Clinical Trials Outcomes: Use of the Implantable Miniature Telescope (by Dr. Isaac Lipshitz) for Treatment of Late-Stage Age-Related Macular Degeneration
The effectiveness of the telescope implant for the treatment of Late-Stage Age-Related Macular Degeneration 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).
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Clinical Finding: Improved Vision
The clinical study was conducted as part of the U.S. Food and Drug Administration’s (FDA) approval process. The study enrolled over 200 patients with End-Stage Age-Related Macular Degeneration and demonstrated that they were able to see on average three to four lines better on the eye chart after IMT 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 IMT 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.
Clinical Finding: Improved Quality of Life
Late-Stage Age-Related Macular Degeneration 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.
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 and peripheral vision. Overall, the survey findings showed patients had a clinically important improvement in their quality of life (2).
Clinical Finding: Visual Gains Are Long-lasting
A study published in the peer-reviewed journal, Clinical Ophthalmology, demonstrated that after 60 months (5 years) of follow-up, IMT patients had substantial retention of gains in visual acuity over time after implantation. Overall, data showed that there was a clinically significant gain in visual acuity (mean 3.2 lines of gain on visual charts) at 2 years after telescope implantation and most of the gain in visual acuity was maintained (mean 2.4 line improvement) at five years after telescope implantation. Retention of the clinically significant 2-line visual acuity gain was somewhat higher in younger patients as compared to older study participants (68% versus 59%, respectively) at the conclusion of the five-year study.
With respect to adverse events, only 7% of patients, at their last study exam, had visual acuity loss of more than 2 lines in telescope implanted eyes. Visual acuity loss was somewhat higher in older patients than younger patients (8% versus 6%). In younger and older groups two patients in each group underwent corneal transplant (2% and 3%, respectively). Overall, adverse events were somewhat higher in the older group of patients. (3)
Important Safety Information
The most common risks of the telescope implantation procedure include inflammatory deposits or precipitates on the device and increased intraocular pressure. Significant adverse events include corneal edema, vision-impairing corneal edema, corneal transplant, and a decrease in visual acuity. There is a risk that having the telescope implantation procedure 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 be found on the Important Safety Information page.
You should ask your doctor about all the potential risks and benefits of the telescope implantation procedure.
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. . 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. . 2006;113:1987-2001.
3.Boyer D, Freund KB, Regillo C, Levy MH, Garg S. Long-term (60-month) results for the implantable miniature telescope: efficacy and safety outcomes stratified by age in patients with end-stage age-related macular degeneration. Clin Ophthalmol. 2015;9:1099-1107. Published 2015 Jun 17. doi:10.2147/OPTH.S86208
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