Surgical Management of Poor Vision from Macular Disorders
Bettersight welcomes the arrival of CentraSight®, a new treatment program using a tiny telescope that can be implanted inside the eye to improve vision and quality of life for patients with the most advanced form of macular degeneration – called ‘end stage AMD’.
CentraSight® is the only magnifying lens implant device approved by the US FDA (food and drug administration) and European C.E. approval at this point in time.
The CentraSight® treatment program uses a tiny telescope that is implanted inside the eye. The telescope implant, created from VisionCare Ophthalmic Technologies’ Implantable Telescope Technology, has been demonstrated to improve vision and quality of life for suitable individuals affected by End-Stage AMD. The tiny telescope – about the size of a pea – is implanted inside only one eye, behind the iris (the colored part of the eye). The implant is so small, it may be barely noticeable in your eye.
Technology Spotlight: ‘How It Works’
Once implanted inside the eye, the telescope projects images in your field of view onto healthy areas of your central retina outside of the degenerated macula. The image is enlarged, reducing the effect the blind spot has on central vision. Normally the healthy areas outside of the macula are used for peripheral or “side vision.” The magnification provided by the telescope implant (2.2X or 2.7X) makes it possible to see or discern the central vision object of interest.
What About the Other Eye?
End-Stage AMD affects detailed central vision in both eyes. It does not affect peripheral vision. Peripheral vision is low resolution (blurry). You can’t use it to read, but you can use it to detect objects and movement. In the CentraSight® treatment program, a person uses the eye with the telescope implant for detailed central vision (such as reading “WALK” signs at a zebra-crossing). The other eye is used for peripheral vision (such as checking to see if cars are coming from the side).
How Do I Use It?
The telescope implant does not limit your natural eye movements, and does not require you to move your entire head, as you have to do with external magnifying appliances. You can use natural eye movements to see things that are close and far away from you, such as reading printed materials or watching television. As a tradeoff to improving central vision, the peripheral (side) vision will be restricted in the eye with the telescope implant. However, your peripheral vision will stay the same as before the surgery in your non-implanted eye.
Is It Difficult to Use?
The brain is highly adaptable even at older ages. As a patient in the CentraSight® program, you will work with low vision specialists to develop the skills you need to use your new vision. One of the skills you need to learn is how to switch your viewing back and forth between the eye with the telescope implant and the eye without the implant. You will also need to wear eye glasses and may need to sometimes use a hand-held magnifier with the telescope-implanted eye to read or see fine details clearly. However, in general, less magnification will be needed after your surgery.
- Patient Assessment for Eligibility
If you are considered a possible candidate for the CentraSight® treatment program, you will be evaluated to see if you are likely to benefit from the telescope implantation surgical procedure and, if so, which eye is best suited for treatment. The evaluation includes a low vision consultation performed by a specially trained low vision optometrist.
The candidate evaluation includes testing your vision using external telescope simulators. The results of these tests can help give you and your CentraSight® team a good idea of what your vision may be like after the telescope implantation surgery and if the effect of the magnification in one eye will be useful to you. A low vision specialist will also talk to you about how your new vision status may affect your everyday life and how working with the low vision occupational therapist can help you reach your vision goals (for example, performing everyday tasks, self care, reading, and hobbies).
You may be considered a candidate for the CentraSight® treatment program if:
- Your vision improves while using an external telescope simulator
- You feel you can become accustomed to the difference in vision between your eyes
- There is a good chance of useful improvement in everyday activities and living
- Your vision goals are realistic and achievable
- You are willing and able to work with low vision specialists for visual training/rehabilitation after the eye surgery
- The Surgical Procedure
The telescope implantation surgical procedure is required for only one eye.
It involves removing the eye’s natural lens and replacing it with a tiny telescope implant. This part of the treatment process is done in a relatively short day case surgery and you will be expected to return home the same day.
The surgery involves several steps:
- Your eye is numbed at the beginning of the procedure so you don’t feel any pain.
- Eye drops will be administered to temporarily enlarge your pupil (as with cataract surgery)
- We can then remove the natural lens / cataract (a procedure identical to modern cataract surgery.
- The telescope prothesis will be placed in the same position where the natural lens was located
- The surgical incision will be resealed.
The surgical procedure will likely take around one hour.
- If there are complications during your surgery, your surgeon may not be able to finish the procedure. This means that you may undergo surgery, but not be able to receive the telescope implant and the potential benefits you could gain with it. If this is the case, your surgeon will attempt to implant a standard intra-ocular lens (IOL), as in any procedure for cataract removal.
Before the surgery, be sure to discuss any questions you might have with your surgeon. After surgery, you will have follow-up visits with your surgeon and eyedrops to take for several weeks.
- Learning to use your vision after CentraSight® Surgery
After you have recovered from surgery, specially trained low vision optometrists and occupational therapists will work with you to prescribe eyeglasses and complete your rehabilitation to help you adapt to and learn how to use your new vision (and way of seeing) in daily life. They will work with you on an individualised plan over several weeks to reach your personal goals. Within that plan basic skills you will learn include:
- Localizing: Locating an object of interest into the field of view of the telescope-implant eye
- Fixating: Focusing on an object in order to identify it
- Scanning: The natural eye movement performed by the telescope-implant eye
- Tracing: Following a path between two objects of interest
- Tracking: Following a moving object
- Navigating: Using your non-operated eye for non-central vision activities, like navigation (walking and getting around)
Learning these skills under the guidance of your low vision team and practicing them at home will help you to excel at using your new vision for everyday tasks and other activities that are important to you.
