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The Role of Interactive Binocular Treatment System in Amblyopia Therapy

Primary Purpose

Amblyopia

Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Patching Therapy
Interactive Binocular Treatment System
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amblyopia focused on measuring Amblyopia, Interaction Binocular Treatment (I-BiTTM), Patch Therapy

Eligibility Criteria

4 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BCVA <= 0.3 LogMAR

Exclusion Criteria:

  • Organic Amblyopia
  • Age less than 4 years
  • Nystagmus

Sites / Locations

  • Islamic Republic of IranRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Recommendation of Patching

Recommendation of Patching and interactive binocular treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Best Corrected Visual Acuity, Stereopsis
Two arms were under patching and Interactive Binocular Treatment (IBIT)

Secondary Outcome Measures

Full Information

First Posted
April 6, 2016
Last Updated
April 14, 2016
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02740725
Brief Title
The Role of Interactive Binocular Treatment System in Amblyopia Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia
Keywords
Amblyopia, Interaction Binocular Treatment (I-BiTTM), Patch Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Recommendation of Patching
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Recommendation of Patching and interactive binocular treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Patching Therapy
Intervention Description
Occlusion of a dominant eye with better best corrected visual acuity
Intervention Type
Device
Intervention Name(s)
Interactive Binocular Treatment System
Intervention Description
Dissociation of two eyes with more foveal stimulation to the amblyopic eye
Primary Outcome Measure Information:
Title
Best Corrected Visual Acuity, Stereopsis
Description
Two arms were under patching and Interactive Binocular Treatment (IBIT)
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BCVA <= 0.3 LogMAR Exclusion Criteria: Organic Amblyopia Age less than 4 years Nystagmus
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hamideh Sabbaghi, MS
Phone
+98 912 02805930
Email
sabbaghi_h@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hamideh Sabbaghi, MS
Phone
+9891554518406
Email
sabbaghi_h@sbmu.ac.ir
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhale Rajavi, Professor
Organizational Affiliation
Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Official's Role
Study Director
Facility Information:
Facility Name
Islamic Republic of Iran
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hamideh Sabbaghi, MS
Phone
+989120285930
Email
sabbaghi_h@yahoo.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
27830207
Citation
Rajavi Z, Sabbaghi H, Amini Sharifi E, Behradfar N, Yaseri M. The role of Interactive Binocular Treatment system in amblyopia therapy. J Curr Ophthalmol. 2016 Aug 9;28(4):217-222. doi: 10.1016/j.joco.2016.07.005. eCollection 2016 Dec.
Results Reference
derived

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The Role of Interactive Binocular Treatment System in Amblyopia Therapy

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