Irlen syndrome: expensive lenses for this ill defined syndrome exploit patients
BMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g4872 (Published 29 July 2014) Cite this as: BMJ 2014;349:g4872
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Philip Griffiths is right to point out that interpretation of the results of our double-masked study is compromised by the high rate of attrition. I made mention of this in my first response and alluded to such criticism in my second. It should be borne in mind that this study was conducted 20 years ago before the CONSORT guidelines were first published.
It is perhaps unwise to conclude that “the study can only be taken as evidence that precision tinted lenses do not improve real world reading in subjects with reading difficulties”. First, in this study at least, the population was not selected on the basis of reading difficulty; second, the lenses optimally tinted and those suboptimally tinted, used a control, both improved reading rate compared with baseline; third, if the study is indeed compromised by attrition, so are all the inferences that can be made from it, both positive and negative.
It is important to remember that a scientific study, no matter how good, cannot demonstrate the absence of an effect; it can, however, fail to demonstrate the presence of an effect, which is not the same thing. In this instance, our failure to show an effect of tints on reading speed was most probably due to the variability in measurement of reading rate introduced by comprehension of the text. Subsequent work over the ensuing years has developed alternative measures of reading rate that avoid this source of variability and are clearly sensitive to visual factors, including font design, prismatic correction, and, yes, coloured filters.
Although the precision tints may help with the poorly defined syndrome identified by Meares and Irlen, there is little point in comparing a rose tint with Irlen filters, as suggested by Sam Lewis, partly because the Irlen lenses have not been described in a scientific publication and the rationale behind their design is unclear, and partly because there is evidence that a one-size-fits-all rose colour is not generally beneficial.
In my view, the burden of evidence of benefit from precision tints is sufficient to justify a properly designed fully funded clinical trial, but if public money is to be spent on such a trial it might be best to begin with an investigation of photophobia in migraine, a relatively well-defined condition which is common, disabling and has a considerable economic burden. The need for a trial of precision tints in migraine prophylaxis is indicated by (1) anecdotal evidence of patients whose migraine headaches have been reduced by precision tints; (2) two studies that show, in the visual cortex of patients with migraine, an abnormal haemodynamic response to visual stimuli, a normalisation of this response when precision tints are worn, and no such normalisation with control tints; (3) a small-scale randomised control trial of precision tints in migraine with weak but positive outcome; (4) reports from optometrists that their patients have reported they can prevent or abort their migraine aura by wearing precision tints.
Over five of the last 20 years I have tried repeatedly to get such a study under way, but my applications for funding have not met with success.
Competing interests: I receive an Award to Inventors from the Medical Research Council based on a proportion of royalties on sales of the Intuitive Colorimeter.
In response to Arnold Wilkins contribution of 11th August, it is important to remember that the randomised placebo controlled trial of which he was an author showed no statistically significant difference in reading speed, accuracy or comprehension between placebo lens and experimental lens(1).
The part of the trial looking at relief of symptoms was seriously undermined by missing data. Of 68 children enrolled into the study only 36 kept symptoms diaries. However, the data was not analysed on an intention to treat basis and no attempt was made to account for the missing data in accordance with CONSORT guidelines for reporting clinical trials. It is incorrect to describe a trial with this level of dropout, randomised. Although allocation at entry may be random, drop-outs usually are not.
One of his co-authors has acknowledged that this was really a pilot study, yet it is cited as definitive evidence for the use of colour and in the 20 years that have elapsed a better study has yet to appear. This study can only be taken as evidence that precision tinted lenses do not improve real world reading in subjects with reading difficulties.
1. Wilkins AJ, Evans BJ, Brown JA, Busby AE, Wingfield AE, Jeanes RJ, et al. Double-masked placebo-controlled trial of precision spectral filters in children who use coloured overlays. Ophthalmic Physiol Opt J Br Coll Ophthalmic Opt Optom. 1994 Oct;14(4):365–70.
