Loma Linda, CANCT04378790Now EnrollingIRB Ready

Amblyopia Clinical Trial in Loma Linda, CA

Access cutting-edge amblyopia treatment through this phase 3 clinical trial at a research site in Loma Linda. Study-provided care at no cost to qualified participants.

Sponsored by Jaeb Center for Health Research

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Expert Care in Loma Linda

Access amblyopia specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related amblyopia treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Loma Linda

    Convenient for CA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Loma Linda site if eligible
  4. 4Begin participation

About This Amblyopia Study in Loma Linda

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.

Sponsor: Jaeb Center for Health Research

Who Can Participate

Inclusion Criteria

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:
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
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 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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Loma Linda?

Yes, this clinical trial (NCT04378790) has an active research site in Loma Linda, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Amblyopia Treatment Options in Loma Linda, CA

If you're searching for amblyopia treatment options in Loma Linda, CA, this clinical trial (NCT04378790) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Loma Linda research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced amblyopia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

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