Protocol summary

Study aim
Determining the effect of atropine 0.025% on the angle of deviation and indices of accommodation and vergence system in students aged 18 to 25 years.
Design
A controlled, parallel-group, single-blind, randomized, phase 3 clinical trial on 42 individuals aged 18 to 25 years.
Settings and conduct
Faculty students with age range of 18 to 25 years who meet the study entry and exit criteria and have completed the consent form are included in this study and their examinations are done in the faculty clinic. In the intervention group, 0.025% atropine are poured every night before going to bed at a specific time, and the control group is asked to use artificial tear drops in the same way. In order to blind, atropine drops are poured into artificial tear containers so that people are blind in terms of the type of drop. Visual acuity, refractive error, and all indicators of the accommodation and vergence system will be measured and compared before and one week after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: person with 18 to 25 years, best corrected visual acuity of 20/20, Normal binocular vision Exclusion criteria: history of eye symptoms caused by close work, diplopia or blurred vision, history of strabismus, amblyopia or pathological eye diseases
Intervention groups
This study includes two groups. One group drop 0.025% atropine in each eye every night and is the intervention group, which is supposed to investigate the effect of this drug on all aspects of the vergence and accommodation system. The second group is the control group, who put one drop of artificial tears in each eye every night.
Main outcome variables
The amount of changes in the amplitude of accommodation , the amount of ocular deviation in far and near

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230626058588N2
Registration date: 2024-11-08, 1403/08/18
Registration timing: retrospective

Last update: 2024-11-08, 1403/08/18
Update count: 0
Registration date
2024-11-08, 1403/08/18
Registrant information
Name
farzaneh Dehghanian Nasrabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7124
Email address
fdehghanian1991@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 0.025 % Atropine on the accommodation and vergence indices in students range of age 18 to 25 years old.
Public title
Effect of low dose Atropine on ocular accommodation and vergence system
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 25 years old best correction visual acuity 20/20 stereo acuity maximum 40 second anisometropia lower than 2 diopters
Exclusion criteria:
history of ocular surgery history of ocular symptoms with near work history of transient blurred vision or diplopia history of strabismus and amblyopia history of ocular pathology
Age
From 18 years old to 25 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 42
Randomization (investigator's opinion)
Randomized
Randomization description
for randomize using randomization programs available on the Internet, the numbers 1 to 42 were randomly assigned to two groups A and B, and the prepared list is as follows. To assign labels A and B to the low-dose Atropine and artificial tear drop intervention group, a coin toss lottery was used, and group B was determined as the intervention group (use of Atropine) and group A was determined as the control group (artificial tears).Since each number is randomly assigned to a group A or B, each person who have inclusion criteria and enters the study is placed in one of the groups according to the randomization table. According to the sample volume, if the drop is determined. If the drop is more than the number included, the ITT (Intention To Treat) method will be used.
Blinding (investigator's opinion)
Single blinded
Blinding description
After randomizing, the low dose atropine was prepared and poured into the container that it look exactly like artificial tear drops and in this way the participants were blinded to the type of drops used.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Hemat Highway next to Milad Tower
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2024-06-26, 1403/04/06
Ethics committee reference number
IR.IUMS.REC.1403.281

Health conditions studied

1

Description of health condition studied
Heterophoria
ICD-10 code
H50.5
ICD-10 code description
Heterophoria

Primary outcomes

1

Description
Accommodation indicators
Timepoint
One week after dripping of 0.025% atropine
Method of measurement
Near E chart, Minus & positive

2

Description
Vergence indicators
Timepoint
One week after dripping of 0.025% atropine
Method of measurement
positive and negative fusional vergence, near point of vergence, cover test

Secondary outcomes

1

Description
Refractive error
Timepoint
One week after dripping of 0.025% atropine drops
Method of measurement
Retinoscopy method and autorefractometer

2

Description
Visual acuity
Timepoint
One week after dripping of 0.025% atropine drops
Method of measurement
Log MAR chart at 6 m and 40 cm

Intervention groups

1

Description
Intervention group: Atropine drops with a dose of 0.025% are poured into each eye every night for a week. In order to prepare a dose of 0.025%, one milliliter of 0.5% (produced by Sina Daru Company) atropine drops is combined with 10 milliliters of artificial tears(produced by Sina Daru Company) and poured into a container similar to the container of artificial tears.
Category
Diagnosis

2

Description
Control group: Artificial tear drops (produced by Sina Daru Company) are poured into each eye every night for a week.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Faculty of Rehabilitation of Iran University of Medical Sciences of IranRehabilitation of
Full name of responsible person
Dr. Ali Mirzajani
Street address
Mirdamad Madar Square, Shah Nazari Street, Madadkaran Street, School of Faculty of Rehabilitation of Iran University of Medical Sciences of Iran
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 2059
Email
rehab@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Ali Mirzajani
Street address
Mirdamad, Mader Square, Shah Nazari St., Maddkaran St., Faculty of Rehabilitation Sciences, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 2059
Email
mirzajani.a@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
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
Iran University of Medical Sciences
Full name of responsible person
Dr. Ali Mirzajani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Optometry
Street address
Mirdamad, Mader Square, Shah Nazari St., Maddkaran St., Faculty of Rehabilitation Sciences, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 2059
Email
mirzajani.a@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Ali Mirzajani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Optometry
Street address
Mirdamad, Mader Square, Shah Nazari St., Maddkaran St., Faculty of Rehabilitation Sciences, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 2059
Email
mirzajani.a@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farzaneh Dehghanian Nasrabadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Optometry
Street address
Mirdamad, Mader Square, Shah Nazari St., Maddkaran St., Faculty of Rehabilitation Sciences, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 2059
Email
Fdehghanian1991@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after de-identifying sample
When the data will become available and for how long
Data access period 4 months after publication of results
To whom data/document is available
Researchers in academic and scientific institutions
Under which criteria data/document could be used
In order to more closely examine the characteristics of the sample and the effects of the drop and on the indices of the Accommodation and vergence system. Academics and researchers can request to receive data.The requester can perform any analysis on the data, citing its source and obtaining permission to express it in studies or articles. To send a request, it is enough to send an email to Dr. Mirzajani or Ms. Farzaneh Dehghanian.
From where data/document is obtainable
Farzaneh Dehghanian Nasrabadi fdehghanian1991@gmail.com
What processes are involved for a request to access data/document
By sending an email to Mrs. Farzaneh Dehghanian and mentioning which scientific institute they are working in
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