Our study is an unmatched and triple masked uncontrolled clinical trial in which the aim of this study is to determine the effect of Timolol in improvement of myopic regression after LASIK surgery in Basir Clinic patients. 100 eyes are included in our study and are divided in two groups. The drug used for the cases is Timolol 0.5% ophthalmic drop which is used twice a day, once every 12 hours. The placebo which is used for the control eyes is artificial tear drop which is used with the same intervals. The outcomes that are studied in this project which are measured in each follow up are visual acuity, refractive errors, pachymetry and corneal topography. The patients will drop their tears for 6 months and will be followed two times: 2 months and then 6 months after the intervention. This study includes the patients that have already performed LASIK surgery and meanwhile both of their eyes have had at least -0.5 D regression. The exclusion criteria are presence of complications during the surgery, having had background diseases such as glaucoma, heart failure, digestive problems, cancer, favism, myasthenia gravis, or asthma.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138706271258N1
Registration date:2009-12-05, 1388/09/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-12-05, 1388/09/14
Registrant information
Name
Mohammad Mansouri
Name of organization / entity
Tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2205 6391
Email address
mmansouri@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Basir Eye Clinic, Tehran University of Medical Sciences
Expected recruitment start date
2009-04-07, 1388/01/18
Expected recruitment end date
2009-11-09, 1388/08/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Improvement of refractive outcomes in myopic regression after Laser in Situ Keratomileusis using timolol: A randomised clinical trial
Public title
Improvement of refractive outcomes in myopic regression after Laser in Situ Keratomileusis using timolol: A randomised clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having undergone Lasik surgery, both eyes have had at least -0.5 D return
Exclusion criteria: Incidence of complications during the surgery, presence of background diseases such as glaucoma, heart failure, digestive problems, cancer, favism, myasthenia gravis, or asthma
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran Univesity of Medical Sciences
Street address
6th floor, main building of Tehran Univesity of Medical Sciences, Keshavarz blvd and Ghods Ave. cross.
City
Tehran
Postal code
Approval date
2009-03-04, 1387/12/14
Ethics committee reference number
7581610387
Health conditions studied
1
Description of health condition studied
Regression after lasik surgery
ICD-10 code
H52.1
ICD-10 code description
Myopia
Primary outcomes
1
Description
Refractive error
Timepoint
before intervention; 2 months and 6 months after intervention
Method of measurement
auto refractive, objective refractive, subjective refractive
Secondary outcomes
empty
Intervention groups
1
Description
Timolol drop; every 12 hours for each eye; for 6 months
Category
Treatment - Drugs
2
Description
Artificial tear drop; every 12 hours for each eye; for 6 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Basir Eye Clinic
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Karimi
Street address
Tehran University of Medical Science building,Keshavarz boulevard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Science
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Basir Eye Clinic
Full name of responsible person
Dr. Shojaei
Street address
Basir Eye Clinic, Jamalzade street, Azadi Avenue
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?