Idea for MGD treatment

[Richard_R]

They say there is nothing new under the sun. Probably true, but I figured I'd throw this out. It seems that the problem with the meibomi gland is that the oils are too thick. The treatment revolves around heating the oils up and making them run out easier. What we do is to apply warm compresses or hot water in the shower etc.

As an alternative, what if we applied a slightly elevated temperature for an extended period of time, say overnight. I'm thinking that if we could apply say 100 F to 103 F (experimentation needed here) regulated degrees to the eyes overnight (6 - 10 hours) maybe things could get to running more freely and possibly breaking the cycle. The device would be a goggles or eye cover of some type that would regulate the eyelid temperature to just a few degrees above body temperature. This procedure differs from others because it is relatively low temperature and extended time, instead of high temperatures for short times. I am certain that maintaining too high of a temperature too long is not good.

Anyone ever heard of such a device? Anyone know how to do this? Maybe a doctor or researcher knows what the melting range of the bad lipids is.

Richard.

[Richard_R]

I did some looking and found this patent application for a similar device called "melting meibomian gland obstructions". It was filed in 03/07:

http://tinyurl.com/2za6tp

If you scroll down you will find lots of interesting information about MGD.

One section that I found interesting from patent application 20070060988 was:

The therapeutic temperature range has been determined to be greater than 37.degree. C. A range of approximately 44.degree. C. to 47.degree. C. is most preferable since temperatures approaching 50.degree. C. generally becomes difficult for a human to endure and may cause unnecessary pain or minor burns. A proposed target treatment temperature is 45.degree. C. as indicated by curve 25 (which provides a good balance between comfort and efficacy). Curve 25 illustrates a relatively constant 45.degree. treatment temperature for a specified treatment time (e.g., for embodiments consistent with the present invention, 10-20 minutes is preferred, with 15 minutes currently being considered a good specified time for most patients exhibiting mild to moderate MGD. For more severe MGD, between approximately 30 to 45 minutes has been found more effective. For extremely severe MGD, approximately 30 to 60 minutes is more effective. These times are for a temperature of approximately 45 degrees C., and may potentially be increased or decreased at other temperatures. In tests, ranges between 10 and 60 minutes are generally effective.

Richard.

[Rojzen]

fascinating! What about those iron-filing heat packs? Dr. Tsubota's little device

Richard - -I think your idea of sustained, slightly elevated temperature applied directly, is really brilliant!

Some years ago, Dr. Tsubota, famed for his ongoing research in DES, lent Dr. Tseng, in Miami, an electric heating device that he was using in Japan, and I was lucky enough to be allowed to keep it for a few months, between visits to Dr. Tseng. . .It was an electrified eye patch. . like a tiny electric blanket, attached to a small AA-Battery pack. . .The patch had a strap, to keep it on the eye. . .One was supposed to put the patch on, turn up the heat, keep it on a while, and then switch eyes... The temperature got pretty hot, but not unbearable. . .and it felt pleasant. . .I suspect Dr. Tsubota still has his MGD patients use these. . .and possibly the patent now being sought, in the U.S., for an MGD heat pack, is like Dr. Tsubota's. .

Anyway, as an MGD patient for whom regular applications of intense heat, not more than twice a day, has been of no use whatsoever, I am fascinated by your theory that a much more sustained, low intensity process would bring about better results. . .And applying the low heat at night is a brilliant way to accomplish this, I think. . .(An active person would have no other time for this, in any case. . .)

Are you thinking of working up a prototype? I have no idea how to do this. . .but the mini-electric-blanket concept might extend here. . .I think that if the device heated up too much, this would probably wake the patient before any harm could be done. . .

I must also confess that I have seriously considered cutting up one of those arthritis pain patches that you can now get everywhere (which heats up on air contact, and lasts for up to 10 hours), and putting a piece of it on my eyes. . .But I've realized that the heat level in this product (which uses iron filings) is WAY too high for safety, on the eyelids. . .Could such a product, with a small amount of iron filings, be adapted for us, possibly?

