Pending Policies - Surgery


Intraocular Lens (IOLs) and Implantable Miniature Telescope (IMT)

Number:SUR713.025

Effective Date:01-01-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Intraocular Lens

Monofocal (both aspherical and spherical) intraocular lenses (IOLs) may be considered medically necessary when used to replace the natural crystalline lens of the eye when the natural lens becomes cataractous.

Toric, multifocal, and/or accommodating are considered not medically necessary.

Implantable Miniature Telescope (IMT)

The Implantable Miniature Telescope™ (IMT) may be considered medically necessary for monocular implantation when the following criteria are met:

1. Patient is 65 years or older with stable severe to profound vision impairment caused by blind spots (bilateral central scotoma) associated with untreatable end-stage AMD (age-related macular degeneration); AND

2. Patient has evidence of a visually significant cataract (grade 2 or higher); AND

3. Visual acuity is poorer than 20/160, but not worse than 20/800 in both eyes; AND

4. Patient has undergone training with an external telescope prior to implantation and has been determined to have adequate improvement in vision, and adequate peripheral vision in the eye that would not be implanted; AND

5. Patient can achieve at least a 5-letter improvement on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart in the affected eye using an external telescope.

NOTE 1: Patient should undergo postoperative training with a low vision specialist after IMT implantation.

NOTE 2: Patient should complete the Acceptance of Risk and Informed Decision Agreement prior to IMT implantation. (Because the IMT is a large device, implantation can lead to extensive loss of corneal endothelial cells. Significant losses in corneal endothelial cells may lead to corneal edema, corneal decompensation, and the need for corneal transplant. To ensure that the risks of IMT implantation are consistently communicated to patients, the Food and Drug Administration and the manufacturer created detailed labeling that includes an Acceptance of Risk and Informed Decision Agreement.)

Description:

Intraocular Lens

Presbyopia, also known as farsightedness, is part of the normal aging process and occurs in patients during their early 40’s due to a change of the aging lens. It affects 100% of the population during the normal human life span. This change in the lens often results in a need for reading glasses especially for close-up tasks such as reading. Due to the decreased stretching involving the lens of the eye, the lens becomes stiff and is unable to change shape. Various forms of treatment may be performed in hopes of restoring the natural focusing ability to the lens and include bifocals, trifocals, monovision contact lenses, bifocal contact lenses and modified monovision. (1) Intraocular lens (IOLs) were developed for the visual correction of presbyopia and for astigmatism (imperfection in the curvature of your cornea) following cataract surgery.

IOL is a permanent, artificial ocular lens that is surgically implanted to replace or supplement the eye’s natural crystalline lens. (2) Replacement of the natural lens of the eye is required to restore vision in cases where the lens is surgically removed (e.g. cataract surgery). (3) Rigid polymethyl methacrylate (PMMA) IOLs were the most frequently used lens prior to the use of foldable IOLs which may be used to replace the lens after extraction in cataract surgery and to treat other conditions such as presbyopia. Foldable IOLs are now the most commonly used IOLs because they can be implanted through smaller incisions. Foldable IOLs are classified according to their optic material: silicone, hydrophilic acrylic, hydrophobic acrylic, and collagen/hydroxy ethyl methacrylate-copolymer based. The choice of IOL is dependent on physician recommendation and the visual needs of each patient.(4)

Monofocal IOLs:

Monofocal lenses are the most commonly implanted ocular lenses since the accommodative capability of the eye (which allows variable focusing) is usually lost after cataract surgery. The traditional monofocal IOL is designed with a fixed optical power primarily providing high-quality distance vision, but does not correct near vision simultaneously. The use of monofocal IOLs as replacement for the cataract lens will typically require the use of corrective contact lenses or eyeglasses after surgery for near vision tasks such as reading. Monofocal lenses do not correct pre-existing astigmatism, a result of irregular corneal shape that can distort vision at all distances. (5)

