US FDA clinical trial of the Tetraflex potentially accommodating IOL: comparison to concurrent age-matched monofocal controls.

PURPOSE: To assess the efficacy of the Tetraflex (Lenstec Inc) intraocular lens (IOL) to provide enhanced near reading ability and spectacle independence relative to a monofocal control IOL in bilaterally implanted eyes tested binocularly. METHODS: A prospective, age-matched, non-randomized US Food and Drug Administration clinical trial of 255 Tetraflex and 101 monofocal IOL control patients was performed. To date, 239 Tetraflex and 96 control patients were examined at 12 months postoperatively. RESULTS: At 12 months postoperative, the Tetraflex patients read better than the controls at print sizes of 20/80 (P=.04), 20/63 (P=.01), 20/50 (P<.001), 20/40 (P=.001), 20/32 (P<.001), and 20/25 (P=.001). The proportion of patients reading at a speed of ≥80 words per minute was significantly higher with the Tetraflex IOL (P=.003). Ninety-six percent of Tetraflex patients reported never wearing glasses for distance compared with 80% of control patients (P<.001). Seventy-five percent of the Tetraflex patients reported near spectacle wear either never or only occasionally for small print and/or dim light (21% never) compared with 46% of control patients (P<.001) (9% never). Near add power requirement for corrected near visual acuity was less in the Tetraflex group (P<.001); 28% of Tetraflex patients required ≤1.25 diopters of near add, compared to only 7% of control patients. Spectacle independence, as measured by the proportion of patients with uncorrected distance visual acuity of 20/25 or better and various degrees of uncorrected near visual acuity, was also significantly better (P<.001) as was distance-corrected near visual acuity (P<.001). CONCLUSIONS: The results support the efficacy of the Tetraflex IOL to provide enhanced near reading ability and spectacle independence relative to a monofocal IOL control.

Functional reading acuity and performance: Comparison of 2 accommodating intraocular lenses.

PURPOSE: To compare functional reading acuity and speed with 2 models of accommodating intraocular lenses (IOLs). SETTING: Four of 12 investigative sites in a U.S. Food and Drug Administration (FDA) clinical study. METHODS: In this observational study, which was part of an ongoing FDA clinical trial, the MNRead functional reading test was used to compare the reading performance of patients with bilateral Tetraflex IOLs (Group 1) and a consecutive series of patients with bilateral Crystalens IOLs (Group 2) presenting at approximately 1 year postoperatively at 4 ophthalmic practices. The 2 groups were well matched for age, sex, mean postoperative time, and mean level of postoperative corrected distance visual acuity. All examinations were scored at a central reading center. RESULTS: Group 1 comprised 96 patients and Group 2, 55 patients. Patients in Group 1 read better than those in Group 2 at print sizes of 20/63 (P = .004), 20/50 (P = .002), 20/40 (P = .001), 20/32 (P = .003), and 20/25 (P = .001). A statistically significantly higher proportion of patients in Group 1 than in Group 2 read 80 words per minute or more throughout the range of print sizes (P = .002). CONCLUSION: Near reading ability was better with the Tetraflex accommodating IOL than with the Crystalens accommodating IOL at all print sizes between 20/25 and 20/63.

Comparison of the toric implantable collamer lens and custom ablation LASIK for myopic astigmatism.

PURPOSE: To compare the results of wavefront-guided custom LASIK and the Toric Implantable Collamer Lens (TICL) in the correction of myopic astigmatism. METHODS: This observational, non-randomized study compared clinical efficacy results from the TICL's US Food and Drug Administration Clinical Trial and published Summaries of Safety and Effectiveness of two wavefront-guided lasers: STAR S4 CustomVue excimer laser system (VISX Inc) and LADARVision4000 CustomCornea excimer laser system (Alcon Laboratories Inc). Preoperative myopic refractive error was divided into two groups: -3.00 to -7.00 diopters (D) and -7.00 to -11.00 D. RESULTS: The percentage of eyes with uncorrected visual acuity (UCVA) of 20/20 and 20/40 and predictability of manifest refraction spherical equivalent within +/- 0.50 and +/- 1.00 D in the three groups was similar with only one statistically significant difference (TICL versus Alcon within +/- 1.00 D: 97% versus 82%; P = .008). The TICL had significantly better postoperative best spectacle-corrected visual acuity (BSCVA) compared to preoperative BSCVA than both the VISX CustomVue and Alcon CustomCornea (P < .001). The TICL postoperative UCVA outcomes compared to preoperative BSCVA were significantly better than Alcon CustomCornea outcomes (P < .001). Additionally, almost half (48%) of the TICL cases had improvement in postoperative UCVA compared to preoperative BSCVA, whereas only 23% of the Alcon CustomCornea eyes showed improvement. CONCLUSIONS: Although comparable in clinical efficacy outcomes, the TICL had a significantly better postoperative improvement in BSCVA and significantly better postoperative UCVA than preoperative BSCVA. The TICL can be considered as an alternative to LASIK through the full range of use.

Randomized prospective comparison of visian toric implantable collamer lens and conventional photorefractive keratectomy for moderate to high myopic astigmatism.

