Medical Policy



Subject: Intraocular Telescope
Document #: SURG.00136 Current Effective Date:    03/29/2017
Status: Reviewed Last Review Date:    02/02/2017

Description/Scope

This document addresses an intraocular telescope (Implantable Miniature TelescopeTM [IMT] [VisionCare Ophthalmic Technologies Inc., Saratoga, California]). The IMT is used to improve certain cases of severe to profound vision impairment caused by end-stage, age-related macular degeneration (AMD).

Position Statement

Medically Necessary:

An intraocular telescope (Implantable Miniature Telescope [IMT]) is considered medically necessary for monocular implantation to improve vision in individuals 65 years of age or older when all of the following criteria are met:

The individual must:

Investigational and Not Medically Necessary:

An intraocular telescope (Implantable Miniature Telescope [IMT]) is considered investigational and not medically necessary when all of the above criteria are not met.

Rationale

The U.S. Food and Drug Administration (FDA) approved the IMT in July, 2010 for monocular implantation to improve vision in individuals 75 years of age or older with stable, severe to profound vision impairment caused by bilateral central scotomas associated with end stage AMD. In October 2014, the FDA expanded the age limit for the IMT from 75 to 65 years of age or older.

Additionally, the FDA recommends that individuals:

The initial FDA approval was based on 1-year results of a prospective, open-label, multi-center clinical trial designed to evaluate the safety and efficacy of the IMT (Hudson, 2006). A total of 217 individuals, 55 to 93 years of age (mean age, 76 years) with AMD and moderate to profound bilateral central visual acuity loss (20/80 to 20/800) resulting from bilateral untreatable geographic atrophy, disciform scars, or both were enrolled. Eleven eyes did not receive the device because the procedure was terminated. The IMT was implanted monocular (in one eye) in the capsular bag after lens extraction. Fellow eyes were not implanted to allow for peripheral vision and served as controls. Study subjects participated in six visual rehabilitation visits after surgery. The majority of those subjects (90%) met or exceeded the visual acuity endpoint defined as an improvement in 2 lines or more in either near or distance best corrected visual acuity (BCVA) at the 1-year follow-up. Change in visual acuity was not related to lesion type. Mean quality-of-life scores from the National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) and the Activities of Daily Life scale, a secondary outcome measure, improved by more than 7 points from baseline on 7 of 8 relevant subscales (for example, social functioning, mental health, role difficulties, and dependency); at 12 months, 51.8 % (100/193) of those gained at least 5 points, 25.9% (50/193) of individuals reported no change (change within ± 5 points), and 22.3 % of those (43/193) lost at least 5 points in VFQ-25 composite score from baseline. Mean endothelial cell density (ECD) loss at 3 months was 20% and 25% at 12 months. The decrease in ECD was correlated with post-surgical edema, and there was no evidence that endothelial cell loss accelerated by ongoing endothelial trauma after implantation. The authors concluded that "the population of patients in this investigation experienced clinically meaningful and statistically significant improvements in both visual acuity and quality of life."

As a condition of approval, the FDA required the manufacturer, VisionCare Ophthalmic Technologies Inc. of Saratoga, Calif., to conduct two post-approval studies. In 2008, Hudson and colleagues reported results of follow-up evaluations continuing at 18 and 24 months. Main outcome measures included BCVA change from baseline, ECD and morphometry, and incidence of complications. Data from 174 (92.6%) of 188 available subjects were analyzed. Overall, 103 (59.5%) of 173 telescope-implanted eyes gained 3 lines or more (doubling of visual angle) of BCVA compared with 18 (10.3%) of 174 fellow control eyes (p<0.0001). Mean BCVA improved 3.6 lines (standard deviation [SD], 1.9 lines) and 2.8 lines (SD, 2.3 lines) from baseline in eyes with the 3X and 2.2X device models, respectively. Mean ECD stabilized through 2 years, with 2.4% mean cell loss occurring from 1 to 2 years. There was no significant change in coefficient of variation or percentage of hexagonal endothelial cells from within 6 months to 2 years after surgery. The most common complication was inflammatory deposits. Long-term results showed that the BCVA improvement demonstrated at 1 year was also maintained at 2 years.

