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 intraocular lenses are considered not medically necessary.
The Implantable Miniature Telescope (IMT) may be considered medically necessary for monocular implantation when the following criteria are met:
1. Patient is 75 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: Patient should undergo postoperative training with a low vision specialist after IMT implantation.
NOTE: 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 FDA and the manufacturer created detailed labeling that includes an Acceptance of Risk and Informed Decision Agreement.)
The use of toric, multifocal, accommodating and ultraviolet absorbing intraocular lenses as alternatives to monofocal IOLs is considered to be for convenience, (i.e., to eliminate the need for eye-glasses or contact lenses).
Available peer reviewed literature through August 2011 for other types of IOLs (i.e., toric, multifocal, accommodating, ultraviolet absorbing etc.) as an alternative to monofocal IOLs for replacement of cataract lenses has failed to establish an increase in benefits in terms of safety and long-term benefit over the monofocal IOL and conventional eyewear.
FDA approval of the Implantable Miniature Telescope (IMT) was based on 1- and 2-year safety and efficacy outcomes in 206 implanted eyes; 1- and 2-year safety and efficacy outcomes from the 28-center pivotal trial have been reported. (49, 50). Patients were at least 55 years of age and had bilateral, stable, central visual acuity loss caused by untreatable end-stage AMD (age-related macular degeneration), with evidence of cataract in the study eye. To be eligible for enrollment, patients had to achieve at least a 5-letter improvement on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart with an external telescope, and patients were informed that they would experience an overall reduction in field of view because of field restriction in the implanted eye. The other (fellow) eye, which also had to have central visual acuity loss caused by untreatable end-stage AMD, served as a control. Patient exclusion criteria included active choroidal neovascularization (CNV), treatment of CNV in the preceding 6 months, history of intraocular or corneal surgery in the study eye, endothelial cell density < 1600 cells/mm2, and narrow angle (less than Schaffer grade 2). A total of 217 patients (mean age 76 years) with AMD and moderate to profound bilateral central visual acuity loss (mean 20/316; range, 20/80 -20/800) were enrolled in the study. Eleven eyes (5%) did not receive the device because of an aborted procedure, resulting in 206 implanted eyes. Study patients participated in 6 visual rehabilitation visits after surgery. Patients were examined after surgery on days 1 and 7 and at 1, 3, 6, 9, 12, 18 and 24 months. One hundred and ninety-two patients (93%) were available for 12-month follow-up. Seven patients were discontinued due to death, 3 were discontinued because of explant, and 4 patients were lost to follow-up. At 12 months, mean best-corrected distance visual acuity (BCDVA) had improved by 3.5 lines versus 0.8 lines in the untreated (fellow) eye. Best-corrected near visual acuity (BCNVA) had improved by 3.2 lines versus 1.8 lines in the other eye. At 1 year, 67% of 192 implanted eyes achieved a 3-line or more improvement in BCDVA versus 13% of the patients’ other eyes. Ninety percent of implanted patients achieved at least a 2-line improvement in BCDVA or BCNVA (the primary efficacy outcome). At 1 year, loss of > 2 lines was observed in 2.1% of implanted eyes and 8.9% of fellow eyes. Eyes implanted with the 3X device had greater improvement in BCDVA than those implanted with the 2.2X device. Mean quality of life scores from the National Eye Institute 25-item Visual Function Questionnaire improved by 6.1 points from baseline with an improvement of > 7 points from baseline on 7 of 8 relevant subscales (5-point improvement considered clinically significant). Ocular complications and adverse events included an increase in intraocular pressure within 7 days (28%) and inflammatory deposits on the device (21%). Endothelial cell density was reduced by 20% at 3 months and 25% at 1 year.
In the 1-year study, 10 eyes had unresolved corneal edema, with 5 resulting in device removal and corneal transplants. At 2-year follow-up, data from 174 patients (84.5% of 206) were analyzed, with an additional 8 patients (3.9%) who had the device removed. (50) This was out of a reported total of 188 patients who were available for the 2-year assessment; 10 patients (4.9%) had died and 14 (6.8%) were lost to follow-up. Mean best-corrected visual acuity (BCVA) improved 3.6 lines with the 3X model and 2.8 lines with the 2.2X model. Out of 173 telescope implanted eyes, 103 (59.5%) gained > 3 lines of BCVA compared with 18 (10.3%) of 174 fellow control eyes. Loss of > 3 lines occurred in 1 of 173 (0.6%) telescope-implanted eyes compared with 13 of 174 (7.5%) fellow eyes. For 6 of 8 study eyes that had the telescope removed and received an intraocular lens, the mean BCVA line change was -0.2 lines (BCVA not reported for the other 2 eyes). The most common complications were inflammatory deposits (25%) and pigment deposits (11%) on the device, followed by guttae (8%), posterior synechiae (7%), iris transillumination defects (5%), and iritis (6%). The mean endothelial cell density stabilized after the first year of the study with a 2.4% mean cell loss between 1 and 2 years. These results suggest that endothelial cell loss is related to surgical trauma, rather than the device itself. The calculated 5-year risk for unresolved corneal edema, corneal decompensation, and corneal transplant are 9.2 percent, 6.8 percent and 4.1 percent, respectively.
The FDA-approved indications (51) are for use of the IMT in a subset of patients who were included in the pivotal trials, specifically:
- Patients who are 75 years and older with stable severe to profound vision impairment caused by blind spots (bilateral central scotoma) associated with end-stage AMD. Patients should also have evidence of a visually significant cataract.
- Patients agree to undergo training with an external telescope prior to implantation to determine whether adequate improvement in vision can be obtained and to verify if the patient has adequate peripheral vision in the eye that would not be implanted.
- Patients must also agree to undergo postoperative training with a low vision specialist.
- 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 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.
As a condition of approval, the manufacturer was required to conduct two additional studies. In one study, VisionCare must continue follow-up on approximately 70 subjects from its long-term follow-up cohort for an additional two years. Another study of 770 newly enrolled subjects, 75 years of age or older, will include an evaluation of the endothelial cell density and related adverse events for five years after implantation.
In 2011, Brown and colleagues presented results from a phase III clinical trial evaluating 3X model IMT implantation procedure in 76 patients with end-stage AMD and severe vision loss whose disease is refractory to medications. Following the 2-year trial, authors reported, “vision improved from 20/326 to 20/141 (mean values) in 76 patients who received the 3X model IMT. Most patients could once again see people's faces rather than just blurry outlines, and could get around the market or their backyard on their own. Overall, these IMT patients' lives improved substantially and at a reasonable cost. Quality of life was measured using a system called human value gain, with standards based on the actual experiences of people with vision loss.” (52)
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