Sep 14.