sMap3D Corneo-Scleral Topographer Repeatability in Scleral Lens Patients.

OBJECTIVES: To determine repeatability of measurements using the sMap3D Corneo-Scleral Topographer in patients presenting for scleral lens fitting. METHODS: As part of our standard clinical evaluation, 25 eyes of 23 patients who presented for scleral lens fitting were examined twice in the same day with the sMap3D in this retrospective study. Sagittal height (SAG), sMap3D principal toricity magnitude (as calculated by the instrument software), and steep axis location were measured at a 16-mm chord diameter. Up gaze, primary, and down gaze positions of each eye were imaged and "stitched" by the instrument software into a single corneoscleral topography map from which the measurements were derived. RESULTS: The mean difference in SAG between the 2 examinations was 14 µm with an SD of 55 µm. Sixty-eight percent of cases had a difference of ≤50 µm, and 95% of cases had a difference of ≤100 µm. The mean difference in sMap3D principal toricity magnitude between examinations was 0.15 diopter (D) with an SD of 0.38 D. Eighty-four percent of cases had a difference of ≤0.5 D, and all cases had a difference of <1 D. Mean toric axis difference between examinations was 2.5° with an SD of 18.4°. Sixty-four percent of cases had an axis difference of ≤10°, and 84% had an axis difference of ≤15°. CONCLUSIONS: The sMap3D measurements are repeatable with regard to scleral toricity and SAG values at a 16-mm diameter and thus would be suitable to use for scleral lens fitting.

Surface coverage with single vs. multiple gaze surface topography to fit scleral lenses.

OBJECTIVES: To determine surface coverage of measurements using the sMap3D® corneo-scleral topographer in patients presenting for scleral lens fitting. METHODS: Twenty-five eyes of 23 scleral lens patients were examined. Up-gaze, straight-gaze, and down-gaze positions of each eye were "stitched" into a single map. The percentage surface coverage between 10mm and 20mm diameter circles from corneal center was compared between the straight-gaze and stitched images. Scleral toricity magnitude was calculated at 100% coverage and at the same diameter after 50% of the data was removed. RESULTS: At a 10mm diameter from corneal center, the straight-gaze and stitched images both had 100% coverage. At the 14, 15, 16, 18 and 20mm diameters, the straight-gaze image only covered 68%, 53%, 39%, 18%, and 6% of the ocular surface diameters while the stitched image covered 98%, 96%, 93%, 75%, and 32% respectively. In the case showing the most scleral coverage at 16mm (straight-gaze), there was only 75% coverage (straight-gaze) compared to 100% (stitched image); the case with the least coverage had 7% (straight gaze) and 92% (stitched image). The 95% limits of agreement between the 50% and 100% coverage scleral toricity was between -1.4D (50% coverage value larger) and 1.2D (100% coverage larger), a 2.6D spread. The absolute difference between 50% to 100% coverage scleral toricity was ≥0.50D in 28% and ≥1.0D in 16% of cases. CONCLUSIONS: It appears that a single straight-gaze image would introduce significant measurement inaccuracy in fitting scleral lenses using the sMap3D while a 3-gaze stitched image would not.

Accuracy and precision of a new system for measuring toric intraocular lens axis rotation.

We determined the accuracy and precision of a new system for measuring postoperative toric intraocular lens (IOL) axis rotation. The system performs high-resolution retroillumination photography to identify toric IOL axis markings and then takes a photograph of the iris and conjunctival/scleral vessels. Built-in software measures the toric axis to within 0.2 degree. If performed twice on the same eye, the system will correct the 2 toric axis measurements for cyclorotation/head tilt using iris/vessel registration. Testing in 37 eyes showed that using iris/vessel registration correction reduced the mean absolute toric IOL axis rotation by a factor of 4.5. We conclude that this system seems to be both accurate and precise for measuring postoperative toric IOL axis rotation.

Prospective multicenter trial assessing effectiveness, refractive predictability and safety of a new aberration free, bi-aspheric intraocular lens.

PURPOSE: To determine the effectiveness and safety of the Softec HD IOL; and to present refractive outcomes for lenses manufactured at an IOL power tolerance of 0.11 D. METHODS: Three-hundred and ninety adult patients requiring removal of a cataractous lens with implantation of a monofocal IOL in at least one eye were eligible for study participation across eight US investigative sites. Patients were enrolled unilaterally. After routine surgery, subjects were examined for adverse events (AEs), best corrected visual acuity (BCVA) and manifest refraction correction at 12 months postoperatively. RESULTS: Three-hundred and sixty-six (95%) of patients completed the 12-month postoperative visit. The percent of patients achieving best corrected Snellen acuity 20/40 or better was 98.9%, and 81.1% of patients achieved best corrected Snellen acuity 20/25 or better. Of those patients (80%) implanted with a lens available in 0.25 D increments (manufactured at a tolerance of 0.11 D) 40.9%, 69.8% and 93.8% of patients were within ±0.25 D, ±0.50 D and ±1.0 D of predicted target refraction respectively. Overall incidence of cumulative and persistent IOL Grid AEs was 2.2% with no AE meeting or exceeding the FDA Grid of Historical Controls. CONCLUSIONS: The Softec HD IOL is a safe and effective lens. The high manufacturing tolerance of the lens appears to enhance refractive outcomes.