In 2009, the United States (U.S.) Food and Drug Administration (FDA) approved the monofocal IOL Tecnis® (American Medical Optics, Santa Ana, CA.). (6, 7) In 2017, Johnson and Johnson Vision acquired Abbott Medical Optics, formally known as American Medical Optics. (8) Traditional IOLs are spherical (i.e., the front surface is curved); aspheric lenses are slightly flatter and designed to provide better contrast sensitivity. The Tecnis lens is an aspheric (molded and precision polished) wavefront designed optic that reduces spherical aberration and improves functional vision in varying light conditions (e.g., rain, snow, fog, twilight and nighttime). (2, 9)

Multifocal IOLs:

Multifocal IOLs, also known as pseudo accommodative lenses, have more than one focal point and are designed to provide distance and near vision simultaneously. These lenses are considered an optional lens for patients in need of cataract surgery. (10, 11) Presbyopia-correcting (near vision correcting) IOLs, include, but are not limited to, accommodating and multifocal IOLs, these lenses are designed to restore a fuller range of near, intermediate and far distance vision as compared to monofocal IOLs. Multifocal IOLs have some limitations which may include halos, glare, and starbursts due to the light scatter that naturally occurs when transitioning between near and distance vision and reduced intermediate (mid-range) vision. (12, 13)

AcrySof® IQ ReSTOR® Posterior Chamber IOL is one of the multifocal IOLs is indicated for the visual correction of aphakia secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision without the need for additional contacts or glasses. (14, 15) This type of lens is intended to be placed in the capsular bag, is foldable and is available in a multi-piece (MA60D3) or single-piece design (SA60D3). (15)

Accommodating IOLs:

Visual accommodation is the ability of the eye to change focus and provide a clear image over a range of distances (near and far). Accommodating IOLs are designed to work with the muscles of the eye to reproduce the focusing ability of the lens. This is accomplished by changing the position of the lens rather than changing its shape which keeps an object in focus on the retina as the distance from the eye varies. (16) During accommodation, the ciliary body applies pressure to the vitreous as it contracts. The pressure, in combination with an increasing laxity of the zonules, (a series of fibers connecting the ciliary body and lens of the eye) that causes the lens to move forward, increasing its relative optical power, and allowing the eye to focus for close work. (17, 18)

Accommodating IOLs are designed to provide good distance, intermediate and near vision. (12) They allow patients to see by providing a continuous range of vision and may be considered an alternative to multifocal lenses. (18) Information from the manufacturer suggests this lens reduces the need for postoperative corrective lenses. (19) The accommodating IOL interacts with the ciliary muscles and zonules. (18) The device has hinges at both ends to facilitate the forward and backward movement allowing variable focus capability. (19)

Crystalens was the first FDA-approved accommodating posterior chamber IOL. (19) This lens is indicated for primary implantation in the capsular bag of the eye for visual correction in adult patients in whom a cataractous lens has been removed and is intended to provide near, intermediate and distance vision without the use of spectacles. (20) Unlike multifocal lenses, Crystalens directs all available light received by the eye to a single focal point, so that you can focus on objects at all distances. (19)

Toric Lens

A toric IOL is a “premium” IOL that has different optical power and focal length in two orientations perpendicular to each other; it is used to correct astigmatism. The same type of correction can also be done with eyeglasses or contact lenses. (2)

Ultraviolet (UV) Absorbing IOLs

UV radiation in sunlight is commonly divided into two components: UV-B short wavelength radiation (280 to 315 nanometers), and UV-A (315 to 400 nanometers) radiation. The natural crystalline lens in the eye absorbs most UV-B light (300–315 nm) and all UVA light thereby protecting the retina from a significant source of photochemical damage. This protection is lost when the lens is removed by cataract surgery, but can be restored by the implantation of an IOL that has UV-absorbing chromophores included in the substrate. UV absorbing lenses consist of monofocal or multifocal IOLs. Individuals who have had cataract surgery are at increased risk of retinal injury from sunlight unless a UV absorbing IOL was implanted at the time of surgery. Not all UV-absorbing IOLs have the same ability and are not all equally effective. However, there are usually positive outcomes for patients with a UV-absorbing IOL. This type of lens may restore normal spectral sensitivity. (21-23)

