AmblyopiaNCT01791946
Binocular Treatment of Amblyopia Before and After Strabismus Surgery
A study testing Binocular Treatment in people with Amblyopia and Strabismus, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
Trial summary
The primary objective of this study is to assess the effectiveness of an investigational binocular treatment in improving vision in strabismic amblyopes (i.e., patients with lazy eye, or poor vision in one eye due to a present or former eye misalignment). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Amblyopia, Strabismus
- What is being tested?
- Binocular Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Sep 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presence of amblyopia in one eye due to congenital strabismus.
- Amblyopic eye has a fully-corrected visual acuity of 20/30 or less with no other cause for the visual loss except amblyopia.
- Patient is 18 to 60 years old.
- Corrected vision in other eye is normal.
- Eligible for strabismus surgery or has completed it previously with a successful outcome, as determined by the treating physician.
- Available and willing to comply with examination procedures and schedule.
- Signed and dated informed consent.
Who cannot join
- Fully-corrected visual acuity of less than 20/30 in both eyes.
- Visual decrement due to anything other than amblyopia.
- At high risk for developing intractable diplopia (double vision) if vision in weak eye is improved. (To be determined by treating physician.)
- Unable or unavailable to complete at least 18 hours of binocular treatment over the course of six weeks.
- Currently enrolled in another research study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
About this study
The primary objective of this study is to assess the effectiveness of an investigational binocular treatment in improving vision in strabismic amblyopes (i.e., patients with lazy eye, or poor vision in one eye due to a present or former eye misalignment). Patients will be randomized to receive the study treatment either before or after strabismus surgery (i.e., corrective eye alignment surgery) or sham treatment before surgery. The study hypothesis is that there will be no significant change in vision in neither the pre nor post-surgery groups and no significant change in vision in neither the sham nor actual treatment groups.
Read the detailed description
This is a placebo-controlled, partially-randomized clinical trial. The patients will be assigned to one of two groups, Treatment Group A or Treatment B group. To help minimize bias, a blinded staff member will perform the visual acuity assessments throughout the study. The PI and Sub-I's will remain blinded to the treatment groups so that they may perform the visual exams throughout the study, if necessary.
Patients who have had strabismus surgery prior to being recruited will be allowed to participate in the study and, if eligible, will be automatically assigned to Treatment Group A.
Patients who are scheduled to have strabismus surgery at least six weeks from their screening clinic visit will be allowed to participate, once eligibility is determined. These patients will be included in Treatment Group B and randomized to either actual treatment or sham treatment. Each eligible participant will be included in the study and blinded as to which treatment group s/he has been assigned.
The duration of each subject's participation in the study will be about 7.5 months. All subjects will have a baseline visit to assess eligibility. Subjects in Treatment Group A will undergo strabismus surgery, if it was not previously performed, followed by 6 weeks of binocular treatment and a 3-6 month follow-up period. NOTE: There will be 4-6 weeks between surgery and the start of treatment to allow for full post-surgery recovery before starting treatment. Subjects in Treatment Group B will undergo 6 weeks of treatment/sham followed by strabismus surgery and a 3-6 month follow-up period.
If a treatment effect on vision is found, participants enrolled in the sham treatment arm will be offered the binocular treatment at the conclusion of the study and following surgery. Sham participants will be allowed to receive the study treatment so long as they have completed the study and there is no presence of any new medical condition following surgery that would be considered reasons for exclusion by the treating physician.
- Conditions
- Amblyopia, Strabismus
- Being tested
- Binocular Treatment, Sham Binocular Treatment
- Keywords
- lazy eye, cross eye, cross eyed
- Medical subject headings
- Amblyopia, Strabismus, Esotropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binocular TreatmentProcedure or surgery
The binocular treatment involves the completion of visual tasks via virtual reality goggles. The stimulus is presented to each eye separately, allowing for varying levels of contrast to be presented to each eye. (The visual task is therefore made more or less difficult with the variation of contrast presented to either eye.) Subjects will complete the computer-based visual tasks for approximately 36 hours total over the course of six weeks, or six hours per week for six weeks.
