PHILADELPHIA (Ivanhoe Newswire) - They happen when fibers in the eye pull away and tear the retina. Macular holes can threaten vision and force people to go under the knife to save their sight. While surgery used to be their only option, something new is giving patients a first of its kind alternative.
While cruising the Caribbean, Catherine Brown realized what she thought had been a problem with her TV, was actually a problem with her eyes.
"It just wasn't going away and I couldn't blame the television anymore. It was me. It was clearly me," Catherine Brown, who had macular holes, told Ivanhoe.
She had macular holes, small breaks in the center of the retina that cause blind spots and visual distortions.
"They notice that it's almost like a fun house mirror effect sometimes when they look at people," Julia A. Haller, MD, Ophthalmologist-in-Chief at the Wills Eye Institute, told Ivanhoe.
"It was unbelievable," Brown said.
In the past the only option for patients was surgery, but Dr. Julia Haller said a drug recently approved by the FDA could help them avoid it.
"It's really, it's miraculous," Dr. Haller said.
Jetrea is injected directly into the eye. It basically breaks down proteins that cause the condition. Two clinical studies showed the drug closed macular holes in 26-percent of participants. That's one in four patients who didn't need surgery.
"It's like night and day. Within a few days your symptoms are gone. You've got recovery of vision," Dr. Haller explained.
"It was phenomenal that, um, I released as quickly as I did," Brown said.
Catherine's macular holes are healed. Now, this church pianist doesn't have to pray for a miracle.
The most common side effects of Jetrea are blurry vision and eye floaters. Researchers hope the drug could one day be used to treat other common eye conditions, like macular degeneration and diabetes-related eye issues. Clinical trials to test the drug on those conditions are in the works.
BACKGROUND: A macular hole is a small break in the macula, the center of the eye's light-sensitive tissue called the retina. The macula is responsible for providing the central vision we need for seeing fine detail, like reading, or driving. A macular hole will cause blurred and distorted central vision, but they begin gradually. In the early stage, people might notice a slight distortion or blurriness when they look directly in front of them. Objects and straight lines may begin to look wavy. Reading and performing other routine tasks with the affected eye becomes difficult. There are three stages to a macular hole: stage 1 (foveal detachments), stage 2 (partial-thickness holes), and stage 3 (full-thickness holes). During stage 1, if left untreated about half of stage 1 macular hole will progress. In stage 2, if untreated 70 percent of holes will progress. When a stage 3 macular hole develops, most central and detailed vision can be lost. If left untreated, a stage 3 macular hole can lead to a detached retina. (Source:http://www.nei.nih.gov/health/macularhole/macularhole.asp)
CAUSES AND RISKS: Eighty-percent of the eye is filled with a gel-like substance that helps it maintain a round shape, called vitreous. It contains millions of tiny fibers that are attached to the surface of the retina and as we age the vitreous shrinks and pulls away from the retinal surface. Natural fluids will fill the area where the vitreous has contracted. In most cases, there are no adverse effects. Some patients may experience an increase in floaters, or "cobwebs," that seem to float in the field of vision. If the vitreous is firmly attached to the retina when it pulls away, it can tear the retina and create a macular hole. In addition, once the vitreous has pulled away from the surface of the retina, some of the fibers can remain on the retinal surface and can contract. This will increase tension on the retina and lead to a macular hole. Macular holes can also occur in other eye disorders, such as injury to the eye, retinal detachment, high myopia, and rarely, macular pucker. (Source:http://www.nei.nih.gov/health/macularhole/macularhole.asp)
TREATMENT: Some macular holes can seal themselves and do not require treatment. Surgery is necessary in many cases to improve vision. It is called vitrectomy, the vitreous gel is removed and replaced with a bubble containing a mixture of air and gas. The bubble acts as a temporary, internal bandage that holds the edge of the macular hole in place as it heals. The surgery is done under local anesthesia and often on an out-patient basis. (Source:http://www.nei.nih.gov/health/macularhole/macularhole.asp)
NEW TECHNOLOGY: In October, 2012 JETREA, an example of a preparation of ocriplasmin, was FDA approved for patients diagnosed with Vitreo Macular Adhesion (VMA). It is the first nonsurgical alternative to eye surgery for this problem. Instead of undergoing surgery, the patient gets their eye numbed. Then the drug is injected into the eye. The medicine dissolves adhesions that cause the problem in the focus point of the eye. For small holes, it works 50 percent of the time. During clinical trials, 652 eyes were treated: 464 with ocriplasmin and 188 with placebo. Vitreo Macular Adhesion resolved it in 26.5 percent of ocriplasmin-injected eyes and in 10.1 percent of placebo-injected eyes. Total posterior vitreous detachment was more prevalent among the eyes treated with ocriplasmin (13.4 percent) than among those injected with placebo (3.7 percent). Nonsurgical closure of macular holes was achieved in 40.6 percent of ocriplasmin-injected eyes, as compared to 10.6 percent of placebo-injected eyes. The best-corrected visual acuity was likely to improve by a gain of at least three lines on the eye chart with ocriplasmin than with placebo. Intravitreal injection closed macular holes in significantly more patients than the injection of placebo. (Source: http://www.nejm.org/doi/full/10.1056/NEJMoa1110823)
Julia Haller, MD, ophthalmologist-in-chief at the Wills Eye Hospital, talks about a new therapy for macular holes.