Spectrophotometric data show that the various, commercially available, UV-absorbing IOLs are not equally effective in absorbing UV radiation; thus, a standard, quantitative metric for comparing their performance is proposed. Cytotoxicity and biocompatibility studies have failed to demonstrate that UV-absorbing IOLs are unsafe, even when damaged by Nd: YAG lasers used for photo discussion posterior capsulotomy. There are positive consequences for the pseudophakic patient with a UV-absorbing IOL, in that it may restore normal spectral sensitivity, reduce erythropsia and incident of cystoid macular edema, and will help to stabilize the blood-vitreous barrier. (24)

Implantable Miniature Telescope (IMT)

The IMT device is a small telescope that when surgically implanted replaces the natural lens. The IMT is designed to magnify and project images onto a healthy portion of the retina to allow patients to recognize and identify objects that they could not otherwise see. The device enlarges the retinal image in the patient’s central visual field between 2- and 3-fold, reducing the impact of the central scotoma (spot in the visual field in which vision is absent or deficient). The IMT is available in two models: one that provides 2.2X magnification and another 2.7X magnification (the 3.0X model). Since it reduces peripheral vision, it is intended to be implanted in only one eye; the non-implanted eye provides peripheral vision for spatial orientation and mobility. (25)

Implantation can lead to extensive loss of corneal endothelial cells, resulting in the need for device removal and corneal transplant. To ensure that the risks of IMT implantation are consistently communicated to patients, the FDA and the manufacturer created detailed labeling that includes an Acceptance of Risk and Informed Decision Agreement, which patients must complete prior to IMT implantation. Patients must also have a successful trial with an external telescope prior to device implantation. (25)

Regulatory Status

Intraocular Lenses

Table 1 is a partial listing of FDA approved IOLs and is not an all-inclusive list. Refer to the U.S. FDA for specific IOLs not listed in this policy. The U.S. FDA IOL implants are considered prosthetic devices and regulated by the FDA as Class III devices and are approved through the premarket approval (PMA) process.

Table 1.

FDA Approved IOLs

Monofocal

Multifocal

Accommodating

UV Absorbing

Advanced Medical Optics [AMO], Santa Anna, CA. Includes:

Tecnis®

Z9000 (26)

Z9001 (26)

Z9002 (27)

ZA9003 (28)

Advanced Medical Optics [AMO], Santa Ana, CA.

Includes:

Array® Model SA40e (29)

Array® Model AA50 (29)

ReZoom™ Model NXG1 (29)

Tecnis ZM900 (30)

ZMA00 (30)

Eyeonics Inc., Aliso Viejo, CA.

Includes:

Crystalens (31)

Alcon, Inc., Fort Worth, TX.

Includes:

AcrySof Natural blue-light filtering IOL. (32)

Bausch & Lomb, Rochester, N.Y.

Includes:

SofPort AO IOL (33)

Sofport LI61AO (34)

Alcon, Inc., Fort Worth, TX. Includes:

Acrysof ReSTOR SA60D3 (35)

Acrysof Natural ReSTOR SN60D3(35)

AcrySof ReSTOR MA60D3(35)

AcrySof ReSTOR MN60D3(35)

AcrySof ReSTOR Aspheric IOL model SN6AD1 (36)

AcrySof ReSTOR IQ IOL model SN6AD3. (37)

Staar Toric IOL (Star Surgical, Monrovia, CA.).

