AmblyopiaNCT02740725
The Role of Interactive Binocular Treatment System in Amblyopia Therapy
A study testing Patching Therapy and Interactive Binocular Treatment System in people with Amblyopia, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- Patching Therapy and Interactive Binocular Treatment System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- Dec 2014to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- BCVA <= 0.3 LogMAR
Who cannot join
- Organic Amblyopia
- Age less than 4 years
- Nystagmus
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Islamic Republic of Iran
Tehran
Hamideh Sabbaghi, MS, +989120285930, sabbaghi_h@yahoo.com
About this study
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.
Read the 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.
- Conditions
- Amblyopia
- Being tested
- Patching Therapy, Interactive Binocular Treatment System
- Keywords
- Amblyopia, Interaction Binocular Treatment (I-BiTTM), Patch Therapy
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patching TherapyOther
Occlusion of a dominant eye with better best corrected visual acuity
Interactive Binocular Treatment SystemDevice
Dissociation of two eyes with more foveal stimulation to the amblyopic eye
| Study group | Role | What they receive |
|---|---|---|
| Recommendation of Patching | Active comparator | 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. Receives: Other: Patching Therapy |
| Recommendation of Patching and interactive binocular treatment | Active comparator | 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. Receives: Other: Patching Therapy; Device: Interactive Binocular Treatment System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity, Stereopsis
Two arms were under patching and Interactive Binocular Treatment (IBIT)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startDec 2014
- Primary completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamideh Sabbaghi, Shahid Beheshti University of Medical Sciences
- Investigators
- Zhale Rajavi, Professor, Study director, Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740725
- Sponsor's protocol ID
- sbmu.rec.1393.591
- Status last verified
- Apr 2016
- First submitted
- 6 Apr 2016
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27830207
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Interactive Binocular Treatment System in Amblyopia Therapy
- ClinicalTrials.gov ID
- NCT02740725
- Acronym / sponsor ID
- sbmu.rec.1393.591
- Conditions
- Amblyopia
- Keywords
- Amblyopia, Interaction Binocular Treatment (I-BiTTM), Patch Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Nov 2016 (estimated)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recommendation of Patching | Active comparator | Other: Patching TherapyPatients 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. |
| Recommendation of Patching and interactive binocular treatment | Active comparator | Other: Patching Therapy, Device: Interactive Binocular Treatment SystemPatients 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. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- BCVA <= 0.3 LogMAR
Key exclusion criteria (3 listed)
- Organic Amblyopia
- Age less than 4 years
- Nystagmus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patching TherapyOcclusion of a dominant eye with better best corrected visual acuity | Other | Recommendation of Patching, Recommendation of Patching and interactive binocular treatment |
| Interactive Binocular Treatment SystemDissociation of two eyes with more foveal stimulation to the amblyopic eye | Device | Recommendation of Patching and interactive binocular treatment |
Primary outcome
Best Corrected Visual Acuity, Stereopsis
Time frame: 30 days
Two arms were under patching and Interactive Binocular Treatment (IBIT)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- Derived from this study: PubMed 27830207Rajavi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhale Rajavi, Professor study director
Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patching Therapy and Interactive Binocular Treatment System in people with Amblyopia, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hamideh Sabbaghi, MS (+98 912 02805930, sabbaghi_h@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected Visual Acuity, Stereopsis (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02740725, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2016.