A Randomized Trial to Evaluate Sequential vs Simultaneous Patching
ConditionAmblyopia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age3-13
SponsorJaeb Center for Health Research
About this trial
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.
Eligibility criteria
Qualifiers
Age 3 to <13 years at the time of randomization
Amblyopia associated with anisometropia, strabismus, or both
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)
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Patching
- Glasses
Treatment groups
544 Participants
are divided into 2 treatment groupsSponsors and collaborators
Jaeb Center for Health Research
Lead sponsor
National Eye Institute (NEI)
Collaborator
Pediatric Eye Disease Investigator Group
Collaborator
Source ClinicalTrials.gov