Includes:

AcrySof Aspheric Toric IOL SN6AT3 (38)

SN6AT5 (38)

AcrySof Toric® Model SA60T (39)

Bausch & Lomb, Rochester, N.Y. Includes:

SofPort AO IOL with Violet Shield Technology. (34)

Hoya Surgical Optics, Chino Hills, CA.

Includes:

Isert PY-60AD (40)

Alcon Surgical, Fort Worth, TX. Includes:

Tecnis AMO Aspheric IOL ZCB00 (41)

Acrysof IQ SN60WS (42)

N/A

Alcon, Inc., Fort Worth, TX.

Includes:

AcrySof Toric IOL (43)

ACRYSOF Toric Models SA60T3 (44)

AcrySof Toric®

SA60T4 (44)

SA60T5 (44)

AcrySof Toric Model SA60TT (44)

Rayner Surgical Inc., Los Angeles, CA. Includes:

C-flex IOL model 570C. (45)

Table Key: CA: California; IOL: Intraocular lens; N/A: Non-applicable; TX: Texas

Implantable Miniature Telescope (IMT)

In July 2010, the FDA approved the IMT prosthesis (Vision-Care Ophthalmic Technologies, Saratoga, CA.) to improve vision in patients 75 years and older with end-stage age-related macular degeneration (AMD). (46) In 2015, the FDA label was expanded to include patients between the ages of 65 and 74, in addition to those 75 and older. (47)

Proprietary names include Implantable Miniature Telescope™ (Models Wide Angle 2.2X and Wide Angle 2.7X). (48) Product code NCJ. (47)

Rationale:

This policy was originally developed in 1990 and has been updated with searches of scientific literature through October 31, 2017. Following is a summary of the key literature to date.

Intraocular Lenses (IOL)

In 2005, Marshall et al. (49) studied the safety and effectiveness of the new AcrySof Natural (Alcon Laboratories, Inc.) blue-light filtering IOL, which was designed to achieve a light-transmission spectrum similar to the natural human crystalline lens. This was a prospective randomized patient-masked multicenter study, in which 150 patients received the AcrySof Natural IOL and 147 patients received the AcrySof single-piece IOL as a control. Patients with bilateral age-related cataracts who were willing and able to wait at least 30 days between cataract procedures and had verified normal preoperative color vision were eligible for the study. Standardized surgery included a 4.0 to 5.0 mm capsulorhexis and phacoemulsification. All lenses were inserted in the capsular bag, with verification of in-the-bag placement of both haptics. In all bilateral implantation cases, the same model IOL was used in each eye. Postoperatively, contrast sensitivity and color perception were measured up to 180 days and up to 1 year (for visual acuity) after implantation. No statistically significant differences were discovered between the 2 patient groups in visual acuity (VA), contrast sensitivity evaluated under mesopic and photopic conditions, or the number of patients who passed the Farnsworth D-15 color perception test. There were no lens-related adverse events in either group. The study concluded that the blue-light filtering AcrySof Natural IOL is equivalent to the conventional AcrySof lens in terms of postoperative visual performance. Additional long-term clinical studies are needed to determine whether the IOL actually provides the theoretical benefits to retinal health.

In 2005, Heatley et al. (50) compared the near visual clinical performance of an accommodative IOL with a standard monofocal IOL in a prospective, randomized study. Thirty patients (60 eyes) with bilateral cataracts (but otherwise normal eyes) were recruited from a single university hospital. Patients were randomized to receive either the 1CU accommodative IOL in their first eye or the Acrysof MA30 monofocal IOL. The alternative lens was then implanted in the second eye 4 to 6 weeks later. At all follow-up visits, a full assessment was made of distance, near and reading visual performance, and accommodative amplitude. Data was evaluated in 30 patients at 6 months and 20 patients at 1 year. At 6 months, no difference was noted in distance-corrected VA between the two IOLs. Of the 1CU eyes, 9 patients (30%) could read J6 or better at a reading speed of 80 words/minute or better. In these 9 patients, the mean difference in the amplitude of accommodation between the 2 eyes was 0.71 diopters. The accommodative IOL appears to produce improved near vision in some eyes, but it does not work in all eyes, and in eyes where there is apparent accommodation, there is a discrepancy between subjective reading performance and the modest measured increase of accommodative amplitude.

