WO2013050735A1

WO2013050735A1 - Spectacles

Info

Publication number: WO2013050735A1
Application number: PCT/GB2012/052329
Authority: WO
Inventors: Irene Veronika CONSTANTINESCU-GOTTLOB; Frank Antony PROUDLOCK; Glenford Percival Charles BUSH
Original assignee: University Of Leicester
Priority date: 2011-10-03
Filing date: 2012-09-20
Publication date: 2013-04-11
Also published as: GB2495697B; GB2495697A; GB201116997D0

Abstract

The present invention relates to spectacles, and to uses thereof for treating a wide range of eye and visual disorders, such as myopia, hyperopia, astigmatism or amblyopia etc.

Description

SPECTACLES

The present invention relates to spectacles, and to uses thereof for treating a wide range of eye and visual disorders, such as myopia, hyperopia, astigmatism or amblyopia etc. Myopia or "shortsightedness" is a condition of the eye where the light that comes in does not directly focus on the retina, which is in the back of the eye. Because of this, the image that one sees is out of focus when looking at a distant object but comes into focus when looking at a close object. Hyperopia or "longsightedness", on the other hand, is a defect of vision caused by an imperfection in the eye (often when the eyeball is too short or the lens cannot become round enough), causing difficulty when focusing on near objects, and in extreme cases causing a sufferer to be unable to focus on objects at any distance. Astigmatism is an optical defect in which vision is blurred due to the inability of the optics of the eye to focus a point object into a sharp focused image on the retina, which may be because of an irregular or toric curvature of the cornea or lens.

Amblyopia, otherwise known as lazy eye, is a disorder of the visual system that is characterized by poor vision or lack of vision in an eye that is otherwise physically normal. The problematic eye is typically healthy but, due to development issues, the visual information received at the back of the eye and the neural information interpreted by the brain is not well transmitted or recognized. Amblyopia affects approximately 2% to 5% of children. Amblyopia can be treated using an occlusive eye patch in a technique known as "patching", which accounts for approximately 90% of work in childrens' eye clinics. Results have also shown that the duration of treatment of amblyopia is long, expensive, with poor outcomes, and may not reach the accepted level of vision at discharge. Hence, the resultant outcome of ineffective treatment is residually amblyopic children who remain residual amblyopic adults with a reduced quality of life.

Myopia, hyperopia, astigmatism and amblyopia, as well as many other visual disorders, can be treated by the use of spectacles or "glasses", which can be worn by both adults and children. However, the problem with spectacles is that although it is assumed that the subject is wearing them, in reality, some subjects, especially children, do not wear the spectacles at all, while others wear them, but possibly only for short periods during the day and/or at the wrong times. Therefore, the use of spectacles for treating visual defects in children in particular fails in many cases mainly due to the lack of cooperation from the child to undertake the continual treatment that is needed. Other problems associated with wearing spectacles include victimisation, poor cosmetic appearance of the spectacles, discomfort during treatment and a lack of confidence caused through treatment. There is therefore a need to provide devices and methods which can be used for determining whether or not a subject (and especially a child) is actually wearing their spectacles. Determining the level of a subject's compliance to wearing their spectacles over a period of time would assist in the treatment of a wide range of ocular diseases and visual defects, such as amblyopia, myopia and hyperopia.

Thus, according to a first aspect of the invention, there are provided spectacles comprising a sensor, which is arranged, in use, to detect when the spectacles are being worn by a subject. Referring to Figure 4, there is shown the data generated from the inventors' own pilot study in which they demonstrated, for the first time ever in children with amblyopia, that there is a proportional relationship between the length of time that a subject wears their spectacles and the percentage improvement in their vision. Indeed, wearing spectacles for approximately 12 hours a day resulted in a 60% improvement in vision compared to subjects who did not wear glasses, and the direct linearity of the response shown, in Figure 4, was unexpected. . The inventors were very surprised to observe such a strong correlation between the improvement in vision and the amount of spectacles wearing. The data demonstrates that wearing spectacles is a significant part of treatment of visual defects (for example amblyopia) in addition towearing an occlusive eye patch, and signifies a clear change in therapies that should be used in future

Advantageously, since compliance to wearing spectacles is one of the main hindrances to successful treatment of many visual or ocular defects, such as amblyopia, the spectacles of the first aspect will have significant applications in a clinical setting by informing clinicians about the compliance of their patients.

