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Evaluation of topical tacrolimus eye drop 0.05% in treatment of non-necrotizing HSV stromal keratitis.

Protocol summary

Summary
Object: Evaluation of topical tacrolimus eye drop 0.05% in treatment of non-necrotizing herpetic stromal keratitis and decrease It’s sequels. Inclusion criteria: Cases with non-necrotizing herpetic stromal keratitis that are in active phase of disease. Exclusion criteria:Cases with necrotizing stromal keratitis, History of corneal graft ,History of intraocular operation, Trauma,Pregnant and breast feeding women. Intervention: consecutive patients who affected with active phases of non-necrotizing herpetic stromal keratitis that referred to emergency room and ophthalmology clinic devide in 2 equal groups (each group 25 case) randomly. In this study, one group of the patients will underwent conventional treatment for HSK ( include oral acyclovir and topical steroid) and in another group, topical tacrolimus eye drop 0/05% four times a day will add to conventional treatment. Before any treatment and after 3 days, one week, two weeks , three weeks and four weeks after treatment the patients underwent full ocular examination including: Best corrected visual acuity, intra ocular pressure measurement , Complete slit lamp examination for grading corneal opacity ,corneal edema and vascularization and corneal sensation measurement will perform. Primary outcome measure: change in corneal opacity and edema after treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016102429871N2
Registration date: 2016-11-17, 1395/08/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-11-17, 1395/08/27
Registrant information
Name
Mita Akbari
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3323 6886
Email address
mitra.akbari@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical sciences, Pro- Vice- Chanceller for research
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of topical tacrolimus eye drop 0.05% in treatment of non-necrotizing HSV stromal keratitis.
Public title
The effect of tacrolimus eye drop in treatment of herpetic corneal ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Cases with non-necrotizing herpetic stromal keratitis that are in active phase of disease. Exclusion criteria: Cases with necrotizing stromal keratitis or history of corneal graft, History of intraocular operation and trauma, Pregnant and breast feeding women will exclude for this study.
Age
From 10 years old to 90 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Amiralmomenin Hospital
Street address
17 Shahrivar Street
City
rasht
Postal code
Approval date
2016-10-15, 1395/07/24
Ethics committee reference number
IR.GUMS.REC.1395.219

Health conditions studied

1

Description of health condition studied
herpetic non-necrotizing stormal keratitis
ICD-10 code
H19.1
ICD-10 code description
Herpesviral keratitis and keratoconjunctivitis

Primary outcomes

1

Description
change in corneal opacity and edema
Timepoint
3 days, one week, two weeks, three weeks and four weeks after treatment
Method of measurement
clinical exam and scoring

Secondary outcomes

1

Description
change in corneal vascularization
Timepoint
3days,one week,two weeks,three weeks and four weeks after treatment
Method of measurement
clinical exam and scoring

Intervention groups

1

Description
Conventional treatment for Non- necrotizing herpetic stromal keratitis including (oral acyclovir 400 mg 5 times a day for 10 days and topical prednisolone acetate 1% eye drop every 2 hours with tapering regarding to inflammatory response).
Category
Treatment - Drugs

2

Description
In another group,beside conventional treatment with oral acyclovir(400mg, 5 times a day for 10 days) and topical prednisolone acetate 1% eye drop every 2 hours with tapering, topical tacrolimus eye drop 0/05% four times a day for one month will prescribe.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Dr Mitra Akbari
Street address
17 Shahrivar Street
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Guilan University of Medical Sciences, Pro-Vice -Chancellor for research
Full name of responsible person
Mrs Susan Komaie
Street address
17 Shahrivar Street
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Sciences, Pro-Vice -Chancellor for research
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
Guilan University of Medical Sciences
Full name of responsible person
Dr Mitra Akbari
Position
Assistant Professor
Other areas of specialty/work
Street address
17 Shahrivar Street
City
Rasht
Postal code
Phone
+98 13 3323 6886
Fax
Email
mitra.akbari@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Mita Akbari
Position
Assistant Professor
Other areas of specialty/work
Street address
17 Shahrivar Street
City
rasht
Postal code
Phone
+98 13 3323 6886
Fax
Email
mitra.akbari20@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Shila Kianmehr
Position
MSc
Other areas of specialty/work
Street address
17 Shahrivar Street
City
Rasht
Postal code
Phone
+98 13 3323 6886
Fax
Email
shila.kianmehr@gmail.com
Web page address

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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