Night driving simulation in a randomized prospective comparison of Visian toric implantable collamer lens and conventional PRK for moderate to high myopic astigmatism.

PURPOSE: To compare changes in simulated night driving performance after Visian Toric Implantable Collamer Lens (TICL; STAAR Surgical) implantation and photorefractive keratectomy (PRK) for 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 conventional PRK (VISX Star S3 excimer laser) with mitomycin C (22 bilateral cases) for 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. As a substudy, 27 eyes of 14 TICL patients and 41 eyes of 21 PRK patients underwent a simulated night driving test. The detection and identification distances of road signs and hazards with the Night Driving Simulator (Vision Sciences Research Corp) were measured with and without a glare source before and 6 months after each procedure. RESULTS: No significant difference was noted in the pre- to postoperative Night Driving Simulator in detection distances with and without the glare source between the TICL and PRK groups. The differences in identification distances without glare were significantly better for business and traffic road signs and pedestrian hazards in the TICL group relative to the PRK group whereas with glare, only the pedestrian hazards were significantly better. A clinically relevant change of Night Driving Simulator performance (>0.5 seconds change in ability to identify tasks postoperatively) was significantly better in the TICL group (with and without glare) for all identification tasks. CONCLUSIONS: The TICL performed better than conventional PRK in the pre- to postoperative Night Driving Simulator testing with and without a glare source present.

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.

The Visian myopic implantable collamer lens does not significantly affect axial length measurement with the IOLMaster.

PURPOSE: To compare pre- to postoperative axial length measurements with the IOLMaster (Zeiss Humphrey Systems) to determine whether a correction factor for later intraocular lens (IOL) power calculation is necessary with an Implantable Collamer Lens (ICL; STAAR Surgical) in place. METHODS: The commercially approved Visian ICL was implanted in 60 eyes from 3 separate sites (20 eyes each). Pre- and postoperative axial length measurements were obtained using partial coherence interferometry. RESULTS: The pre- and postoperative axial lengths were highly correlated with an R2 value of 0.9963. For all ranges of axial lengths tested, the use of postoperative axial length instead of preoperative axial length resulted in a <0.1-mm error in axial length measurements. CONCLUSIONS: Based on the SRK formula, a 0.1-mm axial length difference would result in a 0.25-diopter (D) change in calculated IOL power; possibly a 0.20-D change in manifest refraction. These differences are so small as to make any correction to IOL power calculation formula based on the presence of an ICL unnecessary.

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.

Cyclosporine 0.05% ophthalmic preparation to aid recovery from loss of corneal sensitivity after LASIK.

PURPOSE: To determine whether cyclosporine (0.05%) can safely and effectively accelerate corneal nerve regeneration after LASIK, thereby facilitating faster recovery of corneal sensitivity. METHODS: This prospective, randomized, single-center clinical study comprised 44 eyes of 22 patients scheduled to undergo bilateral LASIK. One eye was randomly assigned to receive cyclosporine drops twice daily for 3 months in addition to standard postoperative LASIK medication. Corneal sensitivity was measured using the Cochet-Bonnet esthesiometer in four areas outside and five areas inside the LASIK flap preoperatively and at 1 day, 1 week, 1 month, and 3 months postoperatively. Safety parameters of best spectacle-corrected visual acuity and the incidence of adverse events were also collected. RESULTS: For all four points outside the LASIK flap, normal corneal sensitivity was maintained throughout the study. In addition, no significant difference was found between the cyclosporine-treated eyes and the control eyes at these points. All points within the LASIK flap except the point closest to the hinge demonstrated profound corneal hypoesthesia at 1 day, 1 week, and 1 month postoperatively with no differences noted between the control and cyclosporine-treated eyes. These same points had statistically significantly greater corneal sensitivity in the cyclosporine group relative to the control group (P< or =.011) at 3 months postoperatively. CONCLUSIONS: Cyclosporine was shown to significantly improve corneal sensitivity at 3 months after LASIK, which suggests that topical cyclosporine promotes enhanced corneal nerve regeneration.

Custom-designed toric phakic intraocular lenses to correct high corneal astigmatism.