The sensor may be integrated inside the frame of the spectacles. Alternatively, the sensor may be attached to the frame of the spectacles, and preferably an arm of the frame of the spectacles. The sensor may be located (either in or on the frame) at a position which, when worn by the subject, corresponds to the bridge of the subject's nose. Preferably, however, the sensor may be located at a position which, when worn by the subject, corresponds to a side of the subject's head, and preferably at least adjacent the subject's temple. The inventors have found that placing the sensor on the side of the spectacles improves wearability, and decreases the chance that the subject may be embarrassed to wear them. It is makes the spectacles more comfortable to wear and does not restrict vision. Furthermore, by placing the sensor at least adjacent the subject's temple improves the sensitivity of detection of when the spectacles are being worn. The sensor may be capable of generating a first signal when the spectacles are being worn. The sensor may be capable of generating a second signal when the spectacles are not being worn. The sensor may comprise processing means arranged to receive the first and/or second signal, and thereby determine when the spectacles are being worn. The sensor may comprise a timer coupled to the processing means for generating a time signal.

In one embodiment, the sensor may comprise temperature sensing means, which is arranged, in use, to detect the temperature of the subject's head, preferably at least adjacent the subject's temple. Thus, the first signal may correspond to the temperature of the subject's head. The second signal may correspond to the temperature away from the subject's head, which may be room temperature. Thus, it will be appreciated that the sensor is adapted to detect a temperature differential created between the two temperatures. In a second embodiment, the sensor may comprise contact sensing means, which is arranged, in use, to detect when the spectacles are positioned at least adjacent the subject's head, preferably at least adjacent the subject's temple. The contact sensing means may comprise a contact-sensitive switch that is in a closed configuration when placed in contact with the subject, and in an open configuration when not in contact with the subject. Thus, the first signal may correspond to the closed configuration of the switch, and the second signal may correspond to the open configuration of the switch. The contact sensing means may comprise a touch-sensitive screen.

In a third embodiment, the sensor may comprise proximity sensing means, which is arranged, in use, to detect when the spectacles are positioned at least adjacent the subject's head, preferably at least adjacent the subject's temple. The proximity sensing means does not require contact with the subject in order to generate a signal.

The sensor may comprise at least one printed circuit board (PCB), and preferably two printed circuit boards, as shown in Figure 2. Preferably, first and second PCBs may comprise mutually engaging attachment means, which allow the two PCBs to be joined together. The two PCBs may sandwich the frame of the spectacles, with the first PCB being disposed on one side of the frame and contacting the subject, when in use, and the second PCB being disposed on the opposite side of the frame, and not in contact with the subject, when in use. Preferably, in use, the first PCB is disposed on one side of the arm of the spectacles contacting the skin near the subject's temple, and the second PCB is disposed on the opposite side of the arm of the spectacles, and not in contact with the skin near the subject's temple. The sensor may comprise memory (for example, a memory chip) on which data corresponding to the first and/or second signal may be stored. The sensor may comprise means by which data may be transferred from the memory, and allowing for a connection to a computer. For example, the sensor may comprise a transmitter for transmitting output data from the sensor, either continuously or intermittently. In this embodiment, a receiver may be used to receive the transmitted data, for processing by the processing means.

The sensor may comprise a power source, for example a battery. The sensor is preferably capable of continuously detecting whether or not the spectacles are being worn by the subject for at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 or 21 days or more. The subject may wear the spectacles for one, two, three or four months.

According to a second aspect, there are provided spectacles according to the first aspect, for use in therapy.

According to a third aspect, there are provided spectacles according to the first aspect, for use in treating an eye disorder or defect. For example, the eye disorder or defect may be myopia, hyperopia, astigmatism or amblyopia. It will be appreciated that myopia and hyperopia are types of refractive error. Thus, the spectacles may be used for treating an eye disorder characterized by a refractive disorder. The spectacles are preferably used for treating amblyopia. The spectacles may be worn in combination with other treatments for eye disorders, such as an occlusion eye patch, which is commonly used for treating amblyopia.

According to a fourth aspect, there is provided a method of treating an eye disorder or defect in a subject, the method comprising attaching, to a subject in need of such treatment, spectacles according to the first aspect. According to a fifth aspect, there is provided a method of monitoring a subject wearing spectacles, the method comprising attaching, to the subject, spectacles according to the first aspect.

The methods may comprise the subject wearing the spectacles for at least one day. Preferably, the subject wears the spectacles for at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 or 21 days or more. The subject may even wear the spectacles for one, two, three or four months. Following the period during which wearing the spectacles has been monitored, the method may comprise downloading the data stored in the memory which corresponds to the first and/or second signal. The clinician may then assess when, and for how long, the subject has been wearing the spectacles. Thus, the methods determine patient compliance in wearing the spectacles.