Competing interests: No competing interests
In his “Author’s Response” of 30th July 2014 modified by The BMJ on 4 August 2014, Mr Gwyn S Williams says:
“This was highlighted by two randomised placebo controlled trials of coloured lenses which demonstrated improvement in all groups but with the greatest improvement, interestingly, in the control/sham groups6,7.”
As one of the authors of the randomised controlled trial numbered 7 in the above quotation, I should point out that the results were not as Mr Williams quotes them, but rather the reverse. He should look again at Figure 2. The symptoms were greatest in the control, not the active group. The study may be criticised on other grounds, but surely not by quoting the reverse of the results that we in fact obtained. In any event, the results of this trial relate to tints prescribed from the Intuitive Colorimeter system, and not those provided by Irlen.
Competing interests: I receive an "Award to Inventors" from the Medical Research Council based upon a proportion of sales of the Intuitive Colorimeter.
We have now been examining both children and adults with dyslexia primarily, but also some with photo sensitive migraines, now for sixteen years.
Over that period of time according to our records we have examined more than a thousand patients. Many of these patients have seen a significant increase in reading speed using tinted lenses and have also found reading to be significantly more comfortable with their specific tinted lenses.
A full binocular vision assessment is undertaken. Steps are taken to reduce the potential for placebo/novelty effects, for example unless testing suggests a very large effect and patients express a preference for spectacles, children are encouraged to use overlays for some time to ensure that benefit is sustained, before considering the purchase of spectacles.
An example of one of our patients is a lady in her early forties whom is completing a post graduate degree. She has been using her rose-tinted lenses now for over two years and finds that her reading is "unbelievably more comfortable" with the spectacles on than without. She also has a distance pair with the specific tint on to alleviate her migraine problems (details changed to prevent inadvertant identification).
Whilst I realise that there are some authors who have suggested that on the effect of specific tinted lenses in both the fields of migraine and dyslexia is due to the placebo , I have no doubt what so ever from my practical experience that the right colour for the right patient can have a huge impact on their life.
Assessment using this system of assessment and lenses is available throughout the UK and is offered by more than 200 Optometry practices. Further details are available from the Society for Coloured Lens Prescribers website. www.s4clp.org.
Mr Stuart Henderson Bsc (Hons) MCOptom
Competing interests: The author is a practicing Optometrist, who uses the Intuitive Colourimeter in his professional practice and dispenses Cerium precision tints.
As an "Irlen's sufferer" I find myself quite torn with this article, as I can understand the concern being addressed in regards to some people being misdiagnosed.
I was diagnosed when I was 8 years old, I recall it very well. I was given no indication why I was seeing this consultant, I was also given no prior knowledge of any symptoms. My parents were very skeptical at first, but were deeply worried of my performance in school so it was a last measure. They were very away that my performance didn't make sense since I was described by teachers are being very articulate for my age group, I have old school reports of teachers claiming my verbal spelling ability was well above my age, yet I could barely read a sentence under 10 minutes with writing being out of the picture completely, which obviously makes little sense. This led some teachers to believe I was "Lazy" for which I was actually bullied by said teacher.
When it come to being diagnosed I hit the nail on the head with every single symptom, such as "If I look away and look back fast enough, I can catch the letters", "The heads move about" so there is little doubt there is something very wrong with certain people such as myself. My parents were instantly convinced and like many I got my glasses, I can't say with a straight face they completely worked, but without a doubt they helped. I like to say I had a window of opportunity without glasses of about 15 minutes until its effectiveness wore off and about 30 with them on.
In the same breath I can't say I'm exactly like other Irlen's sufferers since I can read a computer screen with little issue (No movement, Shaking, Merging of text etc etc) Whereas other sufferers seem to have it bad on both mediums, although I will clarify that although I can read text in books now albeit very slowly, it doesn't look remotely the same as it does on either. So basically I had to learn to read the same text twice because of the differences, and my writing capability although very slow and tedious to do, I manage to do "almost" entirely by muscle memory. Sadly this leaves my writing very untidy which gets progressively worse the longer I write.