[Richard_R]

Rojzen,

I was hoping that I could find something that already exists. What we are looking for is a small thermostatically controlled heating pad. I am sure something like this exists but finding it is the problem. Maybe this company already makes something that would work:

http://www.heatact.com.tw/eng/produc...?pid=31&cid=66

If something doesn't fit our needs, it would seem that a simple design utilizing a small resistive heating element such as this:

http://www.heatact.com.tw/eng/products/index.php?cid=72

If this could be cut to our size and maybe even molded into a specific shape and then I am sure a simple circuit could be designed using a thermistor to control the surface temperature to a range of say 100F to 110F with a adjustment knob, one could see if the concept works. Probably wouldn't work in one day, but who knows.

Richard.

[sazy123]

I like your theory, isnt tranquileyes like this or is it not hot enough? i dont find tranquileyes very warm maybe i dont heat it up properly.

i dont think it would work on my MGs coz they dont seem to be blocked but good for peoples whos are, you should make something up for the eyes if it doesnt exist.

[bassfan]

Richard

I've also thought about the same type of thing. Heat instantly cures my DES problems. Just wanted to say its great that ideas like this out on the board.

Sazy - I dont think tranquileyes would give the extended warm temps that Richard is proposing.

[Rojzen]

"eye cover"; the opposite of forcible lid expression; big lenses for securing

The products on the web sites you've located look promising, Richard. . and I am so grateful that you have done the research on appropriate temperatures (through review of that interesting patent application. One of the products on the sites you referenced mentions an "eye cover," but then does not display this item. Not clear whether that eye cover is intended to be a heating device, or just an accessory to heating devices for other parts of the body. . .

Yes. . .results could not be expected in a day. . .and who's to say how long slow, sustained heating would take to make a difference in those having the potential to improve through it? . . .My completely unscientific guess is that if this approach could keep meibum flowing, it would take about a month for that to happen. . .and that the treatment would have to continue indefinitely, given the tendency for MGD patients to re-block. .

On a related note, have you ever experienced meibomian gland expression of the rather forceful kind? I had one lower lid done, years ago, up in Boston, by a doc who used really brute force to eject plugs from my glands. . .Alas, I'm not even sure there were plugs to remove (I have metaplasia, which is actual skin overgrowth), but the damage done lasted for months, and I ended up with a lid swelling that scraped my ocular surface for a long, long time. . .I mention this because your idea, Richard, is so thoughtful, in a way that the very forceful method may not have been. . .What good is it to dynamite out a plug, when this leaves behind the worst possible environment for keeping a duct open. . .?

Looking ahead, if we ever find something that will produce the sustained low heat, there should be little difficulty adapting something to keep it on the eyelids. . .I don't know Tranquileyes personally, but the Gulden Ophthalmic co. makes a big, ski-type night goggle for people whose eyelids don't close fully. I have a pair, and I think they would do nicely to secure an underlying heating pad, without pressing directly on the heating elements, because of their large lens size.. .

[bassfan]

I'd like to hear Dr Latkanys take on this...he may have valuable input on these types of things already done.

Rebecca - If you see this, can you add a link in his forum or something so he could weigh in...however you can do it?

thanks

[Rebecca Petris]

I'll let him know.

Interesting topic. Personally, I would want to see some science behind this (would even be willing to participate in a study) before suggesting people experiment with any continuous heat delivery mechanism. Sounds possibly promising in theory but... again, to be on the safe side it would be helpful to know more. As we know from other treatments in this area more is not always better. Like I said though I'm intrigued and will make a note to follow this more carefully.

The good news is there is finally, finally more attention being paid to heat. While there are many marching to the Restasis drumbeat and nothing else, there are others working to uncover more information on the MGs and what makes them tick. After a long hiatus I've finally found a few spare moments to go through Medline and update my blog and this is one I came across on the topic:

Temperature-induced conformational changes in hman tear lipids hydrocarbon chains
Biopolymers. 2007 Jun 28; [Epub ahead of print]
Borchman D, Foulks GN, Yappert MC, Ho DV.

