How Effective is the Telescope Implant?

The effectiveness of the telescope implant has been demonstrated in clinical trials. The main study to assess the effectiveness and safety of the implant involved 28 leading ophthalmic centers located throughout the U.S. The results have been published in top-tier medical journals.^(1,2)

Improved Vision

The clinical study enrolled over 200 patients and demonstrated that they were able to see on average three to four lines better on the eye chart after telescope implantation. For some patients, this improvement could make the difference between being able or not being able to recognize a friend or facial expressions. The CentraSight treatment program, or any other treatment for that matter, cannot fully restore vision to levels a person enjoyed before the permanent macular degeneration developed. However, nine out of every ten patients with the telescope implant improved vision enough to meet or exceed the FDA study's effectiveness endpoint - a clinically important improvement of distance or near vision by at least 2 lines on the eye chart.

In the FDA clinical trial, at least 50% of telescope implanted eyes were required to improve ≥ 2 lines of distance or near visual acuity. In the trial, 90.1% of patients achieved this level of improvement.

Improved Quality of Life

Patients in the clinical trial also reported improved quality of life, as assessed by a commonly used scientific patient survey on the impact of eye disease - the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25).

On this survey, patients assessed their disability and difficulties due to their vision both before and after the telescope implant surgery. Patients reported what level of difficulty they had with activities such as distance and near vision tasks, as well as other areas like independence and social function. Examples of questions include:

• How much difficulty do you have:
  • reading street signs or names of stores?
  • seeing how people react to things you say?
  • visiting with people in their homes, parties, or in restaurants?
  • going out to see movies, plays, or sporting events?
• How true are the following statements as they apply to you?
  • Because of my eyesight, I have to rely too much on what other people tell me.
  • I worry about doing things that will embarrass myself or others because of my eyesight.

In results from this survey in the FDA clinical trial, patients who received the telescope implant generally reported that they were less dependent on others, less frustrated and worried about their vision, less limited in their ability to see, and better able to visit with others and recognize facial expression/reactions. The areas that showed the greatest improvement were related to general vision, near activities, and dependency and areas with the least improvement or decline were color vision and peripheral vision. Overall, the survey findings showed patients had a clinically important improvement in quality of life.⁽²⁾

Safety

The most common risks of the telescope implantation surgery include inflammatory deposits or precipitates on the device and increased intraocular pressure. Significant adverse events include corneal edema, corneal decompensation, corneal transplant, and decrease in visual acuity. There is a risk that having the telescope implantation surgery could worsen your vision rather than improve it. Individual results may vary. These are not all the risks of telescope implantation surgery. More detailed safety information can found on the Important Safety Information page.

You should ask your doctor about all the potential risks and benefits of telescope implantation.

References

1. Hudson HL, Stulting RD, Heier JS, Lane SS, Chang DF, Singerman LJ, Bradford CA, Leonard RE. IMT002 Study Group. Implantable Telescope for End-Stage Age-Related Macular Degeneration. Long-Term Visual Acuity and Safety Outcomes. Am J Ophthalmol. 2008;146:664-673.

2. Hudson HL, Lane SS, Heier JS, Stulting RD, Singerman L, Lichter PR, Sternberg P, Chang DF. Implantable miniature telescope for the treatment of visual acuity loss due to end-stage age-related macular degeneration: one year results. Ophthalmology. 2006;113:1987-2001.