So even though I do find your article somewhat offensive, I can understand your concern in regards to over diagnosing people. I don't actually bother with the lenses myself since I feel its the equivalent to duct taping a leaky pipe. Its temporary and as suggested in the article ITS VERY EXPENSIVE!, which for me personally is little improvement for the price of them. Then again I was last tested at aged 8, I may have picked them based on preference of colour rather than effectiveness? Who knows, but it would be nice for these very real issues to be looking into by trained health professionals and hopefully help find a more effective method of treatment.
Competing interests: No competing interests
It all sounds too good to be true and too simple.
Gwyn is arguing that if it's a placebo effect then the Irlen patent is an expensive con-trick, and I must agree.
But can the strength of anecdotal support for colour filters be dismissed entirely? In these austere times we must look to every opportunity.
Offering rose-tinted spectacles to every (ophthalmology) patient we fail to please would see to me to be a good start. If anything qualifies as an ethical placebo surely its rose-tinted glasses!
Maybe Ophthalmologists can mount a controlled-trial using standard rose-tint as the control group, versus the full Irlen range??
Competing interests: No competing interests
Research using the Intuitive Colorimeter has been cited as supporting the Irlen filters both in the recent correspondence and on the Irlen website. There are fundamental differences between the methods used by the Irlen centres and those of the Intuitive Colorimeter system, and in consequence of these differences, research using the Intuitive Colorimeter should not be taken as supporting the Irlen system. The research does show that coloured filters can have dramatic beneficial effects for some individuals, however.
The Intuitive Colorimeter is an apparatus that illuminates text with coloured light and permits the separate and precise control of the hue, saturation and brightness of the light. While working at the Medical Research Council Applied Psychology Unit, I designed the original version of the instrument to investigate the claims made by Irlen and the reports of benefit from patients using her lenses, which are proprietary. The colorimeter allows the effects of a colour to be studied while the eyes are adapted to that colour and the absence of surface colours avoids contamination of the judgment by colour constancy. It is simple to assess the consistency with which individuals choose a colour and to do so without their awareness. This is important because individuals who are inconsistent in their choice are not good candidates for tints.
Using this instrument I discovered that some individuals with reading difficulty reported distortions of text that abated when the text was illuminated by light of a particular colour. The colour was remarkably specific and different for each individual. Eventually it became apparent that coloured lenses were a satisfactory alternative but only if they provided an exact match to the colour of light chosen in the colorimeter. With Tim Noakes I then evolved a system for tinting lenses the precise shade. We used seven stable rapidly absorbed primary dyes with colours evenly spaced around a hue circle. The system can obtain a very close approximation to any colour in a large gamut. The dyes were chosen to have the maximum transmission possible. They vary smoothly across the visible spectrum, so as to minimise the changes in colour (metamerism) that can occur when the lenses were worn under lighting with a peaked spectral power distribution. The colorimeter was redesigned so that its coloured light had a spectral power distribution identical to that experienced when the lenses were worn under conventional white fluorescent lighting (CIE F3). This meant that anomalous colour vision could be accommodated. White fluorescent light is stable over time and has a colour midway between the yellowy white of incandescent light and the bluey white of daylight. The lenses were therefore appropriate for classroom and office use and the colour the patient experienced differed minimally under other lighting.
The Colorimeter system has been used in two double-masked trials. The Colorimeter permits a double-masked protocol because the patient adapts to the coloured light and is unaware of its precise shade and strength. Two types of lenses were provided. One matched the chosen colour and the other differed by 6 just-noticeable differences, a colour difference just sufficient to negate any benefit. The lenses were provided, each for at least a month in random order, and patients were later unable to say which was which. (Memory for colours is poor unless the shade can be easily named). Both studies showed a reduction in symptoms on days when the correct lenses were worn relative to days when the control lenses were worn. The first study has been criticised for an unacceptably high attrition, and the second for its small sample size, and further large-scale randomised controlled trials will be necessary.
