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The Role of Interactive Binocular Treatment System in Amblyopia Therapy

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ClinicalTrials.gov Identifier: NCT02740725
Recruitment Status : Unknown
Verified April 2016 by Hamideh Sabbaghi, Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : April 15, 2016
Last Update Posted : April 15, 2016
Sponsor:
Information provided by (Responsible Party):
Hamideh Sabbaghi, Shahid Beheshti University of Medical Sciences

Brief Summary:

Purpose: of determining the role of Interactive Binocular Treatment (I-BiTTM) as a complementary method of patching in amblyopia therapy.

Materials and Methods: In this randomized clinical trial study, 50 unilateral amblyopic children (25 male/25 female) less than 10 years with either best corrected visual acuity (BCVA) ≤0.3 LogMAR (Logarithm minimum angle of resolution) in amblyopic eye or difference of VA≥2 lines between two eyes will be included. Patients will be classified in the case and control groups (25 in each), randomly. Patching will be recommended in both, cases will also received I-BiTTM. The child will be asked to play I-BiTTM games through glasses with conjugate colored filters. Patching was continued for one month more in both groups. VA and stereoacuity were measured at baseline, one month at the end of I-BiTTM treatment and one month after I-BiTTM treatment.


Condition or disease Intervention/treatment Phase
Amblyopia Other: Patching Therapy Device: Interactive Binocular Treatment System Not Applicable

Detailed Description:
In this clinical trial study, our case group will receive I-BiTTM in the format of three playing games which have been designed suitable to the age of our cases. The mechanism of I-BiTTM has been designed in three playing games with inducing more foveal stimulation for the amblyopic eye through presentation of movable targets with more detailed. In addition, unmovable targets will presented to the non-amblyopic eyes. Playing games were continued 30 minutes in each session for 5 days in each week within one month.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2014
Estimated Primary Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia

Arm Intervention/treatment
Active Comparator: Recommendation of Patching
Patients will receive two hours of patching in the case of one line difference of best corrected visual acuity(BCVA) between two eyes during one month.
Other: Patching Therapy
Occlusion of a dominant eye with better best corrected visual acuity

Active Comparator: Recommendation of Patching and interactive binocular treatment
Patients will receive interactive binocular treatment addition to patch therapy in the least of 4 to 5 days of a week within 20-30 minutes in each day during one month.
Other: Patching Therapy
Occlusion of a dominant eye with better best corrected visual acuity

Device: Interactive Binocular Treatment System
Dissociation of two eyes with more foveal stimulation to the amblyopic eye




Primary Outcome Measures :
  1. Best Corrected Visual Acuity, Stereopsis [ Time Frame: 30 days ]
    Two arms were under patching and Interactive Binocular Treatment (IBIT)



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BCVA <= 0.3 LogMAR

Exclusion Criteria:

  • Organic Amblyopia
  • Age less than 4 years
  • Nystagmus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02740725


Contacts
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Contact: Hamideh Sabbaghi, MS +98 912 02805930 sabbaghi_h@yahoo.com
Contact: Hamideh Sabbaghi, MS +9891554518406 sabbaghi_h@sbmu.ac.ir

Locations
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Iran, Islamic Republic of
Islamic Republic of Iran Recruiting
Tehran, Iran, Islamic Republic of
Contact: Hamideh Sabbaghi, MS    +989120285930    sabbaghi_h@yahoo.com   
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
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Study Director: Zhale Rajavi, Professor Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hamideh Sabbaghi, Shahid Beheshti Medical University, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02740725     History of Changes
Other Study ID Numbers: sbmu.rec.1393.591
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: April 2016

Keywords provided by Hamideh Sabbaghi, Shahid Beheshti University of Medical Sciences:
Amblyopia
Interaction Binocular Treatment (I-BiTTM)
Patch Therapy

Additional relevant MeSH terms:
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Amblyopia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms