Vision Therapy Clinical Trial for Convergence Insufficiency

[summerreading]

I am sharing this from a vision therapy group I follow on facebook (Vision Therapy patients unite)

 

If your child has 20/20 eyesight, yet gets headaches, sees double and blur, squints or closes one eye and have difficulty reading, he/she may have an undiagnosed condition called Convergence Insufficiency (CI). Other symptoms include short attention span, fatigue and even bad grades. Researchers are now looking for over 300 children with CI to participate in a clinical trial to see if vision therapy can help with reading and attention. To see if your child is a candidate, check out www.citt-art.com ‪

[Tess in the Burbs]

too bad the locations are too far from us.  DD would totally fit this study. 

[PeterPan]

nt

[summerreading]

too bad the locations are too far from us.  DD would totally fit this study. 

 

Sorry, I should have put the locations: "The CITT-ART study is being conducted at 8 pediatric eye care centers across the United States. The study is funded by the National Eye Institute, which is part of the National Institutes of Health. About 325 children will take part in this study."

• Southern California College of Optometry at Marshall B Ketchum University
• Pennsylvania College of Optometry at Salus University
• The Ohio State University College of Optometry
• NOVA Southeastern University College of Optometry
• University of Alabama School of Optometry
• State University of New York College of Optometry
• Akron Childrens Hospital
• Bascom Palmer Eye Institute

 

I think it did say that half the participants will be given a "placebo" VT treatment, which I think kind of stinks. But if this help validate VT and maybe insurances will start covering it more, and someone out there can get free VT for 16 weeks, I thought it was worth sharing.

[displace]

I used to live in a couple of those cities but not now. I hope they get conclusive evidence!

[geodob]

Their is a real ethical concern about this trial?

Where 1 in 3 children will recieve a placebo therapy.

 

Which will require each child to attend weekly office therapy.

As well as do 15 minutes a day, of home exercises.

The trial concludes with a vision test 1 year later.

 

Which is most likely when parents will be advised that their child recieved the placebo therapy.

Participation would no doubt also require not having any other vision therapy, during this year?

As this would confuse the results.

 

So that children will be delayed for a year and 16 weeks, before recieving authentic therapy.

 

Also the parent will have to explain to their child, that the 15 minutes of daily  exercises and weekly office therapy?

Were actually a waste of their time, as they were fake exercises.

 

Though I also noted on the links, that their is no mention of the trial having approval by the Ethical Research Council?

 

But then, this is actually a Trial, rather than Research?

Where they are just Trialling a Product, a therapy program that they have developed.

Which might turn out to be no better than the placebo?

 

So that basically it's just a trial of a so far, untested product.

Where their is a real concern about involving children in a product trial?

[PeterPan]

I keep trying to walk away from this, but I agree with geodob that people are being naive if they think this is some conclusive study.  It's universities for the most part, and around here the major university isn't where people with money go for VT.  The BEST places are private.  So I question the qualifications and experience of the people doing the VT, and VT is totally about the therapist, meaning experience matters.  That's like the King-Derick study on rapid naming I linked in another thread.  Just because a university did it doesn't mean they were at the cutting edge.  Their rapid naming work doesn't reflect all sorts of nuances other therapists have brought in.  So now we have some tit for tat, this org, that org, I'll prove it because I'm more official than you are? Or I'll disprove it because I used therapists where weren't COVD certified but did something and called it VT?

 

And yes, that's the trouble in the studies I've read of other things like neurofeedback.  Compliance drops when the participants get into it and realize they got the sham.  It's challenging to create a situation with actual controls for these therapies.  And yes, I would consider that downright reprehensible to knowingly give a parent faulty therapy.  I don't care if they think it's so virtuous.  Children OUGHT to be treated for known problems.  And based on what I've seen in other studies, I'll bet their compliance drops when the parents realize they got the sham and no progress is being made.

[City Mouse]

I would not want someone to avoid participating due to negativity on this board. Research studies are a necessary process of scientific research. Also, not everyone has the resources to pay for "the best" even if it is available.

 

As far as being at a university, where do you think all tho see COVD doctors got their training? Optometry schools do use students to give exams, but they are supervised, and those exams are often very detailed. The supervising doctors are often the experts in their fields who are literally writing the book on the subject. Who could be better to supervise these new practitioners? I have personally used an optometry school for services, and thought it was as good as any private service provider. Also, I have take many students to the optometry school for specialized services that are not available any where else.

 

If you follow the like to clinical trials dot gov there is much more detailed information that what is in the first add.

[PeterPan]

Can you imagine the complexities of a study like that?  I mean, trying to state whether VT "works"?  Not "does our particular variant and method of VT work" but does it work at all???  I mean, mercy, we can tell from the board here that's fraught with complexities.  You can have all sorts of OT issues that get in the way.  They'd either have to screen those kids out entirely or expand the study a lot more.  Or "treat" them by some system by which they treat everyone and then say it didn't work for a percentage when it was the system.  

 

I'm taking issue with the sweeping nature of what it implies they can be conclusive about.  I'm sure they'll have to address that.  I'm just saying as consumers those are questions to ask.  The whole premise seems illogical to me.  You'd have to tighten it to specific populations, specific methodologies, and EXCLUDE all sorts of situations to get meaningful results, and even then they could be incorrectly concluded as applying to ALL of VT when they'd only apply to the particular scenario they used in their study.  

 

If it were my kid and I were able to get into the study and money was tight enough that I was willing to take a chance, sure I'd do it.  But honestly if I were into it and realized we had gotten the placebo, I'd leave and go get real therapy.  But to apply and see if you'll get in and be one who gets actual intentional care, sure that's great.  And to say the truth, that you'll be happy if you're the one getting free care and upset if you get in this pickle of realizing you're not getting care and feel morally compelled to continue (and not help your own child), that's a mess.  They *can* design better studies.  I've read about some of them that managed to deal with the problem with neurofeedback.  They had that very problem, that once the parents figured out it wasn't real treatment compliance dropped and people left.  They got creative and found other ways around it.  

[geodob]

It needs to be noted, that this is not research into Convergence Insufficiency.

But rather a trial of new therapy that they have defined.

Which may turn out to be no better than the placebo?

 

Its conclusions would have have more validity, if the placebo was a proven therapy.

So that a comparison of its effectiveness, can made.

 

But it states: " However, to know for sure we need to study this question in a larger group of children using a randomized clinical trial design with some children receiving a harmless control therapy that is not designed to treat CI."

 

Forcing a child to do 15 minutes a day of ineffective CI therapy, and and weekly office therapy, for 16 weeks.

Cannot be said to be 'harmless'?

Where a child will no doubt become aware that it isn't helping at all, after maybe 4 to 6 weeks?

So that the parent might then have to 'force them' to do the daily home exercises?  For the next 10 to 12 weeks.

 

I cannot see how forcing a child to do useless exercises for 15 minutes everyday?

Where the parent will be repeatedly telling the child every day. That they have to do them, because they will help.

 

When the child finds out the truth, about what they were forced to do?

What harm would this have done, to a child's long term trust in their parent?

 

Also they state that they will recieve a 'harmless control therapy'.

But can they prove that it wont be harmless?

That it wont have any negative effect on their vision?

Or are they using harmless, in terms of, 'it wont help improvement'?

 

Though to know more about this, I just enrolled in a NIH Office of Extramural Research course. 

[PeterPan]

Nicholas Lofthouse is a researcher psych at OSU looking into neurofeedback, and in their studies they've had a similar situation, where they wanted a control but knew the control group would not be receiving therapy.  Here's an abstract of one of the reports.  http://jad.sagepub.com/content/16/5/351.abstract  I can't find a full pdf right now, but I know I read it for one of the studies.  Anyways, long and short was that, as you predict, as soon as participants figured out they got the sham therapy, compliance dropped dramatically and those people dropped out.

 

Thing is, with neurofeedback at least you have a therapy that's OPTIONAL, a therapy that might or might not work.  If the kid doesn't get it, life goes on and he's not harmed.  But to withhold VT, I'm sorry but THAT is harm.  Simply the fact that you're withholding a known therapy that is known to be effective from someone who has a disabled state without receiving the treatment, that's outrageous.  And it's a child.  

 

We know VT works, so for someone to wittingly withhold VT from a CHILD when we already KNOW it works is harmful.  That's like saying I won't give you glasses because you can still hobble without them.  I won't give you food because I need to prove feeding works.  Outrageous.  We already KNOW.  They could figure out how to do this without withholding vital therapy from kids they have IDENTIFIED as needing it.  Now to compare two TYPES of VT, that might not be so bad.  But *I* wouldn't let my child go without VT just because some researcher said please pretty please we'll pay you $30 if you keep your kid in our not VT placebo group for 12 or 16 or whatever weeks.  That's a semester of school.  In that amount of time some kids will LITERALLY go from not reading to reading.  That $30 isn't worth it.  So if you got in the real group (and if their variant of VT is effective) you got a great deal.  If you got in the placebo group, you got screwed.

[OneStepAtATime]

In reading this thread again I think I have to agree with geodob and OhE.  DS hated every minute of VT.  It was HARD.  If he had already been through some sort of plecebo trial where I kept telling him it would help when in fact it wouldn't help at all he would have felt betrayed.  And I seriously doubt he would have done ANY VT without a huge fight and might not have participated for anything.  He might not have even agreed to do any remediation of any kind in any area.  I would have betrayed his trust and that might have triggered tremendous push back.  Both kids are already very distrustful of "experts" since we have been burned so many times.  

 

I know that clinical trials are so important.  But in this case, I just could not, in good conscious, sign my own child up for something like this..

 

I appreciate summerreading posting this, though,  It has made me think long and hard about some things we are considering.  Besides, there are those who might very much want to participate that would feel differently than I do.  Thanks, summerrading, for the post. 

 

Best wishes to all...

[PeterPan]

Wow OneStep, I hadn't even thought through the psychology of this from the child's perspective.  I was just thinking like a Mama Bear.  Yeah, by the time the kid figures it out, he might not be WILLING to do real VT.  What a crock.  Which makes me totally doubt the common sense and motivations.  Turf wars.  To me it sounds like people who aren't doing a lot of VT going "we got a program, we'll all do it, and then we'll see if it works."  People who've actually DONE a lot of VT would see the flaws and problems.

 

And I agree, it's nothing personal about summer reading.  I think it's great that she shared and I hope that anybody who does this trial gets great results.  And shares about them.  :)

[umsami]

wrong thread. :)

 

[OneStepAtATime]

wrong thread. :)

:lol:

 

Well, you are welcome to hang out anyway.  :)

[summerreading]

I feel bad for posting it as I obviously didn't look too much into it or think about the implications.

I wonder how the researchers would defend it, maybe I will post in the group I am on to explain their methods and why.

 

[OneStepAtATime]

I feel bad for posting it as I obviously didn't look too much into it or think about the implications.

I wonder how the researchers would defend it, maybe I will post in the group I am on to explain their methods and why.

Oh goodness, don't feel badly!  It opened up an interesting discussion and some useful responses.  

 

And I would be very interested to know how the researchers would defend what they are trying to do.  I am certain they are not trying to cause any harm.  I just wonder if they have thought through some of the ramifications.  I certainly hadn't when I first read your post.  :)

[PeterPan]

I feel bad for posting it as I obviously didn't look too much into it or think about the implications.

I wonder how the researchers would defend it, maybe I will post in the group I am on to explain their methods and why.

 

Just because *I'm* cynical doesn't mean they won't help people.  Are you close enough that you're thinking about participating?  

 

But yes, if you're on a group where they have access to people within the study, you could ask the questions geodob is posing about who has reviewed the study, what the ethics of it are (withholding therapy from kids they've diagnosed as needing it), etc.

[Rod Everson]

Adults sign up for trials all the time, knowing that they might get the placebo instead of what they hope will be a potentially life saving drug or procedure. Why? Because they're dying. If the trial proves a drug/procedure has benefit, logically they'll get it later if they only got the placebo at first.

