The implantable miniature macular degeneration telescope developed by CentraSight received FDA approval as of July 2010. The device helps to improve vision for those who have advanced macular degeneration or end-stage macular degeneration in which there is severe loss of one's central vision. In end-stage AMD the damage to the retina's macula is permanent and there is no medical drug that can treat it.
Research for the retina implant began in 2006 at 28 eye centers in the United States. Well known eye centers like Wilmer Ophthalmological Institute in Baltimore, Maryland and Emory Eye Center in Atlanta were some of the study sites.
Over 200 patients participated in the study. The telescope has already been approved for use in Europe and has the Health Canada Listing. Patients have experienced improved vision and improved quality of life.
The implant does not restore lost vision to normal vision but does restore some of the lost central vision. Patients are able to see things they were not able to see before such as faces and writing in books or magazines.
The FDA website reports these results:
"In a 219-patient, multi-center clinical study of the Implantable Macular Degeneration Telescope, 90 percent of patients achieved at least a 2-line gain in either their distance or best-corrected visual acuity, and 75 percent of patients improved their level of vision from severe or profound impairment to moderate impairment."
The FDA approved implantable telescope is placed into the eye with the poorest vision. The telescope actually replaces the existing lens and magnifies images 2.5x. The effect of the magnification of an image decreases the blind spot that is located in one's central vision.
Cornea and cataract eye specialists who are specially trained perform the implant procedure.
It is approximately a one hour out patient procedure. "It absolutely functions as a telescope," said Kathryn Colby, MD, of Massachusetts Eye and Ear Infirmary. "It has two wide-angle, high-power lenses. They are just very, very small."
Very small indeed, the device is about the size of a pea. The macular degeneration telescope works by directing light from the new lens to parts of the macula that are still functioning. Patients first try an external version of the telescope to see how it works for them.
It's not all over once the implant is in place. Training by a low vision specialist is necessary to teach the patient how to coordinate their vision - with one eye having central vision and the other eye peripheral vision - before and after the implant.
Not everyone with macular degeneration is eligible for the telescopic implant. This is not an all inclusive list. There are other requirements besides the ones listed here. They are:
1. Have irreversible, end-stage AMD resulting from either dry or wet AMD
2. Are no longer a candidate for drug treatment for your AMD
3. Meet age, vision, and cornea health requirements (As of December 2014 the age requirement is 65 and older)
4. No active bleeding or treatment for choroidal neovascularization within the last 6 months
5. No uncontrolled glaucoma
6. No history of retinal detachment
7. No previous intraocular, corneal or refractive surgery in the implantable eye
8. Have not had cataract surgery in the eye in which the telescope will be implanted
Currently any patient with end stage AMD needing the implant in the eye that has had cataract surgery has been ineligible for this procedure. However many patients with macular degeneration have had cataract surgery to help improve their vision some with disappointing results.
“Cataract surgery is often performed on patients living with macular degeneration in the hopes that an IOL will improve contrast and light. However, studies show that patients who progress to End-Stage macular degeneration do not experience an appreciable improvement in their visual acuity, post cataract surgery,” said Stephen Lane, MD. “The long term efficacy of the telescope implant in improving vision and quality of life in AMD patients has been demonstrated during studies that followed subjects up to 8 years post-surgery. This study will inform us about the safety, effectiveness, and the appropriate surgical technique for implanting the telescope in patients who have had cataract surgery before.”
On January 10, 2017 the FDA granted VisionCare, Inc. approval to begin a clinical study on the use of the CentraSight implant in patients who have had cataract surgery. The clinical trial will begin by evaluating the safety and effectiveness of the telescope/retina implant in patients who have previous cataract surgery with an intraocular lens (IOL). The IOL will be removed and replaced with the implantable miniature telescope by Dr. Isaac Lipshitz.
There are now several CentraSight providers in the US who are seeking to enroll patients with end-stage macular degeneration who have had cataract surgery to see if they might be candidates for the Telescope Exchange Study.
To find out more you may call CentraSight and speak to a representative at 1-877-997-4448.
Deposits on the device and increased intraocular pressure are the most common side effects.
According to the FDA website,"Because the IMT is a large device,
implantation can lead to extensive loss of corneal endothelial cells
(ECD), the layer of cells essential for maintaining the clarity of the
cornea, and chronic endothelial cell loss.
The chronic rate of endothelial cell loss is about 5 percent per year. Significant losses in ECD may lead to corneal edema, corneal decompensation, and the need for corneal transplant.
In the study, 10 eyes had unresolved corneal edema, with five resulting in corneal transplants.
The calculated five-year risk for unresolved corneal edema, corneal decompensation, and corneal transplant are 9.2 percent, 6.8 percent and 4.1 percent, respectively."
Again the procedure is performed in only one eye. The eye's natural lens is removed and replaced with a tiny telescope implant.
It is a relatively short out-patient procedure that starts with numbing the eye and administering special eye drops to enlarge the pupil. A speculum, a special instrument, holds the eye open while the surgeon removes the natural lens.
The miniature telescope is then placed where the natural lens was located. Sutures are used to close the surgical incision.
All patients who received the implantable device who were enrolled in the IMT-002 trial were asked to participate in a 5 year follow-up study. This study will monitor long-term safety.
Patients will be examined at six-month intervals up to a total of 5 years following implantation.
They will be monitored for possible complications such as rates of corneal transplant, retinal detachments and corneal edema.
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