As a first step to characterize human meibum and tear lipids, infrared spectroscopy was applied to characterize the molecular structure/conformation and packing of hydrocarbon chains. Temperature-induced phase transitions were fit to a sigmoid equation and were experimentally reproducible and were similar for multiple samples collected from the same person. No hysteresis was observed. Hydration of polar tear lipids increased their phase transition cooperativity, enthalpy and entropy. Hydrophobic interactions in meibum lipid (ML) were stronger than in tear-fluid lipids (TL), as reflected by the higher entropy and enthalpy of the gel to liquid crystalline phase transition of ML.The results of this study provide further evidence of the differences in the composition and structure of ML and TL. The conformational changes observed in the hydrocarbon chains of ML with temperature suggest that the observed therapeutic increased delivery of ML with eye lid heating could be related to the increased disorder in the packing of the hydrocarbon tails. This work also highlights the power of infrared spectroscopy to characterize molecular structure/conformation, and packing of human tear lipids and provides a basis to be applied next to study tear film lipid composition-structure-function relationships and lipid-protein interactions in relation to age, sex and dry eye symptoms. (c) 2007 Wiley Periodicals, Inc. Biopolymers, 2007.

[Rojzen]

heat and lipids loosening other lipids

Yes - -we must find or make some science on this. . .Thank you, Rebecca, in this connection, for finding that excellent research piece on heat and meibum.

Possibly I should put this next thought elsewhere. . .but our discussion of heat, and melting of hardened meibum, reminds me of a fascinating approach that Dr. Eiki Goto, protege of Dr. Tsubota, proposed, a few years back. . .He did castor oil studies, and his objective was not to see whether simply adding castor oil to the tear film normalized it, or improved TBUT. . .but, rather, whether the castor oil that seeped in to any open meibomian glands would penetrate and loosen hardened meibum, and, after a time, restore flow to the gland system. I read one article in which the findings indicated that Dr. Goto had succeeded. This was long after castor oil had become a mainstay as a vehicle/adjuvant in artificial tears; but right after Dr. Goto's study was published, if I recall, Refresh came out with Endura, which is simply Restasis without cyclosporine, I think, and which contains castor oil.

For what it's worth, as much as I loved Dr. Goto's idea (and I got to be his patient, for a little while, when he was doing post-doc time with Dr. Tseng), ophthalmic castor oil, either compounded specially for me, or as Endura, never did me any good.

Anyway, this all goes to the idea of loosening up meibum. . .There will be mechanical/physical ways (e.g. heat), as well as chemical ways (lipids loosening lipids), for sure. . .

[Richard_R]

The products on the web sites you've located look promising, Richard. . and I am so grateful that you have done the research on appropriate temperatures (through review of that interesting patent application. One of the products on the sites you referenced mentions an "eye cover," but then does not display this item. Not clear whether that eye cover is intended to be a heating device, or just an accessory to heating devices for other parts of the body. . .

Yes. . .results could not be expected in a day. . .and who's to say how long slow, sustained heating would take to make a difference in those having the potential to improve through it? . . .My completely unscientific guess is that if this approach could keep meibum flowing, it would take about a month for that to happen. . .and that the treatment would have to continue indefinitely, given the tendency for MGD patients to re-block. .

On a related note, have you ever experienced meibomian gland expression of the rather forceful kind? I had one lower lid done, years ago, up in Boston, by a doc who used really brute force to eject plugs from my glands. . .Alas, I'm not even sure there were plugs to remove (I have metaplasia, which is actual skin overgrowth), but the damage done lasted for months, and I ended up with a lid swelling that scraped my ocular surface for a long, long time. . .I mention this because your idea, Richard, is so thoughtful, in a way that the very forceful method may not have been. . .What good is it to dynamite out a plug, when this leaves behind the worst possible environment for keeping a duct open. . .?

Looking ahead, if we ever find something that will produce the sustained low heat, there should be little difficulty adapting something to keep it on the eyelids. . .I don't know Tranquileyes personally, but the Gulden Ophthalmic co. makes a big, ski-type night goggle for people whose eyelids don't close fully. I have a pair, and I think they would do nicely to secure an underlying heating pad, without pressing directly on the heating elements, because of their large lens size.. .

Rojzen,

If you click on the middle picture on the right, you will see a heating pad for the eyes. What do you think about us asking this company to make us a temperature controlled pad? Maybe if we asked them to make a knob-variable temp version 100F to 113F (38C - 44C) they would do it. Who knows, maybe they have done somethings like this. Looking at the other products they manufacture, it looks like they can do it. I think it would only be a matter of cost.

Another idea I had was to go with a goggle and to maintain the air pocket at some elevated temperature, say 100F to 113F that is controllable with a adjustment knob. You know this doesn't seem that hard to do. All one would need would be a small resistive heating element with temperature control powered by a DC power source. It would be safe and probably not too expensive.

