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Q. How helpful is the Light Visor
for winter blues?
A. It is now generally accepted that light therapy is a viable treatment for winter blues. Clinical trials demonstrate that the response rates to Light Visor™ light treatment are at least as good as those for other light devices. In addition, at least 95% of customers who purchased the Light Visor™ under BioBrite's 30-day money back trial period found it very helpful.
Q. What advantages does the Light Visor™ offer?
A. The Light Visor™ is a breakthrough in light use convenience and efficiency. It weighs only 5 ounces and fits comfortably on your head. Because it is powered by a rechargeable battery pack, which you can clip to your belt, the user is free to move about. The Light Visor™ delivers light from above the eyes, so it doesn't obscure vision or interfere with normal activities. It is portable and convenient for travel.
Q. How much light is optimal?
A. Because the Light Visor™ lamps are fixed close to the eyes, it is more efficient than a light box. Many people have found that 20-to-40 minutes of Light Visor™ use in the morning is ideal as a seasonal light supplement. However, there is considerable individual variation in effective light doses. The light intensity of the Light Visor™ can be adjusted up to 3000 lux to meet a wide range of needs.
Q. Can Light Visor™ light be harmful to the eyes?
A. All of the clinical trials using the Light Visor™ received Institutional Review Board approval for human subjects. Safety is a major factor in receiving such approval. Furthermore, BioBrite commissioned a "hazard analysis" conducted by independent experts. It concluded that the energy emitted by the Light Visor™ is far below the threshold limit values recommended in national standards for photobiological safety of lamps and lighting systems. To our knowledge, BioBrite is the only manufacturer of light therapy equipment that has undertaken this type of analysis. Nevertheless, anyone with a known or suspected eye disease should consult an ophthalmologist.
Q. What about full spectrum light?
A. Early researchers in light therapy thought it was necessary to use "full spectrum" light (light that imitates the color spectrum of natural sunlight, including UV). However, controlled clinical trials using white light (like that of most light bulbs) have shown that as long as the light is bright enough it can be effective. Full spectrum lights emit UV light may which can be damaging to the eyes and skin. The Light Visor™ emits white light with no UV
Q. Are side effects a problem?
A. In clinical trials, the frequency of minor side effects such as eye strain, fatigue, feeling "wire", headache and insomnia were reported as extremely low, and are quickly alleviated by reducing light intensity and/or time of use.
Q. Is the Light Visor™ covered by medical insurance?
A. Approximately 50% of those who have applied for third party coverage of therapeutic light have been successful in obtaining some amount of reimbursement. A letter from a prescribing physician or qualified therapist is generally necessary.
Q. What clinical trials have been conducted?
A. Large controlled clinical trials, involving six institutions, and more than 200 patients with SAD, were conducted over three fall/winter seasons beginning 1989. One of these trials which involved 105 patients and six institutions (National Institute of Mental Health, McLean Hospital, Harvard Medical School, University of Utah, University of British Columbia, University of Toronto) was the single largest controlled trial ever done on the use of light treatment for SAD (Joffe, R., et. al., Psych Research, 1993, 46:29-39). Results of another trial involving 55 patients have also been published. (Rosenthal, N.E., et. al.,Neuropsychopharmacology, 1993, Vol 8, No. 2). Clinical efficacy was demonstrated in all three trials.
The BioBrite Light Visor™ is the result of scientific study focused on developing a mobile light source capable of delivering light therapy without severely restricting movement or limiting activities of patients receiving the therapy. The first light therapy devices were light boxes. Early models were large, heavy , and awkward to move around. Current models have been greatly refined and are much easier to transport; however, these devices necessarily confine the patient to remaining in front of stationary boxes while receiving light therapy. The restrictive nature of light boxes and their concomitant effects on patients' quality of life led pioneering scientists in the field, including Dr. George Brainard of the Thomas Jefferson University College of Medicine, and Drs. Norman Rosenthal and Thomas Wehr of the National Institutes of Health, to experiment with head-mounted, battery- operated units capable of shining bright light into patients' eyes without requiring the recipients to remain immobile. BioBrite worked with these investigators to develop and market a lightweight, easy to use, mobile head-mounted device, now trade-marked as the BioBrite Light Visor™ . The Light Visor™ has been tested in controlled clinical trials. The earliest, in 1992, was in fact the largest single trial conducted in one season on the use of light to treat SAD (Joffe, R.T., et. al.; Psychiatry Research , 46, 1993). There were more than 100 patients involved. The response rate was good, comparable to light boxes, however, some patients responded to low Visor light intensities, raising the placebo issue. In retrospect, based on current knowledge of the biological effects of light on humans, a feasible argument can be made that under the circumstances of the experimental design, low intensity light might have been effective for some people. Nevertheless, a recent review of published data from light box trials and head mounted units (HMUs) trials by two authoritative clinicians led them to conclude that HMUs produce response rates similar to light boxes for SAD (Seasonal Affective Disorder and Beyond: Light Treatment for SAD and Non-SAD Conditions . Ed. Lam, R. W., American Psychiatric Press, Inc, Washington, DC, 1998). In evaluating clinical results of Visor trials, some investigators have ignored, or are not aware, that four different models of the Light Visor™ have been marketed by BioBrite. Each model incorporates improvements over earlier models. Therefore, data from the first prototype model cannot fairly be compared with data from more current models. Design problems with the Light Visor™ principally relate to filling the field of vision of users with light, yet not obstructing vision. This is a considerable challenge, considering anatomical differences of human heads. The design of the relatively new LED model has significantly addressed this problem. The light bar is located further forward, directing light to the eyes at less of an angle, and an array of LEDs provides a much larger area of light to the eyes. Dr. George Brainard, Jefferson Medical College, an acclaimed expert on the biological effects of light in humans, and Dr. Brenda Byrne, a clinical expert on SAD, at the same institution, have conducted controlled clinical trials to measure the effect of the LED model Light Visor™ on melatonin ("the light hormone") suppression in normal human volunteers.
The data was presented at the 1999 annual meeting of the Society for Light Treatment and Biological Rhythms (SLTBR) and clearly demonstrated that LED Visor light can significantly suppress melatonin, an important marker for the biological activity of light. Later, prominent clinical investigators at Yale Medical School and Jefferson Medical College, conducted an open trial of the LED Light Visor™ in SAD patients. All of the 10 patients who completed the study responded very well, and were pleased with the Visor. These results were reported at the 2000 annual meeting of the SLTBR, and can be found in the published abstracts, Vol. 12, of the society.
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