Study of the effect of atropine eye drops with concentration of 0.1%&0.01% and placebo in natural course of myopia progression in Children with 6 to 18 year olds
Comparison of the effects of 0.1% and 0.01% concentrations of atropine eye drops and placebo on myopic diopter progression in persons with 6 -18 years old
Design
Patients (6-18 years old) with diagnosis of myopia (2-6 diopter) with inclusion criteria will be studied. In first phase of study (treatment phase) 93 pateints with 6-18 years old and diagnosis of myopia 2 diopter or more devided in three droups. First group, 31 patients will receive atropine eye drop (0.1%) in each eye every night for 12 months. In second phase atropine will be stopped and and the patients will follow for 6 months.
Second group is similar to first group but will receive atropine eye drop 0.01%.
Third group (control group) are 31 patients that will treat with Tirlose artificial eye drop in the bottle of atropine. In second phase artificial eye drop will be stopped and and the patients will follow for 6 months
Settings and conduct
The study will be done in eye clinic of Amiralmomenin Hospital in Rasht. This study will be double blind for patients and researcher .
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) 6-18 age
2) Myopia or astigmatism (2-6 diopter)
3) No amblyopia
Exclusion criteria:
1) over 18 and under 6 years old
2) Amblyopia
3) Strabismus
Intervention groups
First group, 31 patients will receive atropine eye drop (0.1%) every night for 12 months. In second phase atropine will be stopped and and the patients will follow for 6 months. Second group is similar to first group but will receive atropine eye drop 0.01%.Third group (control group) are 31 patients that will treat with artificial eye drop. In second phase artificial eye drop will be stopped and and the patients will follow for 6 months.
Main outcome variables
percent of myopic power and axial length changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100414003714N3
Registration date:2018-07-10, 1397/04/19
Registration timing:registered_while_recruiting
Last update:2018-07-10, 1397/04/19
Update count:0
Registration date
2018-07-10, 1397/04/19
Registrant information
Name
Abdolreza medghalchi
Name of organization / entity
guilan medical science university
Country
Iran (Islamic Republic of)
Phone
01317756898-2238306-8
Email address
rezamed1340@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-20, 1397/03/30
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of atropine eye drops with concentration of 0.1%&0.01% and placebo in natural course of myopia progression in Children with 6 to 18 year olds
Public title
Effect of atropine eye drop for inhibition of myopic progression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
aged 6-18
Myopia astigmatism (2-6 diopter)
No amblyopia
Exclusion criteria:
Age under 6 and over 18
Amblyopia
Strabismus
Age
From 6 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
31
More than 1 sample in each individual
Number of samples in each individual:
31
First group will receive atropin eye drop 0.1%, second group will receive atropin eye drop 0.01% and third group will receive placebo.
Randomization (investigator's opinion)
Randomized
Randomization description
Random Allocation will be done according block randomization of 16 blocks of 6. Initially this randomization is depended on gradual presentation and put into secured pocket and keep in research center.
Blinding (investigator's opinion)
Double blinded
Blinding description
ِDoctor and patients are not aware of dose and kind of eye drops. Only research center staff knows the subject.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe of Guilan University of Medical Sciences
Street address
Eye Research Center, Amiralmomenin Hospital, 17 Shahrivar ST, Rasht
City
Rasht
Province
Guilan
Postal code
41396-37459
Approval date
2018-06-11, 1397/03/21
Ethics committee reference number
IR.GUMS.REC.1397.106
2
Ethics committee
Name of ethics committee
Guilan university of medical sciences ethics committees
Street address
Eye research center,Rasht, 17 shahrivar St, Amiralmomenin Hospital
City
Rasht
Province
Guilan
Postal code
41396-37459
Approval date
2018-06-11, 1397/03/21
Ethics committee reference number
IR.GUMS.REC.1397.106
Health conditions studied
1
Description of health condition studied
Inhibition of myopic progression with using atropine eye drop
ICD-10 code
H52.1
ICD-10 code description
Myopia
Primary outcomes
1
Description
percent of myopic power and axial length changes
Timepoint
6 months after discontinuation of atropine 0.1% and 0.01% eye drop and placebo
Method of measurement
Auto refractometer and ultrasound
Secondary outcomes
1
Description
Myopic power and axial length changes 6 months after treatment withdrawal
Timepoint
6 months after discontinuation of atropine 0.1% and 0.01% eye drop and
Method of measurement
Auto refractometer and ultrasound
Intervention groups
1
Description
Intervention group 1: Receive 0.1% atropine eye drops