Modified Treatment for Epidemic Keratoconjunctivitis (EKC)

NCT ID: NCT04169919

Last Updated: 2019-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2018-10-31

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.

Conditions

Symptoms and Signs

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Modified method

Povidone Iodine

Group Type: ACTIVE_COMPARATOR

Povidone-Iodine

Intervention Type: DRUG

Povidone-Iodine 5% eye wash

Ordinary method

normal saline

Group Type: ACTIVE_COMPARATOR

Normal Saline Flush

Intervention Type: DRUG

Normal Saline eye wash

Interventions

Povidone-Iodine

Povidone-Iodine 5% eye wash

Intervention Type: DRUG

Normal Saline Flush

Normal Saline eye wash

Intervention Type: DRUG

Other Intervention Names

Group1; Group 2

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Shaaban Elwan

Assistant professor of ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shaaban A Elwan, MD

Role: PRINCIPAL_INVESTIGATOR

Minia University and SFH

References

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.

Reference Type: BACKGROUND

PMID: 21916618 (View on PubMed)

Other Identifiers

Security Forces Hospital, EKC

Identifier Type: -

Identifier Source: org_study_id