In 2010, Takakura et al. (51) conducted a meta-analysis to compare accommodating IOLs and monofocal IOLs in restoring accommodation in cataract surgery.Because of measurement-scale variations, outcomes were pooled for distance-corrected near visual acuity (DCNVA) as standardized mean differences with 95 % confidence intervals [CIs] and anterior displacement of the lens as weighted mean differences (95 % CI).The meta-analysis comprised 12 randomized controlled studies of 727 eyes.The authors reported that, based on 10 studies that compared DCNVA, accommodating IOLs were favored but failed the test of heterogeneity (I(2)=94 %).However, pooling onlythe 6 homogeneous trials (I(2)=43 %) showed no difference (standardized mean difference, -0.16; 95 % CI: -0.56 to 0.25).The authors stated that heterogeneity could not be explained by any characteristic of the study population or methodology.Based on 4 studies that evaluated pilocarpine-induced IOL shift, there was a significant anterior compared with the control (weighted mean difference, 95 % CI: -0.36 - 0.47 to -0.24), although the studies were heterogeneous (I(2)=58 %).Three of 5 studies mentioning posterior capsule opacification reported increased rates in the accommodating IOL group postoperatively.The meta-analysis concluded that there was no clear evidence of near acuity improvement with accommodating IOLs compared to monofocal IOLs. Further randomized controlled studies with standardized methods evaluating adverse effects (e.g., posterior capsular opacification) are needed to clarify the trade-offs.

In 2016 de Silva and colleagues (52) stated that good unaided distance VA is now a realistic expectation following cataract surgery and IOL implantation. However, near vision still requires additional refractive power, typically in the form of reading glasses. Multi-focal IOLs claim to allow good vision at a range of distances although, it is unclear whether this benefit outweighs the optical compromises inherent in multi-focal IOLs. Investigators evaluated the visual effects of multi-focal IOLs in comparison with the current standard treatment of mono-focal lens implantation. They searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register), Ovid Medline, Ovid Medline In-Process and other non-indexed citations, Ovid Medline Daily, Ovid Old Medline (January 1946 to June 2016), Embase (January 1980 to June 2016), the ISRCTN registry, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform (ICTRP). Researchers did not use any date or language restrictions in the electronic searches. In June 2016, all RCTs comparing a multi-focal IOL of any type with a mono-focal IOL as a control were included. Both unilateral and bilateral implantation trials were also incorporated. They also considered trials comparing multi-focal IOLs with "monovision" where 1 eye was corrected for distance vision and 1 eye was corrected for near vision. Researchers used standard methodological procedures expected by Cochrane. The “certainty” of the evidence was graded. The authors concluded that multifocal IOLs are effective at improving near vision relative to monofocal IOLs although there is uncertainty as to the size of the effect. Whether that improvement outweighs the adverse effects of multifocal IOLs, such as glare and haloes, will vary between people. Also, the motivation to achieve spectacle independence is likely to be the deciding factor.

National Institute for Health and Clinical Excellence (NICE)

In 2007, NICE published guidance on the current evidence regarding the implantation of accommodating IOLs for cataracts. (53) The guidance concluded: “Evidence suggests that there are no major safety concerns associated with the implantation of accommodating lenses for cataract. There is evidence of short-term efficacy in correcting visual acuity but there is inadequate evidence that the procedure achieves accommodation. Therefore, the procedure should not be used without special arrangements for consent and for audit or research.”