A second post approval study (Boyer and colleagues, 2015) followed participants to 60 months and reported long-term safety and efficacy outcomes. Additionally explored was whether younger subjects had similar or better outcomes after IMT implantation as compared to the older participants. A total of 2 subgroup analyses were performed consisting of group 1 (n=70; subject age 65 to less than 75 years) and group 2 (n=127; subject age 75 years or older). The mean best corrected distance visual acuity (BCDVA) improvement from baseline to 60 months was 2.41 ± 2.69 lines in all subjects, with 2.64 ± 2.55 lines in group 1 and 2.09 ± 2.88 lines in group 2. At the 60-month final follow-up visit, 62% maintained a significant 2-line BCDVA improvement. Significantly higher quality of life scores and fewer adverse events were reported for group 1. Study limitations included a small number of participants as not all original participants chose to continue in the extension study. The authors also reported that for a small number of participants initially enrolled (n=20) but too small for inclusion in data analysis "the IMT performed as well in the 20 patients aged 55-65 years as in those aged 65-75 years."

Currently available evidence in the peer reviewed literature supports the use of the FDA approved intraocular telescope, IMT, in terms of clinical effectiveness and safety to improve severe to profound vision impairment caused by end-stage AMD when specific requirements are met.

Background/Overview

Age-related macular degeneration (AMD), a global disease that causes blindness, is becoming increasingly prevalent and has no effective cure (Jager, 2008). AMD affects the macula located in the center of the retina. The macula has the highest photoreceptor concentration and is where visual detail is discerned. Wet AMD occurs with the pathological formation of new blood vessels (angiogenesis) behind the retina. These new blood vessels often leak blood and fluid displacing the macula from its normal position at the back of the eye and distorting central vision as a result. Wet AMD is also known as advanced AMD.

The IMT is currently the only intraocular telescope system that is FDA approved (Singer, 2012). This device does not treat AMD directly; it works around the AMD. Incoming images are expanded onto the still functioning part of the macula. The device is about the size of a pea (3.6 mm diameter; 4.4 mm length) and is surgically inserted through an incision in the cornea, and rotated into place. The IMT has two mirrors that are used to enhance and magnify images. Although photoreceptors in the macular area are damaged by wet AMD, the peripheral photoreceptors remain intact. The purpose of the IMT is to magnify an image so that a much larger picture is projected onto the peripheral retina allowing the peripheral photoreceptors to pick it up so that the image can be seen by the individual. Only one eye can be implanted so that the other eye serves to pick up peripheral vision. Visual rehabilitation and occupational therapy are necessary to adapt to the device, therefore it is crucial that appropriate candidates are selected for the treatment. There are also concerns with side effects such as corneal edema, as well as the need for a corneal transplant (1 out of 25) due to damage caused by the IMT. However, for many age 65 years and older, IMT represents an opportunity to restore vision before it is lost completely.

Contraindications per product labeling information (2010):

Implantation of the intraocular telescope is contraindicated in individuals:

Warnings per product labeling information (2010) include the following:

Definitions

Age related macular degeneration (AMD): A disease blurring the sharp, central vision needed for "straight-ahead" activities such as reading, sewing, and driving. AMD affects the macula, the part of the eye used for fine detail. In some cases, AMD advances so slowly that people notice little change in their vision and in others, the disease progresses faster and may lead to a loss of vision in both eyes.

Central scotoma: An area of diminished vision corresponding with the point of fixation and interfering with central vision. More commonly known as a blind spot in the center of vision.

Choroidal neovascularization (CNV): A condition characterized by the development of new blood vessels across the back portion of the eye, which may interfere with vision.

