Research Studies

PEDIG Amblyopia Treatment Study

New Amblyopia Study at Berkeley Optometry is recruiting for patients!

Amblyopia is the most common cause of monocular visual impairment in children. The choice of a sequential approach versus a simultaneous approach to “optical treatment (glasses) plus patching treatment” remains unresolved, with some existing data supporting one approach and some data supporting the other. This unresolved controversy results in a dichotomy of current clinical practice, with some care providers favoring one approach and others favoring the opposite approach. In addition, the influence of adherence to patching on treatment response is not well understood.

The Pediatric Eye Disease Investigator Group (PEDIG) is conducting a clinical trial to evaluate if treating amblyopia with glasses and patching at the same time improves vision as well as treating amblyopia first with glasses and then with patching, if needed. This study will also use occlusion dose monitors (ODMs) to record adherence with prescribed patching treatment, to study dose-response. The study is supported through funding from the National Eye Institute of the U.S. National Institutes of Health.

Study Specifics:

• 544 children are expected to be enrolled

• Children must be between 3 to < 13 years old

• Visual acuity in the amblyopic eye must be between 20/40 and 20/200

• Random assignment to either:

  • Sequential treatment: full-time glasses first, with subsequent patching for 2 hours per day/7 days per week if there is no further improvement in amblyopic eye visual acuity with glasses alone and there is residual amblyopia, OR

  • Simultaneous treatment: full-time glasses and part-time patching for 2 hours per day/7 days per week

• Follow-up visits every 8 weeks for 56 weeks

• The parent of the participant will be compensated $40 for each completed visit (up to $400). Spectacles are covered

• No previous treatment for amblyopia is allowed, including glasses or contact lenses.

• See Parent Brochure and Flyer

Contact: jenhfisher@berkeley.edu or UCBpedig@gmail.com

CHAPERONE STUDY

UC Berkeley is the newest active site in the CHAPERONE Study. This is an industry-sponsored, multi-center, participant and investigator-masked, 3-arm randomized controlled trial testing the safety and efficacy of a microdose of 0.01% atropine sulfate and 0.1% atropine sulfate against a placebo (vehicle) control.

Study Information:

Duration: 48 months (4 years). Subjects will spend 36 months on one of three possible treatments (0.01% atropine, 0.1% atropine, or vehicle control), then they are re-randomized to another treatment in the final year. Those who were on placebo for the first three years are guaranteed to be placed in a treatment arm for the final year of the study. Participants are asked to return to the clinic every 6 months during the study.

Randomization: Participants are randomized into one of the three arms, placebo, 0.01% atropine and 0.1% atropine in a 1:1:1 ratio.

Eligibility: We are looking to recruit subjects in the age range of 6-12 years of age (although participants over the age of 3 are permitted as long as they are able to cooperate fully for the required study testing).

Inclusion Criteria:

• Myopia between -0.50D and -6.00D (SER) in both eyes

• Astigmatism less than or equal to 1.50DC

• Anisometropia less than 1.50D

Exclusion Criteria:

• Any current (or any history of) amblyopia or strabismus

• History of any disease or syndrome that predisposes the participant to high myopia (e.g. Stickler Syndrome, ROP)

• Any abnormal ocular refractive anatomy (e.g. keratoconus)

• Any serious systemic illness

• Chronic use (defined as more than three times per week) of any topical ophthalmic drug other than the study medication.

• Any current (or history of) myopia control treatment (e.g. orthokeratology, multifocal lenses, atropine, bifocal spectacle lenses). Single vision soft contact lenses and single vision spectacle lenses are the only acceptable forms of refractive correction for the duration of the trial.

Benefits: The greatest benefit to participants is being able to assist in our understanding of myopia management and influence the future of pediatric eye care. To show our appreciation for participating in this important research, all study-related eye care visits will be paid for by the sponsor, and participants will also receive an annual reimbursement for glasses or contact lenses, as well as a few age-appropriate gifts throughout the trial period.

How to Enroll:

If you have a patient that you would like to refer, please have them contact our study team at chaperone.berkeley@gmail.com

CHILDHOOD ACTIVITY AND MYOPIA (CAM) STUDY

The CAM Study is investigating the role of kids' indoor and outdoor behaviors and their need for glasses through the use of wearable technologies. This study is actively recruiting and being conducted at UC Berkeley & UCSF.

Study Specifics:

• Recruiting kids aged 6-10 year old

• Total of 4 visits that will last approximately 30-60 minutes each

• First 2 visits are separated by about 2 weeks

  • During the 2 week study period, your child will be asked to wear a watch and bike helmet device in their typical indoor and outdoor environments.

• Return for follow up after six months to complete the last 2 visits

  • The patient repeats the same tasks again for another two weeks

• Patient can be on myopia control treatment and still participate

The parent of the patient will be reimbursed for your time and travel. Your child will receive a small gift.

Please contact us at thecamstudy@gmail.com for more information and to sign up.