In 2008, NICE published guidance on Implantation of multifocal (non-accommodative) IOLs during cataract surgery. (54) NICE concluded: "The evidence on the implantation of multifocal (non-accommodative) intraocular lenses (IOLs) during cataract surgery raises no major safety concerns. Current evidence on the procedure’s efficacy shows that it can provide good near and distance vision without the need for spectacles, but this is at the risk of a variety of potential visual disturbances."

American Academy of Ophthalmology (AAO)

In 2016, the AAO published a preferred practice pattern for cataracts in the adult eye. (55) The AAO has the following recommendations:

The standard of care in cataract surgery in the U.S. is a small-incision phacoemulsification with foldable IOL implantation. It is a standard of care that has withstood the test of time.

Cumulative lifetime exposure to ultraviolet-B radiation has been associated with lens opacities. Therefore, brimmed hats and ultraviolet-B blocking sunglasses are reasonable precautions to recommend to patients. (II, good quality, strong recommendation)

Summary of Evidence: IOLs

The use of toric, multifocal, accommodating, as an alternative to monofocal IOLs is considered to be predominately for comfort and convenience, that is, to eliminate the need for spectacles and/or contact lenses. The available peer-reviewed literature has failed to establish superiority of these IOLs, in terms of safety and long-term benefit over monofocal IOLs and conventional eyewear.

Implantable Miniature Telescope (IMT)

In July 2010, the FDA approved the IMT through the premarket approval (PMA) application process for the models Wide Angle 2.2X and Wide Angle 2.7X. The approved indication was “for monocular implantation to improve vision in patients greater than or equal to 75 years of age with stable severe to profound vision impairment (best corrected distance visual acuity 20/160 to 20/800) caused by bilateral central scotomas associated with end-stage age-related macular egeneration.” The FDA also listed numerous additional conditions and contraindications. In October 2014, the FDA approved an expanded indication to allow implantation in patients aged 65 years or older. (46, 47) The current coverage is based on the FDA labeled indications. Following is the key literature to date.

In 2006, Hudson et al. (56) evaluated the safety and efficacy of IMT in patients with bilateral, end-stage age-related macular degeneration (AMD). This prospective, open-label, multicenter clinical trial followed 217 patients (mean age, 76 years) with AMD and a moderate to profound bilateral central visual acuity loss (20/80-20/800) that resulted from bilateral untreatable atrophy, disciform scars, or both. An IMT was implanted monocularly in the capsular bag after lens extraction. Fellow eyes were not implanted to provide peripheral vision and to serve as a control. Study patients participated in 6 visual rehabilitation visits after surgery. Best-corrected distance visual acuity (BCDVA) and best-corrected near visual acuity (BCNVA), quality-of-life scores from the National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) and the Activities of Daily Life scale, ECD, and incidence of complications and adverse events were evaluated. At 1 year, 67% of implanted eyes achieved a 3-line or more improvement in BCDVA versus 13% of fellow eye controls (P<0.0001). Fifty-three percent of implanted eyes achieved a 3-line or more improvement in both BCDVA and BCNVA versus 10% of fellow eyes (P<0.0001). Mean BCDVA and BCNVA improved 3.5 lines and 3.2 lines, respectively, in implanted eyes versus 0.8 lines and 1.8 lines, respectively, in fellow eyes (P<0.0001). Change in visual acuity was not related to lesion type. Mean NEI VFQ-25 scores improved by more than 7 points from baseline (P<0.01) on 7 of 8 relevant subscales. Eleven eyes did not receive the device because of an aborted procedure. ECD was reduced by 20% at 3 months and 25% at 1 year. The decrease in ECD was correlated with postsurgical edema (P<0.0001), and there was no evidence that endothelial cell loss is accelerated by ongoing endothelial trauma after implantation. This 1-year study concluded that IMT can improve visual acuity and quality of life in patients with moderate to profound visual impairment caused by bilateral, end-stage AMD.

