Lens useful in inhibiting the production of melatonin and lens produced thereby

A lens that transmits light expressing a transmission curve which has a low cut-in wavelength in the vicinity of 400 nm, rising gradually in terms of percentage of light transmitted, to a maximum in the vicinity of 509 nm and then descending in equal manner, in terms of wavelength and percentage of light transmitted, to a high wavelength cut-off in the vicinity of 600 nm, and method of manufacture. The overall transmission curve expresses essentially a Gaussian configuration. The transmission curve is congruent with the rod mediated portion of the electromagnetic wavelength spectrum for the human eye, also described as scotopic in character and believed to be operative in maximizing the inhibition of melatonin secretion, a substance produced by the human pineal gland.

BACKGROUND OF THE INVENTION 
1. Field of the Invention 
The device of the invention relates generally to optical devices, and more 
particularly to optical devices transmitting light having a frequency 
range of 400-600 nanometers. The methods of the invention relate to the 
use of the device in inhibiting the production of melatonin for various 
health conditions. 
2. Description of the Prior Art 
Various devices have been developed to stimulate the senses of hearing and 
sight or to stimulate and pattern brain function; particularly as an aid 
to evoke relaxation. The idea of modifying eyeglasses for therapeutic 
reasons other than the correction of vision has been created as typified 
by British Patent No. 1,142,139 issued to Luis Toha. See also "Health in 
Color Power", the story of light by Chromatadyne Corporation, Copyright 
1939. 
No device is known nor method known which is keyed to the physiological 
impact of light on the production of melatonin by the pineal gland, 
although research over the last ten to fifteen years abounds with pineal 
and light related research. One of the most exciting aspects of the 
present invention is that the therapy offers a drug free modality. 
Published medical research indicates that melatonin secretion levels of 
the pineal gland can be regulated by selectively controlling light color 
and intensity through the eye. See Cardinali, D. P., Vacas, M. I. "Pineal 
Function in Reproductive Physiology", Recent Advances in Fertility 
Research, Part A: Developments in Reproductive Endocrinology, p. 55-71 
(1982); Cardinali, D. P., Vacas, M. I., "Pineal Gland, Photoperiodic 
Responses and Puberty?, J. Endocrinology Invest., 7:157-165 (1984); Daan, 
S., Lewy, A. J., "Scheduled Exposure to Daylight: A Potential Strategy to 
Reduce `Jet Lag` Following Transmeridian Flight", Physchopharmacology 
Bulletin 20:566-568 (1984); Lewy, A. J. et. al., "Light Suppresses 
Melatonin Secretion in Humans", Science Volume 235, p. 352-354 (Jan. 16, 
1987); Lewy, A. J. et. al., "Supersensitivity to Light: Possible Trait 
Marker for Manic-Depressive Illness", American Journal of Psychiatry, 
1142:6, p.725-727 (Jun. 1985b); Lewy, A. J., et. al., "Melatonin, Light 
and Chronological Disorders", CIBA Foundation Symposium 117, p. 231-252 
(1985a); Guyton, A. C., Textbook of Medical Physiology", Sixth Edition, 
Published by W. B. Saunders Co., (1981); Reiter, R. J., "Normal Patterns 
of Melatonin Levels in the Pineal Gland and Body Fluids of Humans and 
Experimental Animals", J. Neural Transm. Suppl., 21:35-54 (1986); Lissoni, 
Paolo et al, "A Clinical Study of the Pineal Gland Activity in Oncologic 
Patients", Cancer 57:837-842 (1986); and Fevre-Montange, Michelle, et. 
al., "Effects of `Jet Lag` on Hormonal Patterns II. Adaption of Melatonin 
Circadian Periodicity", J. Clinical Endocrinol Metabolism 52:642-649 
(1981). Brainard, G. C. et. al., "Dose-Response Relationship Between Light 
Irradiance and the Suppression of Plasma Melatonin in Human Volunteers", 
Brain Research, 454:212-218 (1988); Brainard G. C., et. al., "Effect of 
Light Wavelength on the Suppression of Nocturnal Plasma Melatonin in 
Normal Volunteers", Ann. N.Y. Acad. Sci., 452:376-378 (1985). 
Melatonin is now known to have significant impact upon the human endocrine 
system. It is known as well that the primary source of melatonin is the 
pineal gland. Additionally, the human pineal gland is photosensitive and 
responds primarily to specific wavelengths of light in the visible 
spectrum. Inhibition of melatonin secretion in the human is dependent upon 
light of specific wavelength and intensity impacting the retina, and 
particularly the rods or the scotopic portion of visible light, (Lewy, et. 
al., 1985a). Light having wavelengths between 400 and 600 nanometers is 
recognized as most affecting the scotopic or rod mediated retinal response 
(Textbook of Medical Physiology, pg. 741 & FIG. 59-7, 1981) and melatonin 
is most effectively suppressed at those wavelengths peaking at 
substantially 509 nanometers, i.e., 500-520 nanometers, (Lewy, et. al., 
1985a). 
