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Comparison of effect of topical ophthalmic drop tacrolimus 1% versus topical ophthalmic drop dexamethasone 1% in the treatment of patients with shield ulcer

Protocol summary

Summary
(1)objective: comparison of effect of topical ophthalmic drop tacrolimus 1% versus topical ophthalmic drop dexamethasone 1% in the treatment of patients with shield ulcer; (2)study design: Randomized, convenience sampling and dividing the patients into two groups based on the permutation blocks,double-blind for both groups of the study, controlled with medication, single-center, phase II trial; (3)study population: patients with diagnosis of shield ulcers; (4) main inclusion criteria: no history of any eye disease, eye trauma, eye surgery and lens usage, no use of concomitant other drugs, no usage of corticosteroids ten days before entering the study; (5)main exclusion criteria: simultaneous eye disease, eye trauma, surgery, smoking and steroid usage lens ten days before entering the study; (6)sample size:10 patients in each group and a total of 20; (6)interventions: administration of topical ophthalmic drop tacrolimus 1% in the first group and topical ophthalmic drop dexamethasone 1% in the second group for 3 months; (7)intervention time: at the time of diagnosis for 3 months; (8 )primary outcomes: reduced size of shield ulcer, corrected visual acuity, reepithialization.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016110630746N1
Registration date: 2016-12-25, 1395/10/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-12-25, 1395/10/05
Registrant information
Name
Nima Rastgar Rad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 0178
Email address
rrnima88@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zahedan University of Medical Sciences, Zahedan
Expected recruitment start date
2015-07-29, 1394/05/07
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of topical ophthalmic drop tacrolimus 1% versus topical ophthalmic drop dexamethasone 1% in the treatment of patients with shield ulcer
Public title
Comparison of effect of topical ophthalmic drop tacrolimus 1% versus topical ophthalmic drop dexamethasone 1% in the treatment of patients with shield ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: no history of any eye disease; eye trauma, eye surgery and lens usage; no use of concomitant other drugs; no usage of corticosteroids ten days before entering the study Exclusion criteria: simultaneous eye disease; eye trauma, surgery; smoking and steroid usage lens ten days before entering the study
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 20
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
Street address
Ethics Committee of Zahedan University of Medical Sciences, Zahedan University of Medical Sciences, Dr.Hesabi Square, Zahedan
City
Zahedan
Postal code
Approval date
2015-06-28, 1394/04/07
Ethics committee reference number
IR.zaums.rec.1394.63

Health conditions studied

1

Description of health condition studied
Keratities
ICD-10 code
H16.0
ICD-10 code description
Corneal ulcer

Primary outcomes

1

Description
Reepithialization
Timepoint
2 weeks, 1 month, 2 months, 3 months after intervention and 1 months after intervention deadline
Method of measurement
Physical examination by Ophthalmologist

2

Description
Shield ulcer's size
Timepoint
2 weeks, 1 month, 2 months, 3 months after intervention and 1 months after intervention deadline
Method of measurement
Based on physical examination by slit lamp

3

Description
Corrected visual acuity
Timepoint
2 weeks, 1 month, 2 months, 3 months after intervention and 1 months after intervention deadline
Method of measurement
Based on physical examination by snellen chart

Secondary outcomes

empty

Intervention groups

1

Description
Group 1: administration of topical ophthalmic drop tacrolimus 1% of Zahravi-Tehran company one drop every 12 houre for 3 months
Category
Treatment - Drugs

2

Description
Group 2: administration of topical ophthalmic drop dexamethasone 1% of Tehran-Daroupakhsh company one drop every 12 houre for 3 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Eye Hospital
Full name of responsible person
Nima Rastgar Rad
Street address
Al-Zahra Eye Hospital, Shahid Motahari(Airport) Blvd., Zahedan, Sistan and Baluchestan, 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
Mohsen Taheri
Street address
Vice chancellor for research, Zahedan University of Medical Sciences, Zahedan
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
Zahedan University of Medical Sciences
Full name of responsible person
Nima Rastgar Rad
Position
Ophthalmology Residence
Other areas of specialty/work
Street address
Al-Zahra Eye Hospital, Shahid Motahari(Airport) Blvd., Zahedan, Sistan and Baluchestan, Iran.
City
Zahedan
Postal code
9816737789
Phone
+98 54 3322 4991
Fax
+98 33233550
Email
rrnima88@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. MohammadNaim Amini Fard
Position
Associate Professor of Ophthalmology
Other areas of specialty/work
Street address
Al-Zahra Eye Hospital, Shahid Motahari(Airport) Blvd., Zahedan, Sistan and Baluchestan, Iran.
City
Zahedan
Postal code
9816737789
Phone
+98 54 3232 6423
Fax
Email
Naim_aminifard@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Nima Rastgar Rad
Position
Ophthalmology Residence
Other areas of specialty/work
Street address
Al-Zahra Eye Hospital, Shahid Motahari(Airport) Blvd., Zahedan, Sistan and Baluchestan, Iran.
City
Zahedan
Postal code
9816737789
Phone
+98 54 3322 4991
Fax
+98 33233550
Email
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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