There is little to suggest that the benefits of coloured lenses are due to the optics of the eye, in particular accommodation. The lag in accommodation has been shown to be greater in individuals with visual stress, but colour does not appear to influence the lag by virtue of chromatic aberration. Instead the pathophysiological mechanisms appear to be cortical. There is convergent evidence that in patients with migraine the cortex is hyperexcitable. There is an abnormally large haemodynamic response in the visual cortex when patients with migraine observe patterns of stripes, and this is reduced to normal levels when the stripes are observed through lenses tinted using the Colorimeter system. Control lenses (grey and coloured) are without effect. This suggests that precision tints may be a useful treatment for some patients with migraine, those with photophobia whose attacks are visually triggered.
Whatever tinting system is used, the assessment is subjective and dependent on the clinical skills and experience of the examiner. At present the only objective physiological correlate of likely benefit is the reduction in abnormal brain oxygenation as revealed by the haemodynamic response referred to above. Sometimes the benefit extends to an improvement in reading speed, however, and this can be assessed using the rate at which a paragraph of randomly ordered common words is read aloud (Wilkins Rate of Reading Test). This rate has been used to investigate the precision in colour necessary for optimal effect, and by implication, the number of trial lenses necessary in any tinting system. Both in children and adults an improvement in reading rate is commonly observed with coloured filters, even by investigators who are unsympathetic to their use.
Unfortunately, there is sometimes a tendency for examiners to over-prescribe, perhaps in the desire to help. Although Richie et al failed to find an improvement in reading rate in clients diagnosed with Irlen syndrome by an Irlen diagnostician, this cannot be taken as evidence that coloured filters, appropriately selected and prescribed, are unhelpful for the patients that need them.
For further details, please see the following reviews: Wilkins, A.J. (2012). Origins of visual stress. In J. Stein and Z. Kapoula (ed.) Visual aspects of dyslexia. Oxford University Press: Oxford. pp 63-78 and other articles, particularly those entitled Vision and Reading Difficulties 1-5, downloadable from www.essex.ac.uk/psychology/overlays/publications2.htm .
Arnold Wilkins, University of Essex
Competing interests: The Medical Research Council holds the rights to the Intuitive Colorimeter. The author receives an 'Award to Inventors' from the Council based on sales of the instrument. No royalties are received from the sales of tinted lenses.
The author of this paper demonstrates a lack of understanding of what Irlen Syndrome is. It is not a ‘”common eye disease” as he refers to it. It is not a vision problem that can be corrected by optometric lenses. It is a visual processing problem. Many people who have Irlen lenses also have optometric lenses, but these do not remove the visual distortions or discomfort experienced by people with Irlen. The optometric lenses are tinted so that the person’s vision is corrected and at the same time, their visual processing problem is also corrected. He seems to imply that all of the people who attend clinics who already wear optometric lenses have not been treated correctly, because according to him, if they received “proper treatment” then their reading difficulty would be corrected. He also states that people with Irlen have “..vague collections of symptoms .. tend not to trust eye professionals”. If this was the case, then there would be no people with Irlen lenses who also have optometric lenses. As Irlen Practitioners, we tell our clients that they should have their vision checked before getting Irlen lenses, to ensure that their problem is not vision related. So there is recognition within the Irlen organisation that ophthalmological assessments are essential before considering Irlen Syndrome as a cause of their difficulties.
His assessment that Irlen lenses are “… worthless bits of coloured plastic…” is an insult to the thousands of people who rely on their Irlen lenses to help them cope with the discomfort and distortions caused by the need to work on white paper under fluorescent lighting. He should understand that clients who have purchased these “worthless bits of plastic” include teachers, doctors, lawyers, politicians, nurses, business owners, psychologists, speech therapists, occupational therapists, and psychiatrists. If he took the time to find out whom some of these people are and spoke to them about their experiences, then he may be able to speak about Irlen Syndrome with some knowledge other than from his own biased views.
His reporting of Helen Irlen as a “US literacy instructor” implies that this is her only qualification. In reality, she is a registered psychologist who has worked as a school psychologist, family therapist, assistant professor of adult learning disabilities at California State University/long Beach, instructor in psychology at Cornell University and founder and Director of the Adult Learning Disabilities Program at Cornell. So to refer to her as a “US literacy instructor” is very misleading and in fact wrong.