While it is well known that eyeglasses have been made which are operable to 
pass ma-y different bands of light, no eyeglasses are known which are 
limited to the 400-600 wavelength band; nor are eyeglasses known which 
have a light intensity maximizing at 509 nanometers. See 
"Spectral-Transmissive Properties and Use of Colored Eye-Protective 
Glasses" by W. W. Coblentz and R. Stair, (Jun. 1, 1938). 
SUMMARY OF THE INVENTION 
The present invention provides an optical device for transmitting light 
having wavelengths between 400-600 nanometers while blocking light of 
other frequencies for the suppression of melatonin in the therapeutic 
treatment of various health disorders. Additionally the present invention 
provides an optical device which maximizes the intensity of light 
transmitted at substantially 509 nanometers. 
The present invention also provides methods of utilizing the above optical 
devices in the treatment of amenorrhea and dysmenorrhea, the control of 
ovulation, seasonal affective disorder, jet lag, and neoplastic tumor 
growth.

DETAILED DESCRIPTION OF THE INVENTION 
The device of the present invention may take various configurations, it 
being necessary that it be placed between the eye and a source of light. 
Contemplated structures include windows, light globes, and eyeglasses. It 
is critical to the invention that the device transmit only light having 
wavelengths in the 400-600 nanometer range; blocking light of other 
frequencies. (Lewy, A. J. et al 1985a, pg. 231-252). It is also highly 
important that the maximum intensity of the light transmitted be in the 
range of 500-520 nanometers and preferably at 509 nanometers. In that 
eyeglasses are most accessible and most convenient, it is believed that 
eyeglasses having the above transmission characteristics will be the 
preferred embodiment of the present invention. The eyeglass structure is 
conventional, except for the light transmitting lenses, and may be in the 
form of traditional monocles, spectacles, or contact lenses, including 
so-called "clip-ons". 
In the simplest form, the lenses are constructed using conventional 
homogeneous clear glass or plastic materials and then treating each lens 
with a material designed to selectively control wavelengths of light 
transmitted to the retina to the lightwave range and intensity, as above 
stated. 
The above described optical device may be effectively used in the 
correction of amenorrhea. Amenorrhea is defined as absence or abnormal 
stoppage of the menses. It is known that suppression of melatonin brings 
about an increase in gonadotropin activity. A tenfold rise in gonadotropin 
activity of urinary extracts from 11 to 14 year-old girls, corresponding 
to an approximate 30% seasonal increase in daily hours of sunshine, has 
been reported (Cardinali and Vacas, 1984). A method of maximizing exposure 
to those wavelengths between 400-600 nanometers and peaking substantially 
at 509 nanometers would therefore be beneficial in the treatment of 
amenorrhea and teenage amenorrhea, in particular. The method of the 
present invention, therefore, includes the providing of light and of 
sunlight, in particular; transmitting said light through an optical device 
having a band pass of 400-600 nanometers to the eye of the patient, 
thereby blocking all other frequencies, and repeating the process on a 
daily basis until normal menses is obtained. In that maximum suppression 
of melatonin is at a peak intensity of 509 nanometers, such transmission 
of light through the optical device is highly desired. 
The above described optical device may also be used in control of the 
menstrual cycle for increased chance of conception. Ovulation, and its 
timing, is, of course, critical to conception. Serum melatonin levels play 
a special role in this process (Cardinali and Vacas, 1982,4). The most 
recent and complete study suggests that melatonin levels in the blood of 
young women with normal menstrual cycles are lowest at the time of 
ovulation, (Reiter, 1986). A method for maximizing those wavelengths of 
light to the retina that most inhibit melatonin production would be most 
helpful, therefore, in an effort to stimulate and to time ovulation. The 
method of the present invention to inhibit the production of melatonin to 
control ovulation for promoting conception therefore includes the steps of 
first determining time of ovulation within the normal menstrual cycle; 
providing light and sunlight, in particular; transmitting the light to the 
eye from the time of onset of menses to a period of from one to three days 
before a predetermined time of optimum fertility for ovulation, generally 
mid-cycle; and then transmitting light, having only wavelengths from 
400-600, to the eye for the one to three day period immediately prior to 
the predetermined optimum time for ovulation, as related to peak 
fertility. 
The device, as above described, may also be used as a method to control 
symptoms of depression, sleep disturbance, and weight gain associated with 
the disorder, commonly known as SAD, or seasonal affective disorder. 