Disciform scar: A subretinal scar, most often located in the macular area of the eye.

External telescope: A hand-held or externally worn telescope used to magnify objects.

Fovea: A pit in the retina of eye which allows for sharp central vision.

Geographic atrophy: Is considered late stage dry age related macular degeneration.

Peripheral vision: Vision outside the center of gaze, on the sides.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

CPT  
0308T Insertion of ocular telescope prosthesis including removal of crystalline lens or intraocular lens prosthesis
   
HCPCS  
C1840 Lens, intraocular (telescopic)
   
ICD-10 Procedure    
08RJ30Z Replacement of right lens with intraocular telescope, percutaneous approach  
08RK30Z Replacement of left lens with intraocular telescope, percutaneous approach  
     
ICD-10 Diagnosis    
H35.30 Unspecified macular degeneration  
H35.3110-H35.3194 Nonexudative age-related macular degeneration  
H35.3210-H35.3293 Exudative age-related macular degeneration  
H53.413 Scotoma involving central area, bilateral  

When services are Investigational and Not Medically Necessary:
For the procedure and diagnosis codes listed above when criteria are not met or for all other diagnoses not listed, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

References

Peer Reviewed Publications:

  1. Boyer D, Freund KB, Regillo C, et al. 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.
  2. Hudson HL, Lane SS, Heier JS, et al; IMT-002 Study Group. Implantable miniature telescope for the treatment of visual acuity loss resulting from end-stage age-related macular degeneration: 1-year results. Ophthalmology. 2006; 113(11):1987-2001.
  3. Hudson HL, Stulting RD, Heier JS, et al; IMT002 Study Group. Implantable telescope for end-stage age-related macular degeneration: long-term visual acuity and safety outcomes. Am J Ophthalmol. 2008; 146(5):664-673.
  4. Jager RD, Mieler WF, Miller JW. Age-related macular degeneration. N Engl J Med. 2008; 358(24):2606-2617.
  5. Singer MA, Amir N, Herro A, et al. Improving quality of life in patients with end-stage age-related macular degeneration: focus on miniature ocular implants. Clin Ophthalmol. 2012; 6:33-39.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. U.S. Food and Drug Administration. Center for Devices and Radiological Health (CDRH). Approval Order, Summary of Safety and Effectiveness, and Labeling: Implantable Miniature TelescopeTM . No. P050034. Rockville, MD: FDA. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P050034. Accessed on: December 30, 2016.
  2. U.S. Food and Drug Administration. Center for Devices and Radiological Health (CDRH). Premarket Approval (PMA) Datababase [P050034]. Supplement S015. Visioncare Implantable Miniature Telescope. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm. Accessed on December 30, 2016.
Websites for Additional Information
  1. National Eye Institute. U.S. National Institutes of Health. Facts About Age-Related Macular Degeneration. Last reviewed September 2015. Available at: https://nei.nih.gov/health/maculardegen . Accessed on December 30, 2016.
Index

CentraSight
Implantable Miniature Telescope (IMT)
Intraocular Implant
Intraocular Telescope
Ocular Telescope Prosthesis

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History
Status Date Action
Reviewed 02/02/2017 Medical Policy & Technology Assessment Committee (MPTAC) review. Rationale and Reference sections updated. Updated Coding section with 10/01/2016 ICD-10-CM diagnosis code changes.
Reviewed 02/04/2016 MPTAC review. Rationale and Reference sections updated.
  01/01/2016 Updated Coding section with 01/01/2016 CPT changes, revised descriptor for 0308T; removed ICD-9 codes.
Revised 02/05/2015 MPTAC review. Age limit in medically necessary statement expanded from age 75 to 65 years of age or over. Description, Rationale, Background, Coding and Reference sections updated.
Reviewed 02/13/2014 MPTAC review. Reference section updated.
New 02/14/2013 MPTAC review. Initial document development.