A Randomized Trial to Evaluate Sequential vs Simultaneous Patching

  • STATUS
    Recruiting
  • End date
    Sep 20, 2022
  • participants needed
    544
  • sponsor
    Jaeb Center for Health Research
Updated on 24 October 2021

Summary

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.

Description

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.

Details
Condition Amblyopia
Treatment Patching, Glasses
Clinical Study IdentifierNCT04378790
SponsorJaeb Center for Health Research
Last Modified on24 October 2021

Eligibility

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
met
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
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
years: 0.4 logMAR (20/50) or better
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
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 10 minutes (based upon the mean of a test and retest of VA in those new spectacles)
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

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
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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.

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