Modified Treatment for Epidemic Keratoconjunctivitis (EKC)

Sponsor
Minia University (Other)
Overall Status
Completed
CT.gov ID
NCT04169919
Collaborator
(none)
350
2
47

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
350 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Group 1 modified method Group 2 ordinary methodGroup 1 modified method Group 2 ordinary method
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Povidone Iodine 5% Eye Wash in Treatment of Epidemic Keratoconjunctivitis
Actual Study Start Date :
Nov 1, 2014
Actual Primary Completion Date :
Oct 1, 2018
Actual Study Completion Date :
Oct 1, 2018

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Ocular symptoms of epidemic keratoconjunctivitis [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.

    2. Ocular signs of epidemic keratoconjunctivitis [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Minia University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Shaaban Elwan, Assistant professor of ophthalmology, Minia University
    ClinicalTrials.gov Identifier:
    NCT04169919
    Other Study ID Numbers:
    • Security Forces Hospital, EKC
    First Posted:
    Nov 20, 2019
    Last Update Posted:
    Nov 20, 2019
    Last Verified:
    Nov 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 20, 2019