Sham Binocular TreatmentProcedure or surgery
The sham treatment involves the same computer-based visual tasks and timeframe as the binocular treatment training but there will be no variation in contrast presentation to either eye.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A (Post-Surgery) | Experimental | Subjects enrolled in this arm will first have eye alignment corrective surgery and then complete six weeks of the investigational binocular treatment training. Receives: Procedure: Binocular Treatment |
| Treatment Group B (Pre-Surgery) | Experimental | Subjects enrolled in this arm will first complete six weeks of the investigational binocular treatment training and then have eye alignment corrective surgery. Receives: Procedure: Binocular Treatment |
| Sham Treatment | Sham comparator | Subjects enrolled in this arm will first complete six weeks of the sham binocular treatment and then undergo eye alignment corrective surgery. Receives: Procedure: Sham Binocular Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome variable is a composite of the difference in visual acuity and stereo vision measurements taken before binocular treatment and strabismus surgery versus after binocular treatment and strabismus surgery.
Measured: This is a change outcome measure. That is measurements will be taken at baseline, 6 weeks, and approximately 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dean Cestari, M.D., Principal investigator, Massachusetts Eye and Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01791946
- Sponsor's protocol ID
- 12-186H
- Status last verified
- Oct 2015
- First submitted
- 7 Feb 2013
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: We do not \[plan on sharing IPD with other researchers.
Publications
Hess RF, Mansouri B, Thompson B. Restoration of binocular vision in amblyopia. Strabismus. 2011 Sep;19(3):110-8. doi: 10.3109/09273972.2011.600418.
PubMed 21870914Hess RF, Mansouri B, Thompson B. A new binocular approach to the treatment of amblyopia in adults well beyond the critical period of visual development. Restor Neurol Neurosci. 2010;28(6):793-802. doi: 10.3233/RNN-2010-0550.
PubMed 21209494
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Binocular Treatment of Amblyopia Before and After Strabismus Surgery
- ClinicalTrials.gov ID
- NCT01791946
- Acronym / sponsor ID
- 12-186H
- Conditions
- Amblyopia, Strabismus
- Keywords
- lazy eye, cross eye, cross eyed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 15 Feb 2013 (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.
The primary objective of this study is to assess the effectiveness of an investigational binocular treatment in improving vision in strabismic amblyopes (i.e., patients with lazy eye, or poor vision in one eye due to a present or former eye misalignment). Patients will be randomized to receive the study treatment either before or after strabismus surgery (i.e., corrective eye alignment surgery) or sham treatment before surgery. The study hypothesis is that there will be no significant change in vision in neither the pre nor post-surgery groups and no significant change in vision in neither the sham nor actual treatment groups.
Detailed description
This is a placebo-controlled, partially-randomized clinical trial. The patients will be assigned to one of two groups, Treatment Group A or Treatment B group. To help minimize bias, a blinded staff member will perform the visual acuity assessments throughout the study. The PI and Sub-I's will remain blinded to the treatment groups so that they may perform the visual exams throughout the study, if necessary.
Patients who have had strabismus surgery prior to being recruited will be allowed to participate in the study and, if eligible, will be automatically assigned to Treatment Group A.
Patients who are scheduled to have strabismus surgery at least six weeks from their screening clinic visit will be allowed to participate, once eligibility is determined. These patients will be included in Treatment Group B and randomized to either actual treatment or sham treatment. Each eligible participant will be included in the study and blinded as to which treatment group s/he has been assigned.
The duration of each subject's participation in the study will be about 7.5 months. All subjects will have a baseline visit to assess eligibility. Subjects in Treatment Group A will undergo strabismus surgery, if it was not previously performed, followed by 6 weeks of binocular treatment and a 3-6 month follow-up period. NOTE: There will be 4-6 weeks between surgery and the start of treatment to allow for full post-surgery recovery before starting treatment. Subjects in Treatment Group B will undergo 6 weeks of treatment/sham followed by strabismus surgery and a 3-6 month follow-up period.
