To compare the effect of Cambridge vision stimulator (CAM) therapy with passive occlusion therapy in the management of unilateral amblyopia.
Design
Clinical trial with control group, with parallel groups, randomized, phase 2 on 100 patients. A flipping-coin is used for randomization.
Settings and conduct
All participants will be recruited from first diagnosed unilateral amblyopic children referred to the eye center for managing amblyopia in Ruaa optometry clinic, Najaf, Iraq. The main provision of the study will be recruiting those patients who have not been previously received any amblyopia treatment modality.
We will record the pre-and post-amblyopia treatment data of patients who will have been followed for three months after CAM therapy and passive occlusion therapy. At the first stage, all selected candidates whose amblyopia has not been managed previously will be corrected. The collected data during the baseline and follow-up examination sessions are included demographic characteristics, uncorrected and corrected distance visual acuity (UDVA and CDVA) using a standard Snellen chart within a 6-meter distance, spherical objective cyclo-refraction.
Participants/Inclusion and exclusion criteria
- Inclusion criteria
Children between 4-10-year-old; Patients with unilateral functional amblyopia (due to anisometropia and/or strabismus); Patients who will be newly diagnosed with amblyopia and will be received their first management strategy; Patients with CDVA worse than 0.8 (20/25)
- Exclusion criteria
Patients with organic amblyopia; Presence of systemic diseases affecting ocular anatomy and function; Patients with a history of amblyopia management and strabismus surgery; Children a premature birth
Intervention groups
Amblyopia treatment by painting on CAM device and occlusion therapy group
Main outcome variables
Uncorrected and best-corrected visual acuity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221009056119N1
Registration date:2023-01-21, 1401/11/01
Registration timing:retrospective
Last update:2023-01-21, 1401/11/01
Update count:0
Registration date
2023-01-21, 1401/11/01
Registrant information
Name
Masoud Khorrami Nejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 3939
Email address
mkhorraminejad@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-06, 1401/06/15
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of CAM therapy with passive occlusion therapy in the management of unilateral amblyopia
Public title
Comparison of CAM therapy with occlusion therapy in the unilateral amblyopia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children between 4-10-year-old
Patients with unilateral functional amblyopia (due to anisometropia and/or strabismus)
Patients who will be newly diagnosed with amblyopia and will be received their first management strategy
Patients with CDVA worse than 0.8 (20/25)
Exclusion criteria:
Patients with organic amblyopia
Patients with a history of strabismus surgery
Age
From 4 years old to 10 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
The method of simple randomization is flipping a coin
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran university of medical sciences
Street address
Nursing And Midwifery School, Tehran University Of Medical Science
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2022-08-14, 1401/05/23
Ethics committee reference number
IR.TUMS.FNM.REC.1401.103
Health conditions studied
1
Description of health condition studied
Refractive amblyopia
ICD-10 code
H53.02
ICD-10 code description
Refractive amblyopia
Primary outcomes
1
Description
The amount of uncorrected and best-corrected distance visual acuity
Timepoint
1, 2 and 3 months after amblyopia treatment
Method of measurement
Using E Snellen visual acuity chart
Secondary outcomes
empty
Intervention groups
1
Description
In the CAM procedure, five discs with different spatial frequencies (SF) (2, 6, 15, 20, 30 cycle/degree) will be presented to the patient (30 minutes, twice a week). Plates with SF equal to the two lines better than the measured baseline CDVA will be chosen. Total period of treatment is 3 months.
Category
Treatment - Devices
2
Description
According to the guidelines of Amblyopia Treatment Studies (ATS), the standard occlusion therapy protocols, in the control group, will be as follows: In patients with severe amblyopia (CDVA worse than 20/100 or 0.8 logMAR) will be instructed to patch the non-amblyopic eye 6 hours a day, and patients with moderate amblyopia (CDVA between 20/80-20/40 or 0.3-0.8 logMAR) and mild amblyopia (CDVA between 20/40-20/25 or 0.2-0.3 logMAR) will be instructed to patch the non-amblyopic eye 2 hours a day without any extra visual training. Total period of treatment is 3 months.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ruaa optometry clinic
Full name of responsible person
Ruaa Abdulrahman
Street address
Ruaa optometry clinic, Najaf, Iraq
City
Najaf
Postal code
1111111111
Phone
+964 37 710 1525
Email
dr.khorraminejad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoud Khorrami-Nejad
Street address
Tehran, District 12, Enghelab St، Pich-e-Shemiran
City
Tehran
Province
Tehran
Postal code
6511111489
Phone
+98 912 376 6221
Email
dr.khorraminejad@gmail.com
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 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
Tehran University of Medical Sciences
Full name of responsible person
Masoud Khorrami-Nejad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Optometry
Street address
District 12, Enghelab St، Pich-e-Shemiran
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
77533939
Email
dr.khorraminejad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoud Khorrami-Nejad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Optometry
Street address
District 12, Enghelab St، Pich-e-Shemiran
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
77533939
Email
dr.khorraminejad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoud Khorrami-Nejad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Optometry
Street address
District 12, Enghelab St، Pich-e-Shemiran
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
77533939
Email
dr.khorraminejad@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Not applicable
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts after the results are published
To whom data/document is available
All pepole
Under which criteria data/document could be used
Comparison of results in other races and countries
From where data/document is obtainable
Address: Tehran, ٍEnghelab St., Pich Shamiran, corner of Safi Alishah St., Faculty of Rehabilitation
Postal code: 11489-65111 - PO Box: 11365-1683
Dr. Masoud Khorminejad
What processes are involved for a request to access data/document