BridgeMD
Compares treatment options for Amblyopia
Official title A Randomized Trial to Evaluate Sequential vs Simultaneous Patching
ClinicalTrials.gov ID: NCT04378790
What this study is testing
- What it's testing
- A randomized trial to determine whether simultaneous treatment with spectacles and patching has an equivalent VA outcome compared with sequential treatment, first with spectacles alone followed by patching (if needed), for previously untreated amblyopia in children 3 to \<13 years of age.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 13
You may be able to join if
- Age 3 to \<13 years at the time of randomization
- Amblyopia associated with anisometropia, strabismus, or both o Criteria for strabismic amblyopia: At least one of the following must be met:
- Presence of a heterotropia on examination at distance or near fixation (with or without optical correction)
- Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia)
- Criteria for anisometropia: At least one of the following criteria must be met:
You likely can't join if
- Myopia greater than -6.00 D spherical equivalent in either eye.
- Previous intraocular or refractive surgery.
- Planned strabismus surgery in the next 56 weeks.
- Any previous treatment for amblyopia (patching, atropine, Bangerter filter, vision therapy, or binocular treatment).
- Previous spectacle or contact lens wear for more than 24 hours.
- Parent and participant willing to forego option of contact lens wear for the duration of the study.
See the full eligibility criteria
Who can join
- Age 3 to \<13 years at the time of randomization
- Amblyopia associated with anisometropia, strabismus, or both o Criteria for strabismic amblyopia: At least one of the following must be met:
- Presence of a heterotropia on examination at distance or near fixation (with or without optical correction)
- Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia)
- Criteria for anisometropia: At least one of the following criteria must be met:
- 1.00 D difference between eyes in spherical equivalent (SE)
- 1.50 D difference in astigmatism between corresponding meridians in the two eyes
- Criteria for combined-mechanism amblyopia: Both of the following criteria must be met:
- Criteria for strabismus are met (see above)
- 1.00 D difference between eyes in spherical equivalent OR ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes
- No previous treatment for amblyopia, including no more than 24 hours of spectacle wear.
- Investigator planning to initiate spectacle correction of refractive error meeting the following criteria based on a cycloplegic refraction that has been performed within 30 days:
- Full correction of anisometropia
- Full correction of astigmatism with the same axis found by the cycloplegic refraction
- Full correction of any myopia
- Hyperopia must not be under corrected by more than 1.50 D, and reduction in plus sphere must be symmetric in the two eyes.
- At enrollment, single VA measured in each eye assessed in trial frames with the spectacle correction the investigator plans to prescribe, using the investigator's routine method as follows:
- VA in the amblyopic eye 20/40 to 20/200 inclusive.
- Age-normal VA in the fellow eye:40,41
- 3 years: 0.4 logMAR (20/50) or better
- 4 years: 0.3 logMAR (20/40) or better
- 5-6 years: 0.2 logMAR (20/32) or better
- 7-12 years: 0.12 logMAR (78 letters) or better
- Interocular difference ≥ 3 logMAR lines (0.3 logMAR) or ≥ 15 letters o When participants return for the Spectacle Baseline / Randomization Visit with their new spectacles, they will need to meet the same criteria as...
- Investigator is willing to prescribe spectacle wear followed sequentially by patching or simultaneous spectacles and patching treatment per protocol.
- Parent understands the protocol and is willing to accept randomization.
- Parent has phone (or access to phone) and is willing to be contacted by Jaeb Center staff or other study staff.
- Relocation outside of area of an active PEDIG site for this study within the next 56 weeks is not anticipated.
What rules you out
- Myopia greater than -6.00 D spherical equivalent in either eye.
- Previous intraocular or refractive surgery.
- Planned strabismus surgery in the next 56 weeks.
- Any previous treatment for amblyopia (patching, atropine, Bangerter filter, vision therapy, or binocular treatment).
- Previous spectacle or contact lens wear for more than 24 hours.
- Parent and participant willing to forego option of contact lens wear for the duration of the study.
- Ocular co-morbidity that may reduce VA determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above VA criteria are met).
- Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and/or learning disabilities or attention deficit...
- Known allergy to adhesive patches.
- Known allergy to silicone.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Glendale, Arizona, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Berkeley, California, United States
- Fullerton, California, United States
- Irvine, California, United States
- Loma Linda, California, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- Pomona, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Milford, Connecticut, United States
- Fort Lauderdale, Florida, United States
- Jacksonville, Florida, United States
- Tampa, Florida, United States
- Boise, Idaho, United States
- Chicago, Illinois, United States
- Chicago Ridge, Illinois, United States
+ 40 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 13 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Glendale, Arizona, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Berkeley, California, United States; Fullerton, California, United States and 54 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.