PURPOSE: To compare the Visian Toric Implantable Collamer Lens (TICL), a toric phakic intraocular lens (IOL), and photorefractive keratectomy (PRK) in the correction of moderate to high myopic astigmatism. METHODS: This prospective, randomized study consisted of 43 eyes implanted with the TICL (20 bilateral cases) and 45 eyes receiving PRK with mitomycin C (22 bilateral cases) with moderate to high myopia (-6.00 to -20.00 diopters [D] sphere) measured at the spectacle plane and 1.00 to 4.00 D of astigmatism. All patient treatment and follow-up occurred at the Naval Medical Center San Diego. Study follow-up was 1 day, 1 week, 1, 3, 6, and 12 months postoperative. RESULTS: Mean best spectacle-corrected visual acuity (BSCVA), change in BSCVA, proportion of cases with improvement of 1 or more lines of BSCVA, proportion of cases with BSCVA and uncorrected visual acuity (UCVA) 20/12.5 or better, proportion of cases with BSCVA and UCVA 20/16 or better (6 months, 88% vs 54%, P=.002), and predictability +/-1.00 D (6 months, 100% vs 67%, P<.001) were all significantly better in the TICL group than the PRK group at all time periods studied postoperatively. Similarly, contrast sensitivity, tested at both the 5% photopic level and the 25% mesopic level, was significantly better at all postoperative time points in the TICL group. Mean spherical equivalent refraction was closer to emmetropia (0.28+/-0.41 vs 0.76+/-0.86, P=.005), and predictability +/-0.50 D and stability of manifest refraction (+/-0.50 D and +/-1.00 D) were significantly better in the TICL group at all postoperative visits through 6 months. Mean astigmatism correction at 6 months was not significantly different between the two groups (0.52+/-0.33 vs 0.46+/-0.35, P=.450). CONCLUSIONS: The TICL performed better than PRK in all measures of safety (BSCVA), efficacy (UCVA), predictability, and stability in this comparison, supporting the TICL as a viable alternative to existing refractive surgical treatments.

Near visual acuity for everyday activities with accommodative and monofocal intraocular lenses.

PURPOSE: To determine the levels of functional near visual acuity required for everyday social reading activities and to compare the levels to those attained with accommodative and monofocal intraocular lenses (LOLs). METHODS: Font size equivalencies of an Early Treatment Diabetic Retinopathy Study near chart and a variety of commonly read print objects were determined and correlated to the findings of distance-corrected near vision measurements with 2 accommodative (Tetraflex, 1CU) and 1 monofocal (Acrysof MA30) IOLs. RESULTS: The smallest print objects studied were sweetener packets with type between 20/40 (Jaeger [J] 5) and 20/50 (J6). Type in classified ads, stock quotations, and pocket bibles was 20/50 (J6), type in a telephone directory was 20/63 (J8), and type in standard newspapers, journals, and magazines was 20/80 (J9). Tested monocularly, 88% of Tetraflex, 40% of ICU, and 7% of Acrysof MA30 eyes had distance-corrected near vision sufficient to read newspaper and telephone directory print, and 63% of Tetraflex, 30% of 1CU, and 0% of Acrysof MA30 eyes could read classified ads, stock quotations, and pocket bibles, respectively. Tested binocularly after bilateral implantation, 96% of Tetraflex patients could read telephone directory print and 89% could read ads, stock quotations, and pocket bibles. CONCLUSIONS: Functional near visual acuity is not equivalent to the bottom-line objective at 20/20 (J1) near visual acuity. No print size was found at or smaller than 20/40 (J5), indicating that a requirement of nearly perfect near visual acuity, while desirable, may not be necessary for patients' social reading needs for accommodative IOLs.

Visual performance results after Tetraflex accommodating intraocular lens implantation.

PURPOSE: To present the clinical results that demonstrate the efficacy of the Tetraflex accommodative intraocular lens (IOL) in providing both enhanced distance and near acuity. DESIGN: Single-center prospective data collection performed in Manchester, United Kingdom. PARTICIPANTS: A series of 95 eyes of 59 patients implanted with the Tetraflex lens was performed by a single surgeon. Thirty-six of these cases were implanted bilaterally. INTERVENTION: Implantation of the Tetraflex accommodative IOL. MAIN OUTCOME MEASURES: Prospective data collection included both uncorrected distance visual acuity (UCDVA) and uncorrected near visual acuity (UCNVA) testing, manifest refraction, best-corrected distance visual acuity (BCDVA), distance corrected near visual acuity (DCNVA), and the amplitude of accommodation. Intraoperative and postoperative complications also were reported. RESULTS: At 6 months after surgery, 63% of all cases achieved a DCNVA of 20/40 or better. Virtually all of the patients had at least 1 diopter (D) of accommodative amplitude (98% at 1 month; 100% at 3 and 6 months); 75.7% had at least 2 D at 6 months after surgery. At 6 months or later, 92.2% had 20/40 or better UCDVA. The proportion of cases achieving a UCNVA of 20/40 or better remained relatively constant at 45% to 47%. At 6 months and later, 98.7% had a BCDVA of 20/40 or better. In the bilaterally implanted series, at 1 month after surgery, all patients had at least 1 D of accommodative ability; 96% had at least 2 D at 6 months. One hundred percent achieved a BCDVA, 89.3% achieved a DCNVA, and 74.1% achieved a UCNVA of 20/40 or better at 6 months after surgery. CONCLUSIONS: The Tetraflex accommodating IOL provides enhanced near vision with good distance vision 6 months after surgery.