In 2008 Hudson et al. (57) also evaluated the long-term safety and best-corrected visual acuity (BCVA) results with the use of IMT in patients with end-stage AMD. This was a prospective, open-label clinical trial study with fellow-eye controls. Patients with end-stage AMD (bilateral geographic atrophy or disciform scars; BCVA, 20/80 to 20/800) received the telescope prosthesis at 28 centers. Methods were similar to those described in the one-year results, with follow-up visits continuing at 18 and 24 months. Main outcome measures included BCVA change from baseline, ECD and morphometry, and incidence of complications. At 2 years, data from 174 (92.6%) of 188 available patients were reviewed. Overall, 103 (59.5%) of 173 IMT implanted eyes gained 3 lines or more (doubling of visual angle) of BCVA compared with 18 (10.3%) of 174 fellow control eyes (P < .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. Overall the long-term results of the IMT showed substantial BCVA improvement at 1 year is also maintained at 2 years.

In 2015 Boyer and colleagues (58) evaluated the long-term results of an IMT in patients with bilateral, end-stage, AMD. A prospective, open-label, multicenter clinical trial with fellow eye controls enrolled 217 patients (mean age 76 years) with AMD and moderate-to-profound bilateral central visual acuity loss (20/80-20/800) resulting from untreatable geographic atrophy, disciform scars, or both. A subgroup analysis was performed with stratification for age (patient age 65 to <75 years [group 1; n=70] and patient age ≥75 years [group 2; n=127]), with a comparative evaluation of change in best-corrected distance visual acuity (BCDVA), quality of life, ocular complications from surgery, adverse events, and ECD. Follow-up in an extension study was 60 months. Data were available for 22, 38, and 31 patients in group 1 and 42, 46, and 32 patients in group 2 at 36, 48, and 60 months, respectively. Mean BCDVA improvement from baseline to 60 months was 2.41±2.69 lines in all patients (n=76), with 2.64±2.55 lines in group 1 and 2.09±2.88 lines in group 2. Quality of life scores were significantly higher in group 1. The most common significant surgery-related ocular complications in group 1 were iritis >30 days after surgery (7/70; 10%) and persistent corneal edema (3/70; 4.3%); and in group 2 were a decrease in BCDVA in the implanted eye or IMT removal (10/127 each; 7.9%), corneal edema >30 days after surgery (9/127; 7.1%), and persistent corneal edema (6/127; 4.7%). Significant adverse events included four corneal transplants, comprising two (2.9%) in group 1 and two (1.6%) in group 2. At 60 months, one patient in group 1 (3.2%) and three patients in group 2 (9.4%) had lost ≥2 lines of vision. The IMT was removed in one (1.4%) and ten (7.9%) patients in group 1 and group 2, respectively. Mean ECD loss was 20% at 3 months. Chronic loss was 3% per year. ECD loss was less in group 1 than in group 2 (35% versus 40%, respectively) at 60 months. Long-term results showed substantial retention of improvement in BDCVA. Chronic ECD loss was consistent with that reported for conventional IOLs. The IMT performed as well in group 1 (the younger group) as it did in group 2 through month 60. Younger patients retained more vision than their older counterparts and had fewer adverse events. Although not a specified outcome for this study, patients younger than 65 years also fared better than those in group 2 and retained more vision with fewer adverse events through month 60.

ECRI

In March 2015, ECRI published a product brief, the focus of which was IMT implantation. There was no information identified that would change the coverage position of this policy. (48)

National Institute for Health and Clinical Excellence (NICE)

In 2016, NICE (59) published evidence-based recommendations on miniature lens system implantation for advanced AMD. This involves implanting an artificial lens system into one eye only. Evidence on the efficacy of miniature lens system implantation for advanced AMD shows that the procedure can improve both vision and quality of life in the short term. Data on short-term safety are available for limited numbers of patients. There is currently insufficient long-term evidence on both efficacy and safety. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research.

American Academy of Ophthalmology (AAO)

The 2015 AAO Preferred Practice Pattern for AMD (60) recognizes IMT as an FDA-approved device that may be effective for screened, phakic, motivated patients with end-stage AMD.

