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A controlled trial of topical Povidone-iodine to treat EKC

Protocol summary

Summary
1. Objectives : A controlled trial of topical Povidone-iodine to treat EKC 2. Design : Randomized, Double-blind 3. Setting and conduct : Patients in the study will be randomly assigned to three groups. Povidone iodine 0.4% and Povidone iodine 0/2% eye drops is prescribed. The control group received conventional treatment prescribed for the disease, Then the results can be studied. 4. Inclusion criteria : Patients who are diagnosed EKC by an special anterior segment ophthalmolog and clinically had viral conjunctivitis symptoms (Redness, Purulent discharge, Foreign body sensation, Follicular conjunctival reaction, Pthechia) Exclusion criteria: Pregnancy, Steroid dependent glaucoma, Herpes simplex keratitis history, Symptoms for more than 3 days, Less than 7 years old, More than 50 years old , And lack of follow-up visits. 5. Intervention : Povidone iodine0.4% and Povidone iodine 0/2% eye drops 6. Main outcome measures variables : Injection, Discharge, Peri orbital edem, Chemosis, Bloody discharge, Foreign body sensation, Discharge, Tearing, Feeling care, Sub epithelial opacity in the three groups will be compared. In this study, We attempt to examine effect of topical Povidone iodine to treat epidemic keratoconjunctivitis.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015021518004N2
Registration date: 2015-06-01, 1394/03/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-06-01, 1394/03/11
Registrant information
Name
Mohammad Hossein Validad
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 1342 5715
Email address
validad@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-05-05, 1394/02/15
Expected recruitment end date
2016-05-04, 1395/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A controlled trial of topical Povidone-iodine to treat EKC
Public title
A controlled trial of topical Povidone-iodine to treat EKC
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Injection ؛ Purulent discharge ؛ Foreign body sensation ؛ Follicular conjunctival reaction ؛ Pthechia ;؛ Exclusion criteria: Pregnancy ؛ Steroid dependent glaucoma ؛ Herpes simplex keratitis history ؛ Symptoms for more than 3 days ؛ Less than 7 years old ؛ More than 50 years old ؛ And lack of follow-up visits؛ .
Age
From 6 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences, Zahedan, Iran
Street address
Pardis of Zahedan University of Medical Sciences , Hesabi av , Zahedan, Iran
City
Zahedan
Postal code
۹۸۱۶۷۴۳۴۶۳
Approval date
2015-02-22, 1393/12/03
Ethics committee reference number
1497

Health conditions studied

1

Description of health condition studied
Epidemic Keratoconjunctivitis
ICD-10 code
H16.2
ICD-10 code description
Superficial keratitis with conjunctivitis

Primary outcomes

1

Description
Injection
Timepoint
1, 4, 7, 10 day
Method of measurement
Ophthalmologist visit

2

Description
Discharge
Timepoint
1, 4, 7, 10 day
Method of measurement
Ophthalmologist visit

3

Description
Peri orbital edem
Timepoint
1, 4, 7, 10 day
Method of measurement
Ophthalmologist visit

4

Description
Chemosis
Timepoint
1, 4, 7, 10 day
Method of measurement
Ophthalmologist visit

5

Description
Bloody discharge
Timepoint
1, 4, 7, 10 day
Method of measurement
Ophthalmologist visit

6

Description
Foreign body sensation
Timepoint
1, 4, 7, 10 day
Method of measurement
Patient answer

7

Description
Discharge
Timepoint
1, 4, 7, 10 day
Method of measurement
Patient answer

8

Description
Tearing
Timepoint
1 ,4, 7, 10 day
Method of measurement
Patient answer

9

Description
Feeling cure
Timepoint
1, 4, 7, 10 day
Method of measurement
Patient answer

10

Description
Sub epithelial opacity
Timepoint
10th day
Method of measurement
Patient answer

Secondary outcomes

1

Description
none
Timepoint
none
Method of measurement
none

Intervention groups

1

Description
Group 3 : Betamethasone drop 0.1%, Chloramphenicole drop, Artificial tear, All drops every 4 hour, 4 times daily for 9 days
Category
Treatment - Drugs

2

Description
Group 1 : Povidone iodine 0.4% drop, Betamethasone 0.1% drop, Artificial tear, Povidone iodine first 3 days every 4 hour,Second 3 days every 8 hour and third 3 days every 12 hour for 9 days overally, Other drops every 4 hour, 4 times daily for 9 days
Category
Treatment - Drugs

3

Description
Group 2 : Povidone iodine 0.2% drop, Betamethasone 0.1% drop, Artificial tear, Povidone iodine first 3 days ever 4 hour,second 3 days every 8 hour and third 3 days every 12 hour for 9 days overally, Other drops every 4 hour, 4 times daily for 9 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra eye hospital, Zahedan
Full name of responsible person
Dr. Gholamreza Seyedpiran
Street address
Alzahra eye hospital , Motahari av , Zahedan, Iran
City
Zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Zahedan University of Medical Sciences
Full name of responsible person
Miss Shafaghat
Street address
Pardis of Zahedan University of Medical Sciences , Hesabi av , Zahedan, Iran
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Alzahra eye hospital, Zahedan
Full name of responsible person
Dr. Gholamreza Seyedpiran
Position
Ophthalmology resident
Other areas of specialty/work
Street address
Alzahra eye hospital , Motahari av , Zahedan , Iran
City
Zahedan
Postal code
9816737789
Phone
+98 54 3322 4991
Fax
+98 33233550
Email
rezaseyyedpiran@gmail.com
Web page address
http://eye.zaums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Alzahra eye hospital, Zahedan
Full name of responsible person
Dr. Mohammad Hossein Validad
Position
Anterior segment spechialist
Other areas of specialty/work
Street address
Alzahra eye hospital , Motahari av , Zahedan , Iran
City
Zahedan
Postal code
9816737789
Phone
+98 54 3322 4991
Fax
+98 33233550
Email
mhovalidad@yahoo.com
Web page address
http://eye.zaums.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Alzahra eye hospital
Full name of responsible person
Dr. Gholamreza Seyedpiran
Position
Ophthalmology resident
Other areas of specialty/work
Street address
Alzahra eye hospital , Motahari av , Zahedan , Iran
City
Zahedan
Postal code
9816737789
Phone
+98 54 3322 4991
Fax
+98 33233550
Email
rezaseyyedpiran@gmail.com
Web page address
eye.zaums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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