Clinical Safety and Efficacy Data

U.S. Clinical Studies

Two multi-year clinical studies have been conducted to evaluate the safety and efficacy of the Implantable Miniature Telescope : the IMT-002 pivotal safety and efficacy study and the IMT-002-LTM long-term monitoring safety study.(1)

Pivotal Study

The 2-year, prospective, 28-center IMT-002 pivotal study (n=217) evaluated the safety and effectiveness of the telescope prosthesis for the improvement of visual acuity in patients with bilateral moderate to profound central vision impairment (best corrected distance visual acuity (BCDVA) between 20/80 and 20/800) due to untreatable End-Stage Age-Related macular degeneration (AMD).(2)

Efficacy Results

The IMT prosthesis improved visual acuity and quality of life in subjects with End-Stage AMD. The primary effectiveness endpoint, a 2-line or greater gain in either distance or near best corrected visual acuity (BCVA) at 12 months in at least 50% of study subjects, was met and exceeded. The secondary effectiveness outcome measure, improvement in quality of life, was also improved by clinically significant levels.

Ninety percent of IMT-implanted eyes achieved at least a 2-line or greater gain in either distance or near BCVA at 12 months, thus exceeding the 50% criterion specified for the primary endpoint. This criterion was also exceeded at 24 months.

At least 50% of IMT-implanted eyes were required to improve ≥ 2 lines of best-corrected distance or near visual acuity (BCDVA or BCNVA). In the study, 90.1% of patients achieved this level of improvement.

Long-term follow up data from the IMT-002-LTM study demonstrated mean BCDVA improvements were generally retained at 36 and 48 months in telescope-implanted eyes. Mean BCDVA was maintained between 12 and 48 months, with BCDVA at 48 months within 2 line of BCDVA at 12 months.

Clinically meaningful visual acuity benefit demonstrated through 2-year follow up. 60% of patients gained better than 3 lines of best-corrected distance visual acuity (BCVA).

Quality of life, as assessed by the National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25), was a secondary outcome measure. The VFQ-25 is a validated version of the National Eye Institute Visual Functioning Questionnaire (VFQ) which measures vision-targeted health status for persons with chronic eye diseases including macular degeneration. A 5-point difference in subscale and/or composite scores may be interpreted as clinically significant.(3-5) The VFQ-25 survey was administered at baseline and postoperatively. The results demonstrate that implantation with the IMT improved quality of life in this study population (subjects with End-Stage AMD and significant bilateral vision impairment). The mean overall composite score, as well as the scores for almost all relevant subscales, achieved a clinically significant level. Not only was there an improvement in vision-specific subscales, which would be expected with a doubling of visual acuity, there was also a significant improvement on the psychosocial vision-targeted dependency, mental health, role difficulties, and social functioning subscales. Results suggest that patients are less dependent on others, less worried or frustrated with their visual acuity, less limited in their activities related to visual acuity, more able to visit with others, and better able to recognize facial expressions.(1)

A total of 217 subjects were evaluated in the IMT-002 clinical trial. A total of 206 eyes were implanted with the telescope prosthesis and followed for 24 months. 129 patients were enrolled in the IMT-002-LTM long-term monitoring trial for which 4-year safety data was available.

Ocular complications encountered during the studies included endothelial cell loss, inflammatory/pigment deposits, transient cornea edema, and IOP elevation.

Professional Use Information and Long-Term Monitoring Data

Full prescribing information, safety and efficacy data, and long-term monitoring data after telescope implantation are available in the Professional Use Information.

Document Name Language Download
SING IMT™ Instructions For Use (EU)
User Information - SING IMT™ Device Labeling (EU)
External Telescope Simulator User’s Guide (For Professional Use)
User Information - ETS Device Labeling (EU)
WA-IMT Professional Use Information (USA)

Clinical References and Related Publications

The following are referenced peer-reviewed scientific articles related to the telescope prosthesis U.S. clinical trials and other publications of interest related to the Samsara Vision Patient Journey for Age-Related Macular Degeneration (AMD) and its IMT Technology.

  1. 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.
  2. 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.
  3. Submacular Surgery Trials Research Group. Evaluation of minimum clinically meaningful changes in scores on the National Eye Institute Visual Function Questionnaire (NEIVFQ) SST Report No. 19. Ophthalmic Epidemiaol. 2007;14:205-215.
  4. Globe DR, Wu J, Azen SP, et al. The impact of visual impairment on self-reported visual functioning in Latinos. The Los Angeles Latino Eye Study. Ophthalmology. 2004;111:1141-9.
  5. Submacular Surgery Trials Research Group. Responsiveness of the National Eye Institute Visual Function Questionnaire to changes in visual acuity: findings in patients with subfovealchoroidal neovascularization-SST report no. 1. Arch Ophthalmol. 2003;121:531-9.
  6. Colby KA, Chang DF, Stulting RD, Lane SS. Surgical placement of an optical prosthetic device for end-stage macular degeneration: The Implantable Miniature Telescope. Arch Ophthamol. 2007;125:1118-21.
  7. la Cour M, Kiilgaard JF, Nissen MH. Age-Related macular degeneration: epidemiology and optimal treatment. Drugs Aging. 2002;19(2):101-33.
  8. Bourne WM, Nelson LR, Hodge DO. Central corneal endothelial cell changes over a ten-year period. Invest Ophthalmol Vis Sci. 1997;38:779-782.
  9. Armitage W, Dick A, Bourne W. Predicting Endothelial Cell Loss and Long-Term Corneal Graft Survival. Inv Ophthalmol Vis Sci. 2003;44:3326-31.
  10. Implantable Miniature Telescope (by Dr. Isaac Lipshitz) Professional Use Information. VisionCare Ophthalmic Technologies, Inc., Saratoga, CA. 2010.
  1. Chun DW, Heier JS, Raizman MB. Visual prosthetic device for bilateral end-stage macular degeneration. Expert Rev Med Devices. 2005;2:657-65.
  2. Garfinkel RA,Berinstein DM, Frantz R. Treatment of choroidal neovascularization through the implantable miniature telescope. Am J Ophthalmol. 2006;141:766-7.
  3. Lane SS, Kuppermann BD. The Implantable Miniature Telescope for macular degeneration. Curr Opin Ophthalmol. 2006;17:94-8.
  4. Lane SS, Kuppermann BD, Fine IH, Hamill MB, Gordon JF, Chuck RS, Hoffman RS, Packer M, Koch DD. A prospective multicenter trial to evaluate the safety and effectiveness of the implantable miniature telescope. Am J Ophthalmol. 2004;137:993-1001.
  5. Peli E. The optical functional advantages of an intraocular low-vision telescope. Optom Vis Sci. 2002;79:225-33.
  6. Primo SA. Implantable miniature telescope: lessons learned. Optometry. 2010; 81:86-93
  7. Singer MA, Del Cid MR, Stelton CR, Boord T. Pars plana capsulotomy in a patient with a telescope prosthesis for Age-Related macular degeneration. Arch Ophthalmol. 2010;128