Our aim in this study is to evaluate the effects of anti-supression therapy on binoculaity and stereopsis in postoperative constant exotropia patients. In a non-randomized, non-blinded, unicenteral clinical trial, 15 patients from both genders who had undergone a surgery to correct exotropia will be invited by phone call to participate in the study. Key inclusion criteria are to have history of operation to correct constant exotropia; to be 10 to 30 year-old; to have severe amblyopia and key exclusion criteria are to be mentally or physically handicapped; to have a concomitant eye disease such as uveitis, cataract or nystgmus; to have tropia over 10 prism dioptre. Patients would perform some anti-supression therapy exercises using major amblyoscope to improve their awareness of the supressed image on the retina of supressed eye for a 1-month period. Fusion status together with the stereopsis level would be measured and recorded before and after the intervention to make comparisons.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203039197N1
Registration date:2012-03-07, 1390/12/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-03-07, 1390/12/17
Registrant information
Name
Davood Gharabaghi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1330 8362
Email address
gharabaghid@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Faculty of Medicine
Tabriz University of Medical Sciences
Expected recruitment start date
2011-12-26, 1390/10/05
Expected recruitment end date
2012-06-08, 1391/03/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of anti-suppression therapy on binoculaity and stereopsis in postoperative constant exotropia patients
Public title
Does anti-supression therapy affect improvment of binocuarity and stereopsis?
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (to have history of operation to correct constant exotropia; to be 10 to 30 year-old; to have severe amblyopia; to have visual acuity over 20/200)
Exclusion criteria: (to be mentally or physically handicapped; to have a concomitant eye disease such as uveitis, cataract or nystgmus; to have tropia over 10 prism dioptre)
Age
From 10 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
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 Tabriz Medcal University
Street address
Vice chancellor for research, Tariz Medical University
City
Tabriz
Postal code
Approval date
2011-12-24, 1390/10/03
Ethics committee reference number
9089
Health conditions studied
1
Description of health condition studied
Constant exotropia
ICD-10 code
H50.1
ICD-10 code description
Divergent concomitant strabismus
Primary outcomes
1
Description
Stereopsis level
Timepoint
Iimmediately before the intervention, immediately after the end of the 1-month period of intervention
Method of measurement
Randot test
2
Description
Fusion status
Timepoint
Iimmediately before the intervention, immediately after the end of the 1-month period of intervention
Method of measurement
Using worth-4-dot test
Secondary outcomes
empty
Intervention groups
1
Description
Patients would perform some anti-supression therapy exercises using major amblyoscope to improve their awareness of the supressed image on the retina of supressed eye 3 times a week for half an hour in each session and for a 1-month period.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Nikoukari Eye Hospital
Full name of responsible person
Davoud Gharabaghi
Street address
Nikoukari hospital, Abbasi street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research
Full name of responsible person
Alireza Ostad Rahimi
Street address
Vice chancellor for research, Tabriz Medical University, Daneshgah square
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research
Proportion provided by this source
100
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
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz Medical Univesity
Full name of responsible person
Babak Rahimi
Position
Resident of ophthalmology
Other areas of specialty/work
Street address
Nikoukari hopital, Abbasi street
City
Tabriz
Postal code
Phone
+98 41 1655 1331
Fax
Email
ba.rahimi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz Medical University
Full name of responsible person
Davoud Gharabaghi
Position
Ophthalmologist, professor
Other areas of specialty/work
Street address
Nikoukari eye hospital, Abbasi street
City
Tabriz
Postal code
Phone
+98 41 1655 1331
Fax
Email
gharabaghid@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz Medical University
Full name of responsible person
Babak Rahimi
Position
Ophhalmology resident
Other areas of specialty/work
Street address
Nikoukari eye hospital, Abbasi street
City
Tabriz
Postal code
Phone
Fax
Email
ba.rahimi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)