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The Role of Interactive Binocular Treatment System in Amblyopia Therapy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02740725
Enrollment
50
Registered
2016-04-15
Start date
2014-12-31
Completion date
Unknown
Last updated
2016-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amblyopia

Keywords

Amblyopia, Interaction Binocular Treatment (I-BiTTM), Patch Therapy

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.

Interventions

DEVICEInteractive Binocular Treatment System

Dissociation of two eyes with more foveal stimulation to the amblyopic eye

Occlusion of a dominant eye with better best corrected visual acuity

Sponsors

Shahid Beheshti University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
No

Inclusion criteria

* BCVA \<= 0.3 LogMAR

Exclusion criteria

* Organic Amblyopia * Age less than 4 years * Nystagmus

Design outcomes

Primary

MeasureTime frameDescription
Best Corrected Visual Acuity, Stereopsis30 daysTwo arms were under patching and Interactive Binocular Treatment (IBIT)

Countries

Iran

Contacts

Primary ContactHamideh Sabbaghi, MS
sabbaghi_h@yahoo.com+98 912 02805930
Backup ContactHamideh Sabbaghi, MS
sabbaghi_h@sbmu.ac.ir+9891554518406

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026