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DRUG HELPS RESTORE SIGHT: Relief for wet macular degeneration (miracle alert!)
South Florida Sun-Sentinel via MontereyHerald.com ^ | 8/5/2006 | NANCY MCVICAR

Posted on 08/06/2006 7:07:14 AM PDT by Dark Skies

Marion Kleinfeld got up one Sunday morning, picked up the newspaper, settled down to read it, and couldn't see the words.

Kleinfeld, 79, of Delray Beach, Fla., already blind in her right eye, lost sight in her other eye because of a condition called wet age-related macular degeneration, AMD, the leading cause of blindness in people over 55. Leaking blood vessels in the back of the eye cause a large black spot in the center of vision.

"I could not see at all. It was very frightening," she said.

After years of having to tell patients losing their eyesight to wet AMD that nothing could be done, doctors now can offer hope. On June 30, the U.S. Food and Drug Administration approved Lucentis to treat wet AMD, which strikes an estimated 155,000 people a year. The approval came seven years after the drug's maker, Genentech Inc., began the first test in humans, said Dawn Kalmar, a spokesperson for the company based in San Francisco.

About 95 percent of patients regain their sight after treatment, and in some, vision gradually gets better than it was before the onset of the disease.

When Kleinfeld's first eye developed the condition several years ago there was no treatment. But this time as soon as she got to retina specialist Mark Michels' office in South Florida, she got an injection that restored her vision.

"Within a week I could see again, and by the end of the month, I was seeing perfect," she said. "It was amazing how quick it happened."

Genentech makes another drug, Avastin, which retina specialists have discovered may work just as well as Lucentis and costs much less. It is approved by the FDA to treat cancer by stopping formation of blood vessels around tumors, but doctors can use it "off-label" to stop the leaking blood vessels at the back of the eye.

Lucentis, which is covered by Medicare, costs about $2,000 for one eye injection each month; Avastin costs $17 to $50 a month for one injection.

Kleinfeld got her treatment as part of a clinical trial of Lucentis, a biological drug that blocks a protein, VEGF, which causes abnormal blood vessel growth. She continued to get injections in her left eye once a month for 24 months as part of the study. She said the injections were not painful. Now she goes about every three months.

Clinical trials are continuing in South Florida and other locations to determine how many treatments should be given and how often.

"It's just a gift from God as far as I'm concerned," Kleinfeld said. "I can see my grandchildren. I have five beautiful grandchildren."

Dr. Philip Rosenfeld, professor of ophthalmology at the University of Miami Miller School of Medicine, said he initially tried Avastin in patients who were going blind and who were not being helped by earlier drugs approved to treat wet AMD.

"There's been a slow progression of therapies -- first there was Visudyne, which slowed the progression in some people, then Macugen, that slows the progression, then came Lucentis and Avastin, and for these drugs there's the possibility of improvement (of vision), which we've never seen before," Rosenfeld said.

According to Genentech, patients are not only able to read and drive again, about 40 percent can read three more lines on the eye chart than they could before the treatment. Avastin has had similar results for some patients.

"We just tried (Avastin) in a couple of patients at first with miraculous results," said Rosenfeld, who practices at UM's Bascom Palmer Eye Institute and has been involved in drug trials for wet AMD treatments for more than a decade, including Lucentis.

"We published those (Avastin) case reports," he said, and discussed his findings at a national meeting of retina specialists about a year ago.

"Outside the U.S., people can't really afford Lucentis," he said. "This spread like wildfire, so by the time the World Congress (of retina specialists) was held in February, the whole world was treating patients."

Rosenfeld said one Wall Street analyst estimated that Avastin had captured 80 percent of the market before Lucentis won FDA approval.

"It just goes to show you that if you provide an effective drug for an unmet need at an affordable price, there is no need for marketing and advertising," Rosenfeld said.