Clinical Trials

One ongoing clinical trial related to the use of IMT for AMD was identified (61):

Post-Approval Study of VisionCare's Implantable Miniature Telescope (by Dr. Isaac Lipshitz) in Patients with Bilateral Severe to Profound Central Vision Impairment Associated with End-stage Age-related Macular Degeneration (NCT01757132), is a prospective, multicenter, open-label, single-group assignment safety study to "assess the safety of the intraocular telescope as measured by the cumulative incidence of patients who within five years after implantation experience persistent vision-impairing corneal edema." Study investigators at 8 U.S. sites plan to enroll up to 770 patients, who will receive up to 5-years' follow-up. The study began August 2010; the updated completion date is December 2023.

Summary of Evidence: IMT

Current evidence of published peer reviewed literature is adequate to permit scientific conclusions regarding the short-term safety and efficacy of implantable miniature telescope (IMT) for the diagnosis of age-related macular degeneration (AMD). Additional long term RCTs with sufficiently large sample sizes are needed for use of IMT outside of the U.S. FDA labelled indications.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

0308T

HCPCS Codes

C1780, C1840, L8609, L8610, Q1004, Q1005, S0596, V2630, V2631, V2632, V2787, V2788.

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-PX manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-PX manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. Boyd K. What is presbyopia? American Academy of Ophthalmology. 2017. Available at <https://www.aao.org> (accessed 2017 October 31).

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3. Thompson V. Cataract surgery. Available at <http://www.allaboutvision.com> (accessed 2017 October 19).

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Policy History:

Date Reason
1/1/2018 Document updated with literature review. Coverage unchanged. Title changed from Intraocular Lens (IOL).
11/15/2016 Reviewed. No changes.
2/15/2016 Document updated with literature review. The following criterion (age requirement) in the Coverage section was updated: The Implantable Miniature Telescope (IMT) may be considered medically necessary for monocular implantation when the following criteria are met: Patient is 65 years or older with stable severe to profound vision impairment caused by blind spots (bilateral central scotoma) associated with untreatable end-stage AMD (age-related macular degeneration).
9/15/2014 Document updated with literature review. Coverage unchanged.
11/15/2012 The following was added: The Implantable Miniature Telescope (IMT) may be considered medically necessary for monocular implantation when the stated criteria are met. The following was changed: Aspherical monofocal intraocular lenses (IOLs) may be considered medically necessary when used to replace the natural crystalline lens of the eye when the natural lens becomes cataractous; Toric intraocular lenses are considered not medically necessary.
12/15/2011 Document updated with literature review. Coverage unchanged, rationale revised.
10/15/2009 CPT/HCPCS code(s) updated
10/15/2008 CPT/HCPCS code(s) updated
8/15/2008 Revised/updated entire document
6/1/2008 Coverage Revised
1/1/2008 Codes Revised/Added/Deleted
10/15/2007 Revised/Updated Entire Document
7/15/2005 New medical document

Archived Document(s):

Title:Effective Date:End Date:
Intraocular Lens (IOLs) and Implantable Miniature Telescope (IMT)01-01-201801-14-2019
Intraocular Lens (IOL)11-15-201612-31-2017
Intraocular Lens (IOL)02-15-201611-14-2016
Intraocular Lens (IOL)09-15-201402-14-2016
Intraocular Lens (IOL)11-15-201209-14-2014
Intraocular Lens (IOL)12-15-201111-14-2012
Intraocular Lens (IOL)10-15-200912-14-2011
Intraocular Lens (IOL)10-15-200810-14-2009
Intraocular Lens (IOL)08-15-200810-14-2008
Intraocular Lens06-01-200808-14-2008
Intraocular Lens10-15-200705-31-2008
Intraocular Lens09-01-200610-14-2007
Intraocular Lens07-15-200508-31-2006
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