He has quoted six references so it is assumed that he has based his paper on what he has read in those six references. The problem with this is that it appears that he has selected these papers to support his views. As all scientific researchers know, it is easy to present a biased view of research, and in fact, two separate research groups could analyse the same data and come up with different results and conclusions.
His comment that “… attributional bias is at play: general improvement over time with practice, unrelated to the lenses” is quoted from one reference. The author of this reference actually stated that “ The results support some predictions of the theory of attributional bias, but more research is needed to assess each theory of reading speed.” This quote has obviously been taken out of context and used to support his view about Irlen Syndrome. For video evidence to show that using a coloured overlay can improve a child’s fluency immediately, and without any practice, he should see the following YouTube video.
https://www.youtube.com/watch?v=rsqMe4JpauU
The suggestion that there have only been “ … few published studies shown to support the existence of Irlen Syndrome” shows that he has not done an exhaustive literature search himself, but has relied on the reference by Hyatt et al.
He reports that Irlen states that “…only Irlen centres can provide the correct colour tint ….and other specialists, including every optician, will simply not do” but in actual fact, the Irlen website states “..Colored lenses provided by optometrists and vision specialists to treat reading problems are NOT the same as the Irlen Method.” It does not say “…Even coloured lenses that look the same will not work”, but rather it states that “These professionals do not have the right colors, or diagnostic process for color selection.” This is because the Irlen lenses use different combinations of colours in specific ratios designed to remove specific wavelengths from white light and because Irlen Practitioners utilize a particular method to ensure that reading rate and accuracy is improved by the selected tint.
His final paragraph is astounding in its arrogance. “This is not harmless”. Is this evidence-based research? If so, where is the research published? Again, there is the reference to the “medical profession”, which shows a lack of knowledge about Irlen Syndrome because it presently is not identified as a “medical” problem. When prescribing optometric lenses, one assumes that he questions his clients with the following questions when determining what correction is required. When testing different lenses, the question is usually, “Which is better? This one or this one?” or “Which is clearer? This one or this one?” So he, like all ophthalmologists and optometrists are relying on what the client is telling them. Where is the objectivity in that? In some cases, corrective lenses that have been prescribed to children and adults alike actually cause headaches and sore eyes, so in those cases it could be said “This is not harmless”.
Competing interests: No competing interests
Again many thanks for your contributions. Yes Michelle Hutchinson and Morag Ward the placebo effect is very powerful indeed. The Irlen group take advantage of this and the fact that Irlen Syndrome is a registered trade mark should speak for itself.
I am grateful Marcia Guimaraes for your kind offer to travel to Brazil to 'visit the practice where you will have access to thousands of patients´ files rigorously recorded, with follow-ups of many years. It is based on all that I can assure you of the benefits of spectral filters.' If you think you have any evidence in your files which would convince me I would encourage you to publish it so that it can be available to the entire medical community.
Competing interests: No competing interests
Re: Irlen syndrome: expensive lenses for this ill defined syndrome exploit patients
Thank you Arnold.
I take your point about the CONSORT guidelines not being available in 1994. However, the principle of to trying to account for missing data or at least acknowledging the weaknesses of the data was extant at that time.
I also acknowledge that it was a pioneering study and big step forward in actually accepting that this subject could be addressed scientifically. As often happens with a first trial, it pointed the way to better trials.
Although you are circumspect in your interpretation of the data, others are not.
Returning to your specific points. Although the drop rate was high for both parts of the study. If I am reading your paper correctly, for the Neale reading test you had follow up of 45/68 whereas for the symptoms diaries 36/68 so I can think can argue that the data is stronger for the arm of the trial looking at reading.
I am not sure that I follow your point about reading improving in both the placebo group and optimal tint group. That either points to placebo or Hawthorne effect or that you do not need the precision in the choice of filter that you and others claim.
Although you say that no trial can prove a negative this is not entirely true. It is possible to do a power calculation an estimate the likely-hood of missing a clinically meaningful response.
The onus is on those promoting a treatment to prove an effect not the rest of the world to disprove it. Otherwise, therapeutic anarchy is the result.
Competing interests: No competing interests