Modified Treatment for Epidemic Keratoconjunctivitis (EKC) (EKC)
Primary Purpose
Symptoms and Signs
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Povidone-Iodine
Normal Saline Flush
Sponsored by
About this trial
This is an interventional treatment trial for Symptoms and Signs
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Modified method
Ordinary method
Arm Description
Povidone Iodine
normal saline
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04169919
Brief Title
Modified Treatment for Epidemic Keratoconjunctivitis (EKC)
Acronym
EKC
Official Title
Povidone Iodine 5% Eye Wash in Treatment of Epidemic Keratoconjunctivitis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptoms and Signs
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group 1 modified method Group 2 ordinary method
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Modified method
Arm Type
Active Comparator
Arm Description
Povidone Iodine
Arm Title
Ordinary method
Arm Type
Active Comparator
Arm Description
normal saline
Intervention Type
Drug
Intervention Name(s)
Povidone-Iodine
Other Intervention Name(s)
Group1
Intervention Description
Povidone-Iodine 5% eye wash
Intervention Type
Drug
Intervention Name(s)
Normal Saline Flush
Other Intervention Name(s)
Group 2
Intervention Description
Normal Saline eye wash
Primary Outcome Measure Information:
Title
Ocular symptoms of epidemic keratoconjunctivitis
Description
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.
Time Frame
2 weeks
Title
Ocular signs of epidemic keratoconjunctivitis
Description
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.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaaban A Elwan, MD
Organizational Affiliation
Minia University and SFH
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
methods
IPD Sharing Time Frame
2 years
IPD Sharing Access Criteria
Methods and results
Citations:
PubMed Identifier
21916618
Citation
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.
Results Reference
background
Learn more about this trial
Modified Treatment for Epidemic Keratoconjunctivitis (EKC)
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