Realistic Goals with the Centrasight® treatment programme are :
- Recognising faces
- Watching TV
- Some reading may be possible – especially at larger print sizes
- Some hobbies such as painting, drawing, knitting or gardening may be possible
Unrealistic goals with the Centra-sight treatment programme are :
- Seeing a golf ball in flight
- Playing demanding sports such as tennis, badminton, squash etc.
- Never having to use a magnifying glass
- Benefits of Centrasight® treatment for end stage AMD
The effectiveness of the telescope implant has been demonstrated in FDA approved studies.
In results from a survey in the FDA clinical trial, patients who received the telescope implant generally reported:
- That they were less dependent on others
- They were less frustrated and worried about their vision
- They were less limited in their ability to see and
- They were better able to visit others and recognise facial expressions/reactions
- Overall, the survey findings showed patients had a clinically important improvement in their quality of life.1
An FDA study found that 90% (nine out of ten patients) with the telescope implant improved vision by at least two lines on the eye chart.
- What are the risks of CentraSight® treatment?
As with any medical intervention, potential risks and complications exist with the telescope implant.
The most common risks of the telescope surgery include inflammatory deposits on the device and increased pressure in the eye. Significant adverse events include corneal swelling which if severe and persistent may lead to a corneal transplant being required, and decrease in visual acuity.
There is a small risk that having the telescope implantation surgery could worsen vision rather than improve it. As with any treatment individual results can and do vary.
As much as possible at Bettersight we will endeavour to provide a detailed, individualised perspective on both the potential benefits and the potential risks of the Centrasight surgical treatment programme.
Additional information can be found at www.en.CentraSight.com.
- FAQ's on CentraSight® and End Stage AMD
The following frequently asked questions provide information on End-Stage AMD, the most advanced form of age-related macular degeneration (AMD), and the CentraSight treatment program.
It is important to understand that the telescope implant does not reverse or stop End-Stage AMD. It is intended to improve vision and quality of life for people with End-Stage AMD.
What is AMD (age-related macular degeneration)?
AMD is a condition of the eye that affects the central retina, or macula, located in the back of the eye. There are two forms of AMD: the “wet” form and the “dry” form. The “wet” form of the disease can cause fluid and blood to leak onto the macula. In the “dry” form, the macula breaks down without any leakage of fluid. Both forms cause the macula to degenerate and can lead to End-Stage AMD in which there is significant permanent central vision loss.
How does AMD affect vision?
The macula is important to eyesight since it is the part of the eye responsible for detailed central or “straight ahead” vision. Although people with AMD rarely go completely blind because of this condition, they may find it difficult to read, recognize faces or colors, drive, and perform other everyday functions that require central vision.
What form of AMD can the telescope implant help?
The telescope implant is indicated for eligible patients who have End-Stage AMD, the most advanced form of AMD. Your ophthalmologist can tell you if you have End-Stage AMD.
How is End-Stage AMD different from earlier or milder forms of AMD?
In End-Stage AMD, the macula is degenerated in both eyes without any healthy macular areas left for detailed central vision. For the patient, there is no way to see around the central blind spot in their vision. In earlier or milder forms of AMD, visual symptoms may be minor and not necessarily impacting the individual’s ability to easily perform daily activities. Also, in less advanced forms of AMD, one eye may still have central vision or, in the case of wet AMD, drug treatments may help stabilize vision or offer some improvement.
How does the CentraSight® treatment program help patients with End-Stage AMD?
The CentraSight® treatment program uses a tiny telescope that is implanted inside the eye. The telescope implant is an FDA-approved medical device that works like a telephoto lens of a camera. Once implanted inside the eye, it magnifies images onto the healthy areas of the light-sensing retina to help improve central (straight ahead) vision.
What does the telescope look like in the eye? Can others see it?
The telescope is virtually unnoticeable to others because it is implanted totally inside the eye, and mostly covered by the colored portion of the eye (iris).
Are there other medical treatments available?
Unfortunately, there currently are no medical treatments available for patients with End-Stage AMD. External appliances worn outside the eye are used by some patients with End-Stage AMD in an attempt to improve vision, but these devices have quite severe practical limitations.
Does insurance cover the telescope implant?
No – however insurance funding may cover a small portion of the costs related to the removal of the cataract. Unfortunately at present neither the NHS nor insurance companies will fund this treatment fully at this stage.
What are clinical trials?
A clinical trial is a study to test the safety and effectiveness of a new drug or medical device in patients. A doctor supervises the research and follows a clinical protocol or study plan. Studies of new medical devices or new drugs also require approval of the U.S. Food and Drug Administration (F.D.A.). Over 200 patients were studied in FDA clinical trials prior to approval of the telescope implant used in the CentraSight treatment program
Risks and Benefits of Centrasight® treatment programme for end stage AMD.
Some common questions about Centrasight®
If you would like to consider a consultation to assess your suitability for the CentraSight® program please click below to be directed to the appointment request page.