Modified Treatment for Epidemic Keratoconjunctivitis (EKC)

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.

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Key information

Conditions

Symptoms and Signs Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Povidone-Iodine

Drug

Povidone-Iodine 5% eye wash

Other names: Group1

Normal Saline Flush

Drug

Normal Saline eye wash

Other names: Group 2

Primary outcomes

Ocular symptoms of epidemic keratoconjunctivitis

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Povidone Iodine 5% Eye Wash in Treatment of Epidemic Keratoconjunctivitis

Acronym: EKC

Important dates

Study start: 2014
Primary completion: 2018
Study completion: 2018
First posted: Nov 20, 2019
Registry last updated: Nov 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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