A Randomized Trial to Evaluate Sequential vs Simultaneous Patching (ATS22)

  • End date
    Jun 15, 2023
  • participants needed
  • sponsor
    Jaeb Center for Health Research
Updated on 7 October 2022
Raymond Kraker, MSPH
Primary Contact
PineCone Vision Center (7.6 mi away) Contact
+51 other location


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.


At an enrollment visit, distance VA will be measured in trial frames with or without cycloplegia based on a cycloplegic refraction performed within 30 days. If still apparently eligible, children will be prescribed spectacles and will then return for a spectacle baseline visit, where they will wear their new spectacles for the first time for at least 10 minutes (but no more than 24 hours) and will be tested in those new spectacles to confirm final eligibility prior to randomization.

Participants not found to be eligible in their new spectacles will end study participation. Participants eligible for the study will be randomly allocated to one of two treatment groups: Sequential (spectacles alone) and then patching if needed (monitored by ODM), or Simultaneous (spectacles and patching monitored by ODM).

After randomization, follow-up visits will occur at 8-week intervals through 56 weeks. At each visit on or after the 8-week visit, participants will be classified as either: stable/worsening or improving; those stable/worsening are then classified as having either resolved or residual amblyopia, provided that the current and most recent previous visit were completed at least 6-weeks apart (target 8 weeks) and provided the required test and retest VA testing was completed. Participants who are stable/worsening and have residual amblyopia in the sequential group will start patching (monitored by ODM) and continue to be followed every 8 weeks. Participants in the simultaneous group, or in the sequential group after having advanced to patching, who are stable/worsening but have residual amblyopia will be released to treatment at investigator discretion.

All participants continue 8-weekly visits until 56 weeks when Study participation ends.

Condition Amblyopia
Treatment Patching, Glasses
Clinical Study IdentifierNCT04378790
SponsorJaeb Center for Health Research
Last Modified on7 October 2022


Yes No Not Sure

Inclusion Criteria

Age 3 to <13 years at the time of randomization
Amblyopia associated with anisometropia, strabismus, or both
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
00 D difference between eyes in spherical equivalent (SE)
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)
00 D difference between eyes in spherical equivalent OR ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes
Investigator planning to initiate spectacle correction of refractive error meeting the following criteria based on a cycloplegic refraction that has been performed within 30
No previous treatment for amblyopia, including no more than 24 hours of spectacle
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
VA in the amblyopic eye 20/40 to 20/200 inclusive
At enrollment, single VA measured in each eye assessed in trial frames with the
Age-normal VA in the fellow eye:40,41
spectacle correction the investigator plans to prescribe, using the
years: 0.4 logMAR (20/50) or better
investigator's routine method as follows
years: 0.3 logMAR (20/40) or better
-6 years: 0.2 logMAR (20/32) or better
-12 years: 0.12 logMAR (78 letters) or better
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
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 above using
the ATS-HOTV or E-ETDRS protocol after wearing the new spectacles for at least
minutes (based upon the mean of a test and retest of VA in those new
Investigator is willing to prescribe spectacle wear followed sequentially by patching
or simultaneous spectacles and patching treatment per protocol

Exclusion Criteria

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 hyperactivity disorder (ADHD) are not excluded
Known allergy to adhesive patches
Known allergy to silicone
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note