All of the features described herein (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined with any of the above aspects in any combination, except combinations where at least some of such features and/or steps are mutually exclusive.

Embodiments of the invention will now be further described, by way of example only, with reference to the following Examples, and to the accompanying diagrammatic drawings, in which:-

Figure 1 shows a child wearing one embodiment of a pair of spectacles fitted with a dose monitor according to the invention;

Figure 2 shows an enlarged view of various components of the dose monitor shown in Figure 1;

Figure 3 is a graph illustrating an example of data recorded by the dose monitor. The x- axis represents time (days) and the y-axis represents temperature difference (°C); and Figure 4 is a graph showing the improvement in vision during an 18 week pilot study in which a subject wore spectacles in relation to dose.

Example

Referring to Figure 1, there is shown a subject 2 (e.g. a child) wearing a pair of glasses (also known as spectacles) 4 having two lenses 6 and arms 8. Glasses or spectacles wearing is usually prescribed to treat children suffering from various eye and visual disorders, such as short-sightedness, long-sightedness or amblyopia. A first

embodiment of a dose monitor 10 is attached to one of the arms 8 of the spectacles 4, by which it is possible to monitor when, and to what extent the subject 2 wears the spectacles 4. For example, the subject 2 can be monitored over a set period of time, for example at least a week. The dose monitor 10 monitors compliance of the subject 2 to wearing the spectacles 4 by detecting and recording the temperature difference between two surfaces.

Referring to Figure 2, there are shown the major components of the dose monitor 10. The monitor 10 essentially consists of first and second printed circuit boards (PCB) 12, 14, which are powered by a coin cell battery 20 of voltage 3V. The PCBs 12, 14 are attached together by mutually engaging attachment means 16,18 such that they sandwich one arm 8 of the pair of spectacles 4, with the first PCB 12 being disposed on one side of the arm 8 contacting the skin near the subject's temple, and the second PCB 14 being disposed on the opposite side of the arm 8, and not in contact with the subject's temple. The mutual positioning of the PCBs 12, 14 is such that a temperature differential is created between the two surfaces, with the PCB 12 contacting the subject's temple being at a higher temperature than the other PCB 14.

The dose monitor 10 detects the temperature difference between the two flat surfaces of the PCBs 12,14 by means of two digital temperature sensors 22, 24, one being provided in each PCB 12,14. These sensors can allow wireless monitoring of temperature (i.e. without batteries), for example the TSE AS10 wireless SAW temperature sensor (Senseor,

France). Temperature measurements are made at five minute intervals for a minimum period of 21 days, and the data is stored on an Electronically Erasable Programmable Read-Only Memory (EEPROM) chip 26, which connected to one of the PCBs 12,14. In order to initiate the dose monitor 10, before a subject 2 is tested, it is first connected to a computer (not shown). The subject 2 then wears the spectacles 4 for the 21 day period during which temperature measurements are taken. After the measurements have been taken, the monitor 10 is again connected to the computer in order to download the data from the memory chip 26.

Referring to Figure 3 there is shown an example of a partial data recording derived from the spectacles monitor 10 as a time trace, with time on the x-axis (in days) and difference in temperature (in °C) on the y-axis. The recording shows data over a 21 day period. Spectacles 4 wearing is determined as a deviation from the baseline 28 (i.e. near o° on the y-axis). When the spectacles 4 are being worn, there is a greater temperature difference between the two surfaces of the monitor 10, which appear on the trace as a deflection or peak 30 away from zero (approximately 1 degree difference). The temperature difference between the two surfaces also fluctuates, leading to a spiky appearance of the trace during glasses 4 wearing.

Referring to Figure 4, there is shown data generated from the inventors' own pilot study in which they demonstrated, for the first time, that improvement in vision in a subject 2 is strongly correlated to the amount of the spectacles 4 wearing. Indeed, the graph shows that there is a proportional relationship between the length of time that a subject 2 wears their spectacles and the percentage improvement in their vision. In a second embodiment, the dose monitor 10 includes a contact sensor (not shown) or proximity sensor (not shown) instead of temperature sensors 22, 24. The contact sensor includes a contact-sensitive switch that is in a closed configuration when placed in contact with the subject 2, and in an open configuration when not in contact with the subject 2. When the spectacles 4 are worn by the subject 2, the switch is urged to contact the subject's 2 temple, and closes such that a first signal is generated. However, when the spectacles 4 are taken off, the switch is open, thereby generating a second signal. The proximity sensor is capable of detecting where the spectacles 4 are close to the subject 2, but without the need for any physical contact. In a third embodiment (not shown), the dose monitor 10 is incorporated inside the arm 8 of the spectacles 4 rather than being attached to the outside of the arm 8. It is envisaged that the spectacles 4 having the dose monitor 10 can be used in combination with other methods, which monitor the amount of patching of the eye by a subject 2, since patching is often used in combination with spectacles wearing to treat amblyopia. Advantages of the spectacles 4 and dose monitor 10 of the invention reside in the efficient manner by which it can be used to monitor the frequency and duration that a subject 2 wears their spectacles 4. The monitor 10 is, in effect, a way of policing whether or not a subject 2 wears their spectacles 4.

