Modified Treatment for Epidemic Keratoconjunctivitis (EKC)

NCT04169919 | Completed DMC

• 1 other identifier: Security Forces Hospital, EKC
• Study Type: interventional
• Target: 350
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Symptoms and Signs

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Modified method

ACTIVE COMPARATOR

Povidone Iodine

Drug: Povidone-Iodine

Ordinary method

ACTIVE COMPARATOR

normal saline

Drug: Normal Saline Flush

Interventions

Povidone-Iodine DRUG

Povidone-Iodine 5% eye wash

Also known as: Group1

Modified method

Normal Saline Flush DRUG

Normal Saline eye wash

Also known as: Group 2

Ordinary method

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Related Publications (1)

• 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.

  PMID: 21916618 BACKGROUND

MeSH Terms

Conditions

Signs and Symptoms

Interventions

Povidone-Iodine

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Shaaban A Elwan, MD

  Minia University and SFH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of ophthalmology

Model Details: Group 1 modified method Group 2 ordinary method

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 20, 2019
• Study Start: November 1, 2014
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: November 20, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 2 years
• Access Criteria: Methods and results