If a treatment effect on vision is found, participants enrolled in the sham treatment arm will be offered the binocular treatment at the conclusion of the study and following surgery. Sham participants will be allowed to receive the study treatment so long as they have completed the study and there is no presence of any new medical condition following surgery that would be considered reasons for exclusion by the treating physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A (Post-Surgery) | Experimental | Procedure: Binocular TreatmentSubjects enrolled in this arm will first have eye alignment corrective surgery and then complete six weeks of the investigational binocular treatment training. |
| Treatment Group B (Pre-Surgery) | Experimental | Procedure: Binocular TreatmentSubjects enrolled in this arm will first complete six weeks of the investigational binocular treatment training and then have eye alignment corrective surgery. |
| Sham Treatment | Sham comparator | Procedure: Sham Binocular TreatmentSubjects enrolled in this arm will first complete six weeks of the sham binocular treatment and then undergo eye alignment corrective surgery. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Presence of amblyopia in one eye due to congenital strabismus.
- Amblyopic eye has a fully-corrected visual acuity of 20/30 or less with no other cause for the visual loss except amblyopia.
- Patient is 18 to 60 years old.
- Corrected vision in other eye is normal.
- Eligible for strabismus surgery or has completed it previously with a successful outcome, as determined by the treating physician.
Key exclusion criteria (5 listed)
- Fully-corrected visual acuity of less than 20/30 in both eyes.
- Visual decrement due to anything other than amblyopia.
- At high risk for developing intractable diplopia (double vision) if vision in weak eye is improved. (To be determined by treating physician.)
- Unable or unavailable to complete at least 18 hours of binocular treatment over the course of six weeks.
- Currently enrolled in another research study.
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 |
|---|---|---|
| Binocular TreatmentThe binocular treatment involves the completion of visual tasks via virtual reality goggles. The stimulus is presented to each eye separately, allowing for varying levels of contrast to be presented to each eye. (The visual task is therefore made more or less difficult with the variation of contrast presented to either eye.) Subjects will complete the computer-based visual tasks for approximately 36 hours total over the course of six weeks, or six hours per week for six weeks. | Procedure or surgery | Treatment Group A (Post-Surgery), Treatment Group B (Pre-Surgery) |
| Sham Binocular TreatmentThe sham treatment involves the same computer-based visual tasks and timeframe as the binocular treatment training but there will be no variation in contrast presentation to either eye. | Procedure or surgery | Sham Treatment |
Primary outcome
The primary outcome variable is a composite of the difference in visual acuity and stereo vision measurements taken before binocular treatment and strabismus surgery versus after binocular treatment and strabismus surgery.
Time frame: This is a change outcome measure. That is measurements will be taken at baseline, 6 weeks, and approximately 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2017.
- Results publication: PubMed 21870914Hess RF, Mansouri B, Thompson B. Restoration of binocular vision in amblyopia. Strabismus. 2011 Sep;19(3):110-8. doi: 10.3109/09273972.2011.600418.
- Results publication: PubMed 21209494Hess RF, Mansouri B, Thompson B. A new binocular approach to the treatment of amblyopia in adults well beyond the critical period of visual development. Restor Neurol Neurosci. 2010;28(6):793-802. doi: 10.3233/RNN-2010-0550.
- Individual participant dataSharing planned: No. We do not [plan on sharing IPD with other researchers.
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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.
Dean Cestari, M.D. principal investigator
Massachusetts Eye and Ear Infirmary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Binocular Treatment in people with Amblyopia and Strabismus, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 13 Jan 2017. 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 United States. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome variable is a composite of the difference in visual acuity and stereo vision measurements taken before binocular treatment and strabismus surgery versus after binocular treatment and strabismus surgery. (time frame: This is a change outcome measure. That is measurements will be taken at baseline, 6 weeks, and approximately 3 months.). 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 NCT01791946, which also lists 2 linked publications.
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 13 Jan 2017.