Anyone else got any ideas?

RMR

[Rojzen]

FDA Catch-22 for medical device; out-of-the-box still needed

Yes, Richard. . I am totally in favor of our asking the company to make something to your specifications, because I don't worry terribly about placing something that is only slighter warmer than human body temp. on the eyelids, even for hours. . .(Summers in Cairo routinely produce ambient air temps near 120F, e.g.)

But I predict that the company in question will need to attach a major disclaimer to anything it produces for us, and will have, specifically, to decline describing the product as something that can come anywhere near the eyes. In other words, if the product were represented to be a medical device of any kind, there would be onerous FDA approval requirements that would put a quick end to the company's interest in cooperating. . .

So, thinking aloud. . .I suspect that no business concern is going to tailor something for us if they know what the intended application is. . and it probably isn't a great idea not to disclose our intentions. . .A veritable Catch-22. . .

This prompts me to think that we may have to jerry-rig something, if we are intent on testing your hypothesis. . .

In meantime, as we ponder this, maybe Dr. Laktany has been chiming in on this. . .

In that connection, I hope that any physician who considers this new idea will do so in the spirit of appreciating that the twice-daily hot pack/lid scrub/lid expression regime simply does not work for everyone. . .e.g.: I've had multiple docs (at Wilmer, Bascom Palmer, Wills Eye Hospital, Ohio State, University of Texas, Schepens/Harvard, Dr. Gilbard's institute, and elsewhere) tell me that some of my meibomians are still open. . .and not dropped out. . .and yet no amount of lid care, including heat pack therapy extending for periods of years at a time, has helped. . .Hence, the out-of-the-box approach is, I think, called for, for at least a portion of the DES population. . .

[Richard_R]

Rojzen,

Looking at this link:

http://www.ing-fischer.at/pdf/CT198_heaterstat.pdf

I think it would be rather straight forward to augment some sort of eye cover with a temperature controlled feature. If you look at the heaterstat product, you can see that you can control a large variety of pad heater elements at low DC voltage and control the temperature to just about any temperature you want. I can't see how there would be any hazard potential here, but as long as we are just trying to jerry rig this for our own use, I don't see there could be any problem. I don't know what this stuff costs, but they even have evaluation kits, so they can't be too terribly much.

The next thing I want to find is some sort of eyewear that could accommodate a pad of the 2x4 inch size or .75x4 inch pads. Not really sure how much power is needed but I would think that 3 - 5 watts would be enough. Better to err on the higher power side, the thing is temperature controlled anyway, so it isn't going to get any hotter than we set it to. That is going to take some experimentation. Maybe the eyewear heater product from that first company would be adaptable.

This whole thing should be able to be powered by one of those plugin dc powercubes things. They are cheap, no problem to get.

Anyone have any ideas here, now is the time to chirp in.

Richard.

[laine]

heat packs

The only thing that I have found is re-usable gel filled hand warmers. The ones I have are made by hotsnapz, they do get pretty hot though so I wrap a flannel around them before applying to eyes. They stay hot for about half an hour, maybe longer. I haven't been able to find anything that stays hotter for longer that I could use on my eyes. I know that there are one time use only thermo packs for body aches that stay hot for 6-8 hours but again, I don't think they are suitable for eye use. Someone needs to invent a re-usable heat pack that stays warm/hot for extended periods of time, especially intended for eye use that is hot enough to be effective but not too hot as to damage the delicate skin around the eyes. Moist heat doesn't work for me as the moisture irritates my tear glands.

[Rojzen]

Richard - - I must apologize for overlooking that eye cover that appears as one of the for-sale items in the collection of electrical heating pad products you discovered. Thank you for re-directing me to that.

Also, the company making these items clearly has no worries about medical applications and FDA approval, and so please scratch all that I wrote in that vein.

Accordingly, maybe there is no need to jerry-rig, unless the heat intensity in the existing product cannot be adjusted downward to reach your target temperature. Possibly that is the thrust of your last posting. .i.e., that we will have to substitute the company's existing power pack for an original one. . .And yet I think you are proposing that we ditch the eye cover, too, and create our own. . .

Please forgive that I've gotten a little lost here. . .and if I steered you away from the existing product, through my silly ramblings, perhaps we should reconsider working with the existing product in some way. . .