Comparing the effect of tacrolimus 0.03% drop and artificial tear drop on the amount of tear production in patients with dry eye after cataract surgery with phacoemulsification method.
Purpose of study: Comparing the effect of tacrolimus 0.03% drop and artificial tear drop on dry eye after cataract surgery.
Design of study: Randomized double blind clinical trial.
Method: The study will perform on patients referring to Shahid Sadoughi Hospital in Yazd. Main Inclusion criteria include patients aged above 50 years old with cataract planned for phacoemulsification. Main Exclusion criteria include diagnosis of dry eye syndrome by Schirmer 1 test <10 mm or tear film break up time <10 seconds; any history of inflammatory or infectious ocular disease; history of any prior ocular surgery; and history of any medication or condition which may induce dry eye. The patients will undergo cataract surgery. 1 week after surgery, Schirmer 1 test, tear breakup time, and Ocular Surface Disease Index would be evaluated for diagnosing new onset dry eye. 60 eyes with diagnosis of dry eye after cataract surgery, depend on the randomized code for each patient taken by the clinic staff, would undergo treatment with tacrolimus 0.03% drop every 12 hours or artificial tear drop every 6 hours. After 1 month, Schirmer 1 test, tear breakup time, and Ocular Surface Disease Index would be evaluated again by another examiner who does not know the results and groups. Then the results would be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016102430485N1
Registration date:2017-03-27, 1396/01/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-27, 1396/01/07
Registrant information
Name
Armin Hemati
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3822 4002
Email address
m.mahdavi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Yazd University of Medical Sciences
Expected recruitment start date
2016-10-29, 1395/08/08
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of tacrolimus 0.03% drop and artificial tear drop on the amount of tear production in patients with dry eye after cataract surgery with phacoemulsification method.
Public title
Impact of tacrolimus 0.03% eye drop on dry eye symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients aged above 50 years old with cataract planned for phacoemulsification.
Exclusion criteria: history of an ocular trauma or any chemical or thermal burn; allergy to any of the study medications; history of any condition that may cause dry eye; systemic connective tissue disease; corneal contact lens wear; any active ocular disease; uncontrolled systemic disease; a history of ocular allergic disease; prior refractive surgery or any ocular surgery; history of any medication which may induce dry eye; any history of inflammatory or infectious ocular disease; diagnosis of dry eye syndrome by Schirmer 1 test <10 mm or tear film break up time <10 seconds.
Age
From 50 years old
Gender
Both
Phase
N/A
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
With the SAS software, a number for each patient was reserved with a randomization code that was corresponding with that number.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yazd University of Medical Sciences
Street address
Yazd University of Medical Sciences, boulevard of Daneshgah, Yazd
City
Yazd
Postal code
8915173143
Approval date
2016-01-06, 1394/10/16
Ethics committee reference number
IR.SSU.MEDICINE.REC.1394.370
Health conditions studied
1
Description of health condition studied
dry eye syndrome
ICD-10 code
H04.1
ICD-10 code description
Other disorders of lacrimal gland
Primary outcomes
1
Description
Eye problems in doing daily jobs
Timepoint
Before intervention and one month after treatment
Method of measurement
Ocular Surface Disease Index questionnaire
2
Description
Tear break up time
Timepoint
Before intervention and one month after treatment
Method of measurement
In seconds, With timer and Slit Lamp
3
Description
Tear production
Timepoint
Before intervention and one month after treatment
Method of measurement
Schirmer 1 test in millimeters
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first patient with a unique code (1) would be given package A (include tacrolimus 0.03% drop). Patients would instil tacrolimus 0.03% drop every 12 hours a day for one month. Patients would continue this treatment for one month and return for examination afterwards.
Category
Treatment - Drugs
2
Description
Control group: The second patient with a unique code (2) would be given package B (include artificial tear drop). Patients would instil a drop of artificial tear drop, with trademark of Artelac, in eye every 6 hours and would continue for 1 month. After 1 month they would return for examination.