Binocular Treatment of Amblyopia Before and After Strabismus Surgery
| Status: | Completed |
|---|---|
| Conditions: | Ocular, Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 1/14/2017 |
| Start Date: | January 2013 |
| End Date: | September 2016 |
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.
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.
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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