Claims

1. Spectacles comprising a sensor, which is arranged, in use, to detect when the spectacles are being worn by a subject.

2. Spectacles according to claim l, wherein the sensor is integrated inside the frame of the spectacles.

3. Spectacles according to claim 1, wherein the sensor is attached to the frame of the spectacles, preferably an arm of the frame of the spectacles.

4. Spectacles according to claim 1, wherein the sensor is located at a position which, when worn by the subject, corresponds to a side of the subject's head.

5. Spectacles according to claim 4, wherein the sensor is located at a position which, when worn by the subject, corresponds to at least adjacent the subject's temple.

6. Spectacles according to any preceding claim, wherein the sensor is capable of generating a first signal when the spectacles are being worn.

7. Spectacles according to claim 6, wherein the sensor is capable of generating a second signal when the spectacles are not being worn.

8. Spectacles according to claim 7, wherein the sensor comprises processing means arranged to receive the first and/or second signal, and thereby determine when the spectacles are being worn.

9. Spectacles according to claim 8, wherein the sensor comprises a timer coupled to the processing means for generating a time signal.

10. Spectacles according to any preceding claim, wherein the sensor comprises temperature sensing means, which is arranged, in use, to detect the temperature of the subject's head, preferably at least adjacent the subject's temple.

11. Spectacles according to claim 10, when dependent on claim 7, wherein the first signal corresponds to the temperature of the subject's head, and the second signal corresponds to the temperature away from the subject's head, which may be room temperature.

12. Spectacles according to any one of claims l-io, wherein the sensor comprises contact sensing means, which is arranged, in use, to detect when the spectacles are positioned at least adjacent the subject's head, preferably at least adjacent the subject's temple.

13. Spectacles according to claim 12, wherein the contact sensing means comprises a contact-sensitive switch that is in a closed configuration when placed in contact with the subject, and in an open configuration when not in contact with the subject.

14. Spectacles according to claim 13, when dependent on claim 7, wherein the first signal corresponds to the closed configuration of the switch, and the second signal corresponds to the open configuration of the switch.

15. Spectacles according to any preceding claim, wherein the sensor comprises proximity sensing means, which is arranged, in use, to detect when the spectacles are positioned at least adjacent the subject's head, preferably at least adjacent the subject's temple.

16. Spectacles according to claim 7, wherein the sensor comprises memory on which data corresponding to the first and/or second signal is stored.

17. Spectacles according to claim 16, wherein the sensor comprises means by which data is transferred from the memory, and allowing for a connection to a computer.

18. Spectacles according to any preceding claim, wherein the sensor comprises a transmitter for transmitting output data from the sensor, either continuously or intermittently.

19. Spectacles according to claim 18, wherein a receiver is used to receive the transmitted data, for processing by the processing means.

20. Spectacles according to any preceding claim, wherein the sensor comprises a power source, for example a battery.

21. Spectacles according to any preceding claim, wherein the sensor is capable of continuously detecting whether or not the spectacles are being worn by the subject for at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 or 21 days, or more.

22. Spectacles according to any one of claims 1-21, for use in therapy.

23. Spectacles according to any one of claims 1-21, for use in treating an eye disorder or defect.

24. Spectacles according to claim 23, wherein the spectacles are used for treating an eye disorder or defect characterized by a refractive disorder.

25. Spectacles according to either claim 23 or 24, wherein the eye disorder or defect is myopia, hyperopia, astigmatism or amblyopia.

26. Spectacles according to claim 25, wherein the eye disorder or defect is amblyopia.

27. Spectacles according to any one of claims 23-26, wherein the spectacles are worn in combination with an occlusion eye patch.

28. A method of monitoring a subject wearing spectacles, the method comprising attaching, to the subject, spectacles according to any one of claims 1-21.

29. A method of treating an eye disorder or defect in a subject, the method comprising attaching, to a subject in need of such treatment, spectacles according to any one of claims 1-21.