Modified Treatment for Epidemic Keratoconjunctivitis (EKC) (EKC)

Povidone Iodine 5% Eye Wash in Treatment of Epidemic Keratoconjunctivitis

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.

Study Overview

• Status: Completed
• Conditions: Symptoms and Signs
• Intervention / Treatment: Drug: Povidone-Iodine; Drug: Normal Saline Flush

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.

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Modified method; Povidone Iodine	Drug: Povidone-Iodine; Povidone-Iodine 5% eye wash; Other Names: Group1
ACTIVE_COMPARATOR: Ordinary method; normal saline	Drug: Normal Saline Flush; Normal Saline eye wash; Other Names: Group 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular symptoms of epidemic keratoconjunctivitis	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.	2 weeks
Ocular signs of epidemic keratoconjunctivitis	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.	2 weeks

Collaborators and Investigators

• Sponsor: Minia University
• Investigators: Principal Investigator: Shaaban A Elwan, MD, Minia University and SFH

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2014
• Primary Completion (ACTUAL): October 1, 2018
• Study Completion (ACTUAL): October 1, 2018

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (ACTUAL): November 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 20, 2019
• Last Update Submitted That Met QC Criteria: November 18, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Keratoconjunctivitis; Anti-Infective Agents, Local; Anti-Infective Agents; Plasma Substitutes; Blood Substitutes; Povidone-Iodine; Povidone
• Other Study ID Numbers: Security Forces Hospital, EKC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: methods
• IPD Sharing Time Frame: 2 years
• IPD Sharing Access Criteria: Methods and results
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No