Individuals may be categorized as "phase advanced" indicating those 
individuals having all circadian rhythms advanced, or "phase delayed" 
indicating those individuals whose rhythms are delayed. Phase advanced 
individuals typically have difficulty going to sleep but experience early 
morning awakening. Phase delayed people have great difficulty awakening in 
the early morning. After classifying the patient as either phase delayed 
or phase advanced, the individual is instructed to use the optical device, 
transmitting only those wavelengths of light between 400-600 nanometers 
and peaking at substantially 509 nanometers. Phase delayed individuals use 
the device from dawn to three hours past dawn and phase advanced 
individuals use it from three hours pre-dusk to dusk, Lewy. et al. 1985a) 
Seven to fourteen days of this regimen is considered adequate to 
therapeutically reset ones biological clock. 
Additionally, the above described device may also be used as a method to 
inhibit the growth of neoplastic tumors. Melatonin is said to stimulate 
tumor growth in the morning and inhibit tumor growth in the late 
afternoon, (Lissoni, Paolo et. al., Cancer 57, pgs. 837-842, 1986). The 
patient is instructed to use the optical device from the time of awakening 
until sunset or dusk; the cycle being repeated as necessary. The procedure 
may be changed, as necessary, to accommodate other therapies such as 
chemotherapy, which seems to diminish blood melatonin levels. 
For controlling the symptoms of jet lag, passengers are first classified as 
"phase advanced" or "phase delayed". Jet lag is intimately related to 
melatonin level, (Fevre-Montange, 1981). Passengers upsetting their 
biological clock by traveling from west to east and hence phase delayed, 
are instructed to use the optical device of the present invention for the 
period of dawn to three hours post-dawn on a daily basis, not to exceed 
eleven days. Those individuals traveling east to west and hence phase 
advanced, are instructed to use the optical device of the present 
invention for the period of three hours pre-dusk to dusk on a daily basis, 
also not to exceed eleven days. 
Lens and Process Reduction-to-Practice 
A standard and readily available CR-39 polymer lens was immersed in a 
stainless steel tank which was filled with Red Out dye using a 1:1 ratio 
with distilled water. The Red Out dye was identified in detail in the Gott 
Affidavit of the prior application filed March 25, 1991, which is 
incorporated herein by reference and was obtained from Brain Power Inc. of 
Miami, Fla. The above liquid mixture was heated to a temperature of 
approximately 98.+-.1 degrees Centigrade. The lens was then immersed in 
the dye solution for a specific period of time dependent upon the desired 
percentage of light transmission desired. The time of actual immersion in 
the dye is dependent upon the use preferred by the wearer. Those needing a 
great deal of visible light, while still wishing to shift the burden of 
retinal work from the cones to the rods for pineal melatonin inhibition, 
require a relatively light tint involving an emersion time of 2 to 5 
minutes. A two minute dying time is the standard for those in poorly 
lighted environments or those viewing computer terminals for extended 
periods of time. 
The darker scotopic tint is used primarily for those with very sensitive 
eyes and those being worn outside for driving, flying, skiing or other 
activities that require excessive exposure to bright visual light 
stimulation. The darkest lenses in terms of percentage of light 
transmitted are produced by emersion up to 120 minutes. However, the 
majority of tint is absorbed after 55-60 minutes making a standard dying 
time for a dark scotopic lens of roughly one hour. However, small 
decreases in percentage of light transmission can be achieved with dying 
times up to two hours in duration. 
The treated lens was removed from the dying tank, rinsed and dried. The 
transmission curve of the dyed lens was then determined using a 
spectrophotometer, Bausch and Lomb Model 600. Using this Bausch and Lomb 
spectrophotometer, I observed the transmission curve substantially as 
described herein and one that I sought to develop in a lens since 1986. 
This curve had an abrupt rise in transmission from a low wavelength 
cut-off in the vicinity of 400 nanometers, peaking between 500 and 510 
nanometers at which there was a maximum percentage of light transmitted of 
64%. Then, the curve abruptly falls off to a value in the vicinity of 600 
nanometers which defines the high wavelength cut-off for my scotopic lens. 
After the lenses dyed they were edged by standard edging machines well 
known in the ophthalmic industry. The lenses were then mounted in metal or 
plastic frames suitable for eyewear. 
Having thus described in detail a preferred embodiment of the present 
invention, it is to be appreciated and will be apparent to those skilled 
in the art that many physical changes could be made in the apparatus lens 
and method described herein without altering the inventive concepts and 
principles embodied therein. The present embodiments are therefore to be 
considered in all respects as illustrative and not restrictive, the scope 
of the invention being indicated by the appended claims rather than by the 
foregoing description, and all changes which come within the meaning and 
range of equivalency of the claims are therefore to be embraced therein.