Can you explain what the drug for macular holes is?
Dr. Haller: The drug, Ocriplasmin, acts on the vitreous gel and its attachment to the retina. The vitreous gel fills the back part of the eye and it is adherent to the retina. The retina is the tissue in the back of the eye that acts like the film in a camera. That is what actually takes the picture when the light gets focused on it. The macula is the center part of the retina. It's the part that you use to recognize faces, read, and see street signs; the central part of your visual field.
How does a macular hole form?
Dr. Haller: As the eye ages, the vitreous gel that fills the central space gets more liquid and it gradually peels away from the retina. That is called a posterior vitreous detachment. That happens in everybody. In most people it is somewhere after the age of 60 or so. In some people, as it is peeling away, it pulls on the retina and it can distort it and cause swelling. In the extreme example, it can actually pull a tiny hole in the central retina and then you're missing part of that central visual field.
That can lead to blurry vision?
Dr. Haller: The traction on the central macula leads to distortion, blurry vision, small areas of missing visual field, and if you actually get a macular hole, you are completely blind in that central area where you no longer have any functioning retinal tissue.
Is this the area that helps you with recognizing faces, colors, your visual acuity; all those things?
Dr. Haller: Yes, exactly right. So, the person who this is happening to starts to notice that something is not quite right when they look around. They have trouble reading. They may notice that lines start to look wavy. They may notice that they cannot follow along when they are trying to read the paper or read a book. They cannot read signs. They notice that it is almost like a funhouse mirror effect. Sometimes when they look at people lines will bend in and people's faces will look like an hourglass.
Before this, surgery was the only option?
Dr. Haller: Exactly. In the past, the only option we had for these patients was surgery. As a result, we would wait until things got bad enough that it was worth the risk of an operation before doing surgery. Sometimes people would have permanent loss of vision and they would not be able to regain it completely because we waited until it was bad enough to be worth going to the operating room.
So, now you have this new medication that can be injected into the eye?
Dr. Haller: Precisely. It is a drug that is injected into the eye in the office. It is an outpatient procedure. We do many of these injections for other reasons. Injections in the eye are a common treatment for macular degeneration and diabetic eye disease. In this particular case, the patient gets a single injection. Then they start to notice some floaters, maybe some flashing lights as the vitreous gel peels away. In up to 40 percent of cases, for example of macular holes, the hole will close without any surgery.
So it is a lot less invasive. Do they still need to lay flat like they do with surgery?
Dr. Haller: No. That is one of the huge advantages particularly for macular hole patients because those patients normally not only are having an operation, but their eye is filled with a temporary gas bubble and they have to actually keep their head down so that the bubble pushes up against the edges of the hole and that means that they have got to have face-down positioning. Of course they have the normal postoperative medications and they have up to a month or so where they cannot fly in an airplane. They have severe motility restrictions as well as the standard risks of any operation, such as bleeding, infection, retinal detachment, and virtually everybody gets cataract progression as well as a cataract operation.
How does that compare then with the new medicine?
Dr. Haller: It is like night and day. Within a few days, your symptoms are gone. You have got recovery of vision. You have none of the risks of surgery, none of the postoperative positioning requirements or medications, far less expense, far less inconvenience, and far less down time. It is really miraculous.
So you don't have to worry about cataracts and you don't have to worry about being facedown?
Dr. Haller: Exactly. That inconvenience and side effect is a deal breaker for some people. They decide they are just going to live with really no functional central vision in one eye rather than have surgery. It is paradigm shifting for us. It is something that the ophthalmology community and particularly retina specialists are very excited about.
It does not prevent cataract?
Dr. Haller: It prevents the type of cataract that develops after retinal surgery, because you don't have to have retinal surgery. You don't have the cataract surgery that you inevitably would need following the macular hole operation.
So, the majority of people would be interested in this if they are aging or near sighted?
Dr. Haller: Yes. The population that this would apply to is people who are developing this aging process in the vitreous. It tends to be people who are in their 50s, 60s, 70s, and older. Women, more than men, get macular holes. It is more common in people who are near sighted than in people who do not need to wear glasses for distance vision. It is potentially applicable to a host of other even more common diseases, but we have to test them. So, there is some thought that it may be valuable even in diseases as common as macular degeneration and diabetic retinopathy, but, that remains to be seen. There is a lot more work to be done. It is a very exciting new drug and we think it may be applicable to a lot more diseases. For example, in diabetics, the most severe blinding complication of diabetes is when you have abnormal blood vessels that grow up out of the retina and they grow onto the back of the vitreous gel. The vitreous gel serves as a scaffold for them to grow. So, if you could remove that scaffold, there would be nothing for them to grow on. Potentially, you could save that most complicating and blinding form of diabetic disease from happening. Now, that has not been proven yet. It's just a potential application, but that is one we are very excited about.
With this drug you can catch it early, instead of having to wait until they are nearly blind like they would do with the surgery?
Dr. Haller: Exactly. We know that if you operate at an earlier stage patients do better, but they also incur the risk at an earlier stage. So potentially as soon as people start to become symptomatic and have problems, we can offer them this as an alternative to surgery, a pharmacologic surgery and then they do not need to go onto an actual operation.
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