To determine the effect of combined treatment with atropine and patching in comparison to patching alone in the treatment of amblyopia in children
Design
In this clinical trial study, after approval of the proposal and obtaining ethics approval from the Shahid Beheshti University of Medical Sciences, children aged 3 to 17 years with strabismus amblyopia or anisometropic amblyopia who either had inadequate response or insufficient compliance with previous patch therapy were divided into two groups.
Fifty patients received atropine 1% therapy for 3 months (every night except Fridays and Saturdays), while patch therapy for the healthy eye was only continued in cases where it was already being used. The other 50 patients continued their patch therapy along with atropine treatment. Changes in visual acuity (VA) in the amblyopic eye were assessed at 3 and 6 months. The primary variable was BCVA, and secondary variables included age, cause of amblyopia, prior amblyopia treatment before starting the current therapy, type of refractive error, type of strabismus, and the patients' quality of life, which were reviewed and recorded in both groups.
Settings and conduct
Torfeh ophthalmology training center
Participants/Inclusion and exclusion criteria
Children aged 3 to 17 years with amblyopia due to strabismus, anisometropia, deprivation or combined
Intervention groups
50 patients in case group with atropine and patching
50 patients in control group with patching alone
Main outcome variables
Age
Sex
Weight
Visual acuity correction
children life quality
adverse effect of treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241003063251N1
Registration date:2024-12-09, 1403/09/19
Registration timing:registered_while_recruiting
Last update:2024-12-09, 1403/09/19
Update count:0
Registration date
2024-12-09, 1403/09/19
Registrant information
Name
Maryam Oraee Yazdani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 8023
Email address
maryam_o_yazdani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-05, 1403/09/15
Expected recruitment end date
2025-09-06, 1404/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Combined Atropine and Patch Therapies for Amblyopia treatment in Children aged 3-17 years old
Public title
The effect of atropine drops on the treatment of lazy eye in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children from 3 to 17 years of age referred to the strabismus clinic of Torfeh training center
Unilateral amblyopia and refractory to treatment due to strabismus or anisometropia or depreciative or combined
Failure to respond to previous patch therapy treatment means failure to improve BCVA at least two lines according to the Snellen chart after patch therapy for at least 6 months.
Exclusion criteria:
Children outside the age range of 3 to 17 years old
Non refractory amblyopia
Age
From 3 years old to 17 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
This study uses a simple randomization approach, dividing patients into two groups.one group(A) receives patch therapy alone, while the other group(B) receives patch therapy along with one drop pf 1% atropine, administered once a day for five days a week (excluding Thursday and Fridays) for 3 months and evaluation is done every three months. if the amblyopia improves and the BCVA of both eyes is equal, atropine is stopped, and patch therapy also gradually decreases and stops. if there is no response after 6 months, the treatment with atropine is stopped, and in patients who have a partial response to the treatment, the treatment with drops continues.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid beheshti university of medical science
Street address
Daneshjou Blvd., Velenjak, Shahid beheshti university of medical science
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2024-07-31, 1403/05/10
Ethics committee reference number
IR.SBMU.MSP.REC.1403.258
Health conditions studied
1
Description of health condition studied
Amblyopia
ICD-10 code
H-52
ICD-10 code description
Disorders of refraction and accommodation
Primary outcomes
1
Description
Corrected vision before treatment and 6 months after treatment
Timepoint
Before starting, 3 months later, 6 months after treatment
Method of measurement
logmar
Secondary outcomes
empty
Intervention groups
1
Description
Treatment group(A): treatment with patching alone
Category
Treatment - Drugs
2
Description
Treatment group(B): treatment with patching and atropine drop
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Torfeh hospital
Full name of responsible person
Mohadeseh Feizi
Street address
Torfeh Hospital, Baharestan, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1896836811
Phone
+98 21 7762 6550
Fax
Email
maryam_o_yazdani@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohadeseh Feizi
Street address
Shahid Beheshti University of Medical Sciences, Yemen street, Velenjak, Tehranvelenjak street
City
Tehran
Province
Tehran
Postal code
1162519165
Phone
+98 21 23871
Fax
Email
Info@sbmu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
No
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohadeseh Feizi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Shahid Beheshti University of Medical Sciences, Yemen Street, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1916511625
Phone
+98 21 23871
Email
mohadeseh_feizi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Oraee Yazdani
Position
Ophthalmology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Shahid Beheshti University of Medical sciences, Yemen Street, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1988873554
Phone
+98 21 2243 8023
Fax
Email
maryam_o_yazdani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Oraee Yazdani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
No. 2, Block 8, Mina Town, Mina Blvd, Zanbagh Blvd, Shahid Ehjazi square, Zaferaniye street
City
Tehran
Province
Tehran
Postal code
1988873554
Phone
+98 21 2243 8023
Fax
Email
maryam_o_yazdani@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available