PURPOSE: To analyze the results of a custom-designed posterior chamber toric phakic intraocular lens (PIOL). METHODS: A 40-year-old woman with high astigmatism and thin corneas underwent bilateral PIOL implantation with the toric Implantable Collamer Lens (ICL) custom-designed and manufactured by STAAR Surgical. The appropriate toric ICL power was calculated to be -8.00 +8.00 x 96 degrees for the right eye and -8.50 +7.50 x 86 degrees for the left eye. Optical zone was 5.5 mm and 6.875 mm at the corneal plane. RESULTS: At 3 and 6 months postoperatively, uncorrected visual acuity (UCVA) and best-spectacle corrected visual acuity (BSCVA) of both eyes had improved to 20/20 and 20/16, respectively. At 19 months, UCVA was 20/20 and 20/16 in the right and left eyes, respectively, and BSCVA had improved to 20/16 and 20/10, respectively. The subjective refraction was stable, with a change of -0.37 +/- 0.17 D from preoperative to 19 months postoperatively. Throughout the postoperative period, iridotomies remained patent and the corneas were clear. CONCLUSIONS: Bilateral implantation of the custom-designed toric ICL successfully corrected the patient's high astigmatism. Preoperative subjective refractive cylinder of -5.25 x 6 degrees in the right eye and -5 x 176 degrees in the left eye changed to -0.5 x 77 degrees and -0.5 x 115 degrees, respectively, after toric IOL implantation. There was almost no change in corneal astigmatism. This customized approach led to UCVA of 20/20 in the right eye and 20/16 in the left eye, and BSCVA of 20/16 in the right eye and 20/10 in the left eye. This is the first report of a toric PIOL being specifically manufactured to meet the refractive cylinder requirements of a specific patient.

Inhibition of experimental angiogenesis of cornea by various doses of doxycycline and combination of triamcinolone acetonide with low-molecular-weight heparin and doxycycline.

PURPOSE: To evaluate the effect of topically administered doxycycline in various doses; the combination of triamcinolone acetonide and low-molecular-weight heparin (LMWH); and the combination of triamcinolone acetonide and doxycycline on experimental corneal neovascularization in rats. METHODS: This project is the combination of 2 separate studies. First, the chemical cauterization of corneas in 36 eyes of 36 Long Evans male rats was performed by using silver nitrate/potassium nitrate sticks. Topical instillation of doxycycline at 0.05% (pH = 3.3), 0.1% (pH = 3.1), 1% (pH = 2.3), 2% (pH = 2.1), 2% (pH neutralized to 7.4), and normal saline continued for 7 days. Second, the chemical cauterization of the corneas in 24 eyes of 24 rats was achieved by application of silver nitrate/potassium nitrate sticks. Topical instillation of triamcinolone acetonide (10 microg/mL) and either LMWH (10 mg/mL) or doxycycline (10 mg/mL) was compared with normal saline treatment of 7 days. For both studies, the percent area of the cornea covered by neovascularization and scar in each group was calculated separately by using computer software on digital photographs. All corneas were evaluated histopathologically in study and control groups. RESULTS: The mean percent area of corneal neovascularization determined in the eyes given doxycycline 0.05%, 0.1%, 1%, 2%, and 2% (pH neutralized) study groups and control groups was 69.8% +/- 18.0%, 64.5% +/- 14.0%, 56.4% +/- 20.8%, 54.8% +/- 6.0%, 36.2% +/- 4.3%, and 69.4% +/- 5.7%, respectively. The mean of percent area of neovascularization in the 2% doxycycline (pH neutralized) doxycycline group was significantly less than that of the control group and the <1% doxycycline concentrations (P < 0.05). The percent corneal neovascularization in the 2% (pH neutralized) doxycycline group was not significantly different from that of the 1% and 2% doxycycline groups (P < 0.05). There was no significant difference in percent area of corneal scar between control and study groups (P > 0.05). The mean percent area of corneal neovascularization in triamcinolone acetonide and LMWH, triamcinolone acetonide and doxycycline, and control groups was 2.35% +/- 4.42%, 9.42% +/- 6.8%, and 64.7% +/- 10.0%, respectively. The mean percent area of neovascularization in the triamcinolone acetonide plus LMWH or triamcinolone acetonide plus doxycycline groups was significantly different from that of the control group (P = 0.001 for both). There was no significant difference between study groups with regard to percent area of neovascularization or percent area of corneal scar between the control and study groups. CONCLUSIONS: Topically administered combinations of triamcinolone acetonide plus LMWH or triamcinolone acetonide plus doxycycline had effects that contributed to efficient suppression of corneal neovascularization; these drugs were ineffective at similar concentrations used alone. Topically administered 2% (pH neutralized) doxycycline has antiangiogenic effects, which contributed to significant suppression on corneal neovascularization. This drug may be therapeutically beneficial in treatment of corneal neovascularization in clinical trials.

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.

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.

Standardized analyses of correction of astigmatism with the visian toric phakic implantable collamer lens.

PURPOSE: To demonstrate the methodology described by the American National Standards Institute (ANSI) Standard Subcommittee on Astigmatism Analysis reporting a standