Innovation and philanthropy are often a powerful combination that have helped usher new devices, drugs or surgical approaches to the forefront of medical care. This dynamic duo has proven to provide a boost to research being conducted by Omondi Nyong'o, M.D., researcher and pediatric ophthalmologist at Sutter’s Palo Alto MedicalFoundation (PAMF). Dr. Nyong'o is studying new ways to treat amblyopia (“lazy eye”)— the most common cause of vision loss in children and young adults.
"Occlusion of the good eye with an eye patch is the preferred treatment for amblyopia affecting one eye," says Dr. Nyong'o. "But studies estimate adherence to patching regimens to be no better than 50%. This ultimately limits treatment efficacy and diminishes the restoration of visual acuity. Timely management of amblyopia during early childhood is the key to preventing its blinding long-term effects. Research that expands our knowledge and offers a practical solution can help achieve this goal for children presently at risk."
Dr. Nyong'o's compassionate care and inventive spirit prompted the mother and father of one of his patients to donate startup funds to back Dr. Nyong’o’s idea: actualize a 30-year-old concept called an occlusion dose monitor (ODM) to track adherence to eye patch wear and test this approach in a pilot study.
Flash forward eight years, and Dr. Nyong'o's innovative approach and research involving ODM has attracted additional philanthropic funding, resulted in findings published earlier this year in Journal of Binocular Vision and Ocular Motility and set the stage to expand the pilot study.
The research started by aiming to perfect the first ODM, which was invented in the 1990s. "The novel ODM we developed consists of a patch worn over the eye, a sensor fixed to the temple of the glasses frame and a system that processes the sensor’s data for interpretation by an algorithm,” says Dr. Nyong’o. “This overcomes historical challenges such as the child not having to walk around with cables running from their eye down to a Walkman on their waist. In any case ‘Walkmans’ are a tad outdated! Kids are wireless these days.”
His research team and researchers at University of California, San Francisco studied the use of the novel ODM, made in conjunction with Getchell Technologies, in 13 children with amblyopia. The researchers measured the effectiveness of the novel ODM device compared to the standard eye patch. Children in the study wore the novel ODM for two weeks and their parents were asked to document patch wear in a diary.
The pilot study showed the modified patch (with novel ODM) did not reduce patients’ willingness to wear the patch compared to a standard patch. Novel ODM-recorded wear correlated with diary-recorded wear and was more reliable than diary self-reporting. As a bonus, the novel ODM also reliably recorded when the glasses were worn and was not confounded by periods of time when the glasses or patch were not on the child’s face.
Dr. Nyong’o says the novel ODM device offers two major advantages versus the standard eye patch: “For one, it will permit doctors and families to optimize return office visits so those visits have more value. This means a reduction in unnecessary hospital visits, missed school days and missed work for busy parents. Secondly, the novel ODM offers a breakthrough means for researchers to determine the true dose-response relationship between eye patching and amblyopia.”
He adds that some children have mild amblyopia, while others have severe amblyopia causing permanent blindness.
“However, sight can be gained or lost to amblyopia during a window of opportunity in early life, typically within birth to eight years of age. As such, amblyopia should be 100% curable if managed within this period,” says Dr. Nyong’o. “Yet doctors don’t currently know how much patching different depths of amblyopia require. This dearth of knowledge hinders our ability to achieve 100% amblyopia cure rates. Once the novel ODM device is studied further, we hope to finally establish standards grounded in objective knowledge of the cadence by which the developing human visual system responds to patch occlusion.”
Dr. Nyong’o estimates doctors and families can then accurately time the wear of an eye patch, which might help lead to 100% cure rates.
He remains determined and hopeful, and has recently completed a study testing the novel ODM in a follow-up phase of the initial pilot study. Ten children participated in this follow-up study by wearing the device for six weeks—a time period that more closely mirrors actual durations of patching in real life.
Dr. Nyong’o says results have been “promising” enough to warrant study in a larger patient population, and he plans to continue the research with the hope the novel ODM will soon reach the marketplace.
For children with amblyopia, this research and innovation may well be the clearest path toward fully restored vision.
Dr. Nyong’o recounts asking a 9-year-old patient what he wanted to be when he grew up. He replied, “Dr. Nyong’o, I cannot answer you because jobs of the future are not yet even imagined!”
“This child’s reply reminded me that seemingly small adjustments in the medical care of a disease like amblyopia, at an early period in life, can have enormous consequences,” says Dr. Nyong’o. “As pediatric doctors we serve to help prepare children to reach their full potential. What that potential is may be even beyond their own vivid imaginations.”
1. Fielder AR, Irwin M, Auld R, Cocker KD, Jones HS, Moseley MJ. Compliance in amblyopia therapy: objective monitoring of occlusion. Br J Ophthalmol. Jun 1995;79(6):585–589. doi: 1136/bjo.79.6.585
2. Simonsz HJ, Polling JR, Voorn R, et al. Electronic monitoring of treatment compliance in patching for amblyopia. Strabismus. 1999 Jun;7(2):113-23. doi: 10.1076/stra.188.8.131.525.
3. Scientists David Hubel and Torsten Wiesel won a Nobel prize for their discovery of the brain basis for amblyopia.