 

Similarly, adults make decisions about their kids everyday, decisions that often affect their kids' lives over the long term. One such decision is obviously, to homeschool, or not to homeschool? Another is whether or not to try vision therapy. What if, as i often the case, money is a huge obstacle? So, they enroll their child in a trial hoping for a good result but their child ends up in a placebo treatment. If the trial is wildly successful, what parent wouldn't then switch to the effective treatment if given the chance?

 

Two points: The placebo treatment should obviously come with an offer of a free course of the effective treatment, should it be shown to be effective. Also, the placebo should be "harmless." Those of you arguing that the child won't later undergo VT are implying that the placebo isn't harmless because a child won't go through VT later having undergone the stress of the placebo treatment. You're therefore assuming that the placebo will be as stressful as VT. That need not be the case. In some studies, for example, the child just does another constructive activity involving reading, writing, or skills development. In the case of the study that's already been done on convergence insufficiency the in-office treatment involved doing vision work that was not intended to improve convergence ability, but that looked like vision work nonetheless.

 

The NIH has already overseen significant studies on the effectiveness of in-office VT as compared to the traditional pencil pushups often prescribed by optometrists and also as compared to a placebo treatment. The page Convergence Insufficiency Study on my site has links to those studies. (The links used to go to JAMA archives but it appears they now charge for viewing anything but the abstract so today I located online pdf's of the studies and now link to them instead.)

 

Incidentally, these were very powerful, "gold standard" studies that should convince a lot of eye care professionals, including some who have been critical in the past, that vision therapy is a valid procedure for addressing issues related to learning to read, and to reading comfortably. In fact, my first reaction to seeing this posting was that it's already been done.

[Rod Everson]

Wow OneStep, I hadn't even thought through the psychology of this from the child's perspective.  I was just thinking like a Mama Bear.  Yeah, by the time the kid figures it out, he might not be WILLING to do real VT.  What a crock.  Which makes me totally doubt the common sense and motivations.  Turf wars.  To me it sounds like people who aren't doing a lot of VT going "we got a program, we'll all do it, and then we'll see if it works."  People who've actually DONE a lot of VT would see the flaws and problems.

 

And I agree, it's nothing personal about summer reading.  I think it's great that she shared and I hope that anybody who does this trial gets great results.  And shares about them.   :)

 

In the first studies done to determine whether symptoms of convergence insufficiency would be alleviated best by in-office VT, something like 90% of the parents couldn't determine that their child was in the placebo group, so I think they've got that part figured out.

 

As for this being some "program" that's being tested, the program is in-office vision therapy, the same VT that people have found success with (often anyway) in here. This is the sort of research that needs to be done to get others outside of COVD circles to accept VT as a valid treatment for reading issues. The very fact that it's being done under the auspices of the National Institute of Health is huge.

 

If you go into a school and speak to the LD coordinator and ask if VT is an accepted research-based treatment for reading problems, you'll likely be told that it isn't, and therefore the school won't feel responsible for offering it. This is exactly the sort of study that needs to be done to break down that sort of resistance and I, for one, am delighted to see it being carried out. If it shows what I suspect it will, hundreds of thousands of struggling readers could finally someday be offered the help they need instead of being pigeon-holed by teachers and administrators into resource rooms where they're asked to do what they're physically incapable of doing day after day after day, i.e., learn to read.

 

As I said at the outset, the initial studies have already been done. The current study is aimed at more directly linking VT and reading, rather than just linking VT and symptoms of convergence insufficiency (many of which look a lot like reading issues.) If VT improves reading levels, as it will in many cases in my opinion, that will open a lot of doors. 

 

The only caveat I would offer the researchers is to not overlook the role that phonics instruction plays in learning to read. VT doesn't teach reading. VT makes it easier to learn to read but someone still needs to teach reading. Some kids have internalized enough phonics before VT that they blossom during therapy, leading parents to believe that VT teaches reading, but it doesn't; it enables it. If a child is hopelessly confused about how print works, VT won't necessarily create a better reader on its own. 

 

Were I to design a study following up the one under discussion here I would do a pre-VT phonics course and compare it to a post-VT phonics course. Over the years I've taught my phonics course, those who've already had VT have always been the easier of the two groups to teach, but someone eventually should do a gold standard study and prove it.