People who have Medicare, which covers the cost, usually choose Lucentis, he said. But people who don't have a supplemental policy may opt for the cheaper drug because the Medicare co-pay for Lucentis is about $400 and most people would have to pay that once a month.

Rosenfeld said the National Institutes of Health may sponsor a trial comparing Lucentis and Avastin.

While Kleinfeld's sight has been restored in the eye treated with Lucentis, there is still no treatment for the eye that lost vision years ago. There are no drugs that work for that. Some research is being done in animals using embryonic stem cells in the hope of being able to grow replacement tissue that will restore sight, but experts said clinical trials in humans are likely years away.


TOPICS: Culture/Society; News/Current Events
KEYWORDS: avastin; blindness; eyecare; eyesight; health; lucentis; maculardegeneration; medicine; vision
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1 posted on 08/06/2006 7:07:16 AM PDT by Dark Skies
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To: Dark Skies

I see Dark Skies.


2 posted on 08/06/2006 7:08:24 AM PDT by battlegearboat
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To: Dark Skies

-bflr-


3 posted on 08/06/2006 7:08:50 AM PDT by rellimpank (Don't believe anything about firearms or explosives stated by the mass media---NRABenefactor)
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To: Dark Skies

bump


4 posted on 08/06/2006 7:11:24 AM PDT by GlennLivett (Insula est scelestus interficio monastica quod Mohammed est abbas of totus monachus quod volutabrum.)
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To: Dark Skies
Lucentis, which is covered by Medicare, costs about $2,000 for one eye injection each month; Avastin costs $17 to $50 a month for one injection.

Someone is making a boat load of money off patients and taxpayers.

5 posted on 08/06/2006 7:14:09 AM PDT by mtbopfuyn (I think the border is kind of an artificial barrier - San Antonio councilwoman Patti Radle)
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To: GlennLivett

I see a bump in Genentech stock


6 posted on 08/06/2006 7:14:37 AM PDT by spokeshave (The Democrat Party stands for open treason in a time of war.)
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To: Dark Skies

Bump


7 posted on 08/06/2006 7:15:17 AM PDT by Enterprise (Let's not enforce laws that are already on the books, let's just write new laws we won't enforce.)
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To: mtbopfuyn
My dad has AMD and is going in for his annual checkup next week. Needless to say he is excited.
8 posted on 08/06/2006 7:19:09 AM PDT by Dark Skies
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To: Dark Skies

Bookmarking


9 posted on 08/06/2006 7:21:40 AM PDT by Ladysmith ((NRA, SAS) Gun owners have illustrated rights are individual and can be protected by individuals.)
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To: Dark Skies

bump for later


10 posted on 08/06/2006 7:26:08 AM PDT by true_blue_texican
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To: Dark Skies

Thank you for posting this.


11 posted on 08/06/2006 7:26:18 AM PDT by BenLurkin ("The entire remedy is with the people." - W. H. Harrison)
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To: Dark Skies

Good post. Thanks. I lost my right eye to retinal detachments a couple of years ago, so it is good to know that I may not lose the other one.


12 posted on 08/06/2006 7:51:52 AM PDT by billhilly
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To: Dark Skies

Thanks for the post DS! This is a good article to save for future reference! :)


13 posted on 08/06/2006 7:53:43 AM PDT by mkjessup (The Shah doesn't look so bad now, eh? But nooo, Jimmah said the Ayatollah was a 'godly' man.)
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To: battlegearboat
Thanks so much for this article!!!!!!!! I have had one eye operated on for cataracts and have an appointment for tomorrow for the other one. Last eye the Dr. said that there was the beginnings macular degeneration.

I have been so nervous about my appointment tomorrow. This will really help calm me down.

My husband is blind and one of us needs to see.
14 posted on 08/06/2006 7:57:51 AM PDT by Coldwater Creek ("Over there, over there, We won't be back 'til it's over Over there.")
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To: mkjessup

My pleasure!


15 posted on 08/06/2006 8:01:38 AM PDT by Dark Skies
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To: Dark Skies

"About 95 percent of patients regain their sight after treatment, and in some, vision gradually gets better than it was before the onset of the disease."


Sigh....another hopelessly sensationalistic headline.

A promising drug, BUT it must be understood that the "95 percent of patients who regain their sight" are from a very narrow group, selected for their chance to succeed. Throwing this drug at every patient with exudative maculopathy (wet AMD), would result in a much lower success rate.

Like any treatment, this drug's success hinges largely on the stage of the disease, the exact mechanism of tissue destruction and accompanying conditions.


16 posted on 08/06/2006 8:02:39 AM PDT by EyeGuy
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To: Dark Skies
Now...they need to work on a cure for the ever popular "Old Eyes Syndrome" which is a sister to MD. ;-)

Signed, a frustrated with not being able to read fine print, over 50 person

17 posted on 08/06/2006 8:04:05 AM PDT by NordP (The NEW YORK TIMES - All The News Jihadists Can Use! .....(RL 06/28/06))
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To: EyeGuy
My dad has macular such that he can see clearly enough in his peripheral vision to watch a Braves game on TV, but, of course, sees nothing in the center. Is this something that might be of help to a person in that stage.
18 posted on 08/06/2006 8:06:24 AM PDT by Dark Skies
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To: EyeGuy
"95 percent of patients who regain their sight" are from a very narrow group
You know this how? We're you involved in the trials? Is the data posted somewhere?
19 posted on 08/06/2006 8:09:41 AM PDT by oh8eleven (RVN '67-'68)
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To: Dark Skies
This is just as good at restoring eyesight, and no prescription required. :O)


20 posted on 08/06/2006 8:17:28 AM PDT by jdm (Another day, another Helen Thomas pic)
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To: neverdem

Ping


21 posted on 08/06/2006 8:19:02 AM PDT by annie laurie (All that is gold does not glitter, not all those who wander are lost)
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To: jdm

lol...cures poor eyesight and erectile dysfunction at the same time.


22 posted on 08/06/2006 8:20:21 AM PDT by Dark Skies
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To: Dark Skies

"My dad has macular such that he can see clearly enough in his peripheral vision to watch a Braves game on TV, but, of course, sees nothing in the center. Is this something that might be of help to a person in that stage."



The visual effects of ARMD are the same-loss of central vision, whether the mechanism is exudative maculopathy (wet ARMD) or the MUCH more common, non-exudative (dry) form.

A point to be emphasized: this irresponsible article failes to point out that the great majority of ARMD patients have the non-exudative form, which is not treatable, at least with this drug.

Even if your father has the exudative type of maculopathy, if the damage occurred some time ago, I would doubt that this drug would be of help to him; my understanding is that it has its greatest utility in patients CURRENTLY undergoing vision loss from the disease.

For your Dad, magnification is the best current solution. Applicable to the specific visual task you mention, TV viewing at intermediate distances, a spectacle-mounted telescope would probably be the best solution.

Of course he should check with his optometrist or ophthalmologist regarding the particulars of his particular case, and the resultant applicability of this, or any other specific treatment.


23 posted on 08/06/2006 8:20:38 AM PDT by EyeGuy
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To: EyeGuy
Thx for the info. I will keep my fingers crossed until we hear from his doc.

However, as to the following statement...

A point to be emphasized: this irresponsible article failes to point out that the great majority of ARMD patients have the non-exudative form, which is not treatable, at least with this drug.
...the title mentions the fact that this treatment is only for "wet" AMD.
24 posted on 08/06/2006 8:24:28 AM PDT by Dark Skies
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To: oh8eleven

"You know this how?

I've followed the studies and have been in conversation with a couple of retinal specialists."


"We're you involved in the trials?"

No. You?


"Is the data posted somewhere?"

Undoubtedly. Google the keywords. You will find that "success" and "success group" are at least very descriminately, if not narrowly, defined


But come on. One does not need to be a eye doctor, or a medical professional of any type, to have big red flags go up over a 95% success rate with any drug thrown at a BROADLY-DEFINED medical condition.


25 posted on 08/06/2006 8:29:25 AM PDT by EyeGuy
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To: Dark Skies

"...the title mentions the fact that this treatment is only for "wet" AMD."

Indeed it does, but then it goes on to make this grossly inaccurate statement:


"Kleinfeld, 79, of Delray Beach, Fla., already blind in her right eye, lost sight in her other eye because of a condition called wet age-related macular degeneration, AMD, the leading cause of blindness in people over 55."


ALL forms of ARMD are indeed the leading cause of blindness in patients over 55, BUT that includes the MUCH more common non-exudative form. Additionally, from the retinal specialists I have talked to the STAGE of the exudative ARMD is of significant importance in the treatment success.


26 posted on 08/06/2006 8:36:17 AM PDT by EyeGuy
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To: Dark Skies

My uncle has this and as a big reader, his quality of life has been seriously degraded.


27 posted on 08/06/2006 8:38:41 AM PDT by fso301
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To: EyeGuy
I see what you are saying. That is a misleading statement.

I imagine this article was written by someone who lacks the professional experience necessary to delineate the finer points of this condition and was just trying (as was I) to give a general heads-up to folks with family members who have AMD.

28 posted on 08/06/2006 8:40:59 AM PDT by Dark Skies
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To: Dark Skies

"I imagine this article was written by someone who lacks the professional experience necessary to delineate the finer points of this condition and was just trying (as was I) to give a general heads-up to folks with family members who have AMD."

But the problem for those of us in the trenches, is that we have to be the bearer of bad news when such an irresponsibly optimistic article is published. That, inevitably positions us as the bad guys (shoot the messenger syndrome). It has already happened to a small extent here on this humble FR thread.

Much could be said here about the inherent sloppiness of "journalism" in general, but that is well covered elsewhere on Free Republic.

My sensitivity to this kind of information dissemination comes from the office full of patients I'll have to face tomorrow, who will be disappointed when we relay the REAL facts about this treatment.

But let me go back to my FIRST statement, for SOME it is a very promising therapy.


29 posted on 08/06/2006 8:50:59 AM PDT by EyeGuy
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To: Dark Skies; jdm

Yep - I almost passed out from lack of blood to the brain.


30 posted on 08/06/2006 8:53:59 AM PDT by ErnBatavia (Meep Meep)
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To: EyeGuy
I've followed the studies and have been in conversation with a couple of retinal specialists.
You made the claim the results were less than honest - now back it up with the data, not anecdotal information.

One does not need to be a eye doctor, or a medical professional of any type, to have big red flags go up over a 95% success rate.
Jonas Salk would be interested to know that.
31 posted on 08/06/2006 8:58:20 AM PDT by oh8eleven (RVN '67-'68)
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To: Dark Skies
My Mom started treatments earlier this spring. First shot did not seem to do much. Since the second shot (in the eye) her vision has been getting better. I note that she is not needing the special fluorescent light to read now. So far, so good.
32 posted on 08/06/2006 8:58:27 AM PDT by Blue_Spark
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To: oh8eleven

"You made the claim the results were less than honest - now back it up with the data, not anecdotal information."

I absolutely did NOT. I said the results were painted IN THIS ARTICLE with much too broad a brush. I don't respond to orders, look it up yourself. You will indeed see that treatment "success" and "success group" are much more rigidly defined than the article implies.

"Jonas Salk would be interested to know that."

A ridiculous statement, comparing PCN's broad, uneven effectiveness against SOME forms of bacteria, versus this irresponsibly open-ended statement regarding what is in actuality a specific neuro-destructive condition at a specific stage in the disease process:

"About 95 percent of patients regain their sight after treatment".


33 posted on 08/06/2006 9:10:47 AM PDT by EyeGuy
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To: Badray; smokeyb; jim_g_goldwing

Interesting stuff ping.


34 posted on 08/06/2006 9:19:28 AM PDT by Conservative Goddess (Politiae legibus, non leges politiis, adaptandae)
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To: EyeGuy
There's a saying - "Dazzle 'em with daring; baffle 'em with bullsh*t."
You come under the heading of bullsh*t.
35 posted on 08/06/2006 9:33:27 AM PDT by oh8eleven (RVN '67-'68)
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To: oh8eleven

You are in over you head, way over your head, so you respond with the blanket bull$hit call.

You don't even have a clue as to how much you don't know.

Go disturb $hit elsewhere. I have better things to do.


36 posted on 08/06/2006 9:41:17 AM PDT by EyeGuy
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To: EyeGuy
You don't even have a clue as to how much you don't know.
Maybe so, but I know you're full of BS.
37 posted on 08/06/2006 10:07:33 AM PDT by oh8eleven (RVN '67-'68)
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To: Blue_Spark

"My Mom started treatments earlier this spring. First shot did not seem to do much. Since the second shot (in the eye) her vision has been getting better. I note that she is not needing the special fluorescent light to read now. So far, so good."

Glad to hear that. Very glad. Until it is lost, we do not realize how crucially important optimum central visual acuity is in EVERYTHING we do.

When was your mother first diagnosed with exudative ARMD?

More apropos, when did SHE first notice that her vision was functionally decreased?

When treatment was first initiated, did it seem to her that her vision was still in the process of declining?


Thanks in advance for your reply.


38 posted on 08/06/2006 10:14:05 AM PDT by EyeGuy
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To: Dark Skies

"About 95 percent of patients regain their sight after treatment, and in some, vision gradually gets better than it was before the onset of the disease."

This statement is incorrect if you go to www.fda.gov and read the original announcement. It should read that 95 percent MAINTAIN their current level of vision and about one third IMPROVE their current level of vision. Even so, this is a significant achievement and if the disease is caught early enough and treatment started, functional vision can be maintained.


39 posted on 08/06/2006 11:29:38 AM PDT by Kirkwood
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To: EyeGuy

She first noticed after laser surgury for skin cancer on her nose (abt 3yr ago? coincidence, who knows.) Diagnosis was a couple years ago as I recall.

If you know who is who, she is going to a retina specialist that covers the Pacific Northwest. I understand there is one other Dr. like him in LA. Fortunately he is 45min away. I've heard one patient came in from Montana as I was waiting during one appointment.

Also, as I recall, the retina Dr. did try a laser, to no avail.


40 posted on 08/06/2006 7:14:54 PM PDT by Blue_Spark
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To: mariabush

i am praying for some good news for you tomorrow.


41 posted on 08/06/2006 10:32:00 PM PDT by bitt ("And an angel still rides in the whirlwind and directs this storm.")
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To: Dark Skies
Some research is being done in animals using embryonic stem cells in the hope of being able to grow replacement tissue that will restore sight, but experts said clinical trials in humans are likely years away.

Typical know-nothing vermin. Try adult stem cells.

No cheers, unfortunately.

42 posted on 08/06/2006 10:48:40 PM PDT by grey_whiskers
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To: jdm
Your tagline did NOT go with your photo in post #20.

The photo is fine, please change the tagline.

Cheers!

43 posted on 08/06/2006 10:50:04 PM PDT by grey_whiskers
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To: bitt

Thanks, so much.

U am also having my evalation for my second catarac surgery .

Maria


44 posted on 08/07/2006 3:56:14 AM PDT by Coldwater Creek ("Over there, over there, We won't be back 'til it's over Over there.")
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To: mariabush; EyeGuy
This article hits home for me also. Not that I will benefit in any way, but the hope of treatment for sufferers.

I am 37 years old, and 2 weeks ago, I was diagnosed with normal tension open angle glaucoma. In my left eye I have already lost some sight, in my right eye, it seems to be in the preglaucoma stage. To say the least, for the past two weeks, my thoughts have been constantly on the idea of being blind in the coming years. So any hope for anyone is a plus to me.

45 posted on 08/07/2006 4:05:52 AM PDT by codercpc
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To: codercpc
My husband has had glacoma for many years. He is blind for the most part now. He can see light and some movement.

Medical technology is so good now, that if you will just do what the Dr. says and be really faithful with your meds, the prospect of having a long eyesight lifetime is great.

I don't know where you live, but get yourself to the best specialist that you you can find.
My husband is 71 and has had a host of other eye problems not glacoma related. So, you should be in good shape. One other thing, if you have children have them tested often as this is a hereditary disease. The good thing is that our children are in their forties and no sign.
If I can be of any help in any way feel free to freepmail me.
46 posted on 08/07/2006 4:50:28 AM PDT by Coldwater Creek ("Over there, over there, We won't be back 'til it's over Over there.")
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To: codercpc

Hopefully in your left eye you had only minimally lost peripheral vision. That is the case with many of my early glaucoma patients; we are able to arrest progression of the disease before additional peripheral vision is lost. The all important central vision is of course, in glaucoma the very last thing to be affected. It sounds like you are a LONG way from that happening.

These days, with timely and proper care it is rare for patients to lose their sight entirely from glaucoma. NTG formerly was somewhat of a more unusual diagnosis than it is today. Technology had advanced and has allowed us to obtain a much greater understanding of early damage to susceptible anatomy of the eye.

Obviously, I do not know the particulars of your case, but if you follow your doctor's instructions, chances are you will suffer no additional vision loss.

The post below yours suggests that you seek the best specialist you can find. Quite frankly, in the vast majority of cases, that is wholly unnecessary, as nearly all glaucoma cases can be efficiently and successfully managed by an optometrist or general ophthalmologist. A responsible doctor will certainly refer you for more specialized care if your case is a complicated one.

Best wishes on your future ocular health.


47 posted on 08/07/2006 5:23:10 AM PDT by EyeGuy
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To: mariabush

"Medical technology is so good now, that if you will just do what the Dr. says and be really faithful with your meds, the prospect of having a long eyesight lifetime is great."

That is absolutely correct.

We can thank God for some significant technological advances that have provided us much greater insight into early damage from the elevated pressure (or sometimes, so-called normal pressure), of glaucoma. These same technologies also allow us to much better MONITOR for progression of the disease.


48 posted on 08/07/2006 5:28:04 AM PDT by EyeGuy
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To: EyeGuy
Thank you for your reply, I am now medicated eye drops, and the advice you gave is almost identical to that of my optometrist. My NTG was diagnosed through the GtX? screening, and with no other risk factors, (including having normal IOP's) no family hx, etc. I am one of the lucky ones.

For all others Freepers reading this, please get screened. It takes only a few seconds, is not in anyway invasive, and is very inexpensive. It literally maps the thickness of your optic nerves and compares it to the rest of the population in your age, gender, and ethnic group. If it comes back normal, that's it, if not you then advance to other tests, and it could save your eyesight by catching it early.

49 posted on 08/07/2006 6:22:47 AM PDT by codercpc
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To: Dark Skies; All

While I have no doubt these drug therapies work for many people, I'm dismayed that so few doctors demand their patients with failing eyesight ALSO take vitamins A, C, E, amino-acid-chelated zinc, beta carotene and lutein. Some should also benefit from the herbs eyebright, bilberry, gotu kola, pycnogenol and possibly, grape seed extract.

D'oh! Almost forgot: American MDs have taken no more than 5 hours of nutrition classes in med school, if any at all, while they're subjected to dozens and dozens of presentations by pharma reps every year. I musta forgot to take my memory pills...


50 posted on 08/07/2006 8:03:03 PM PDT by FreeKeys ("Journalists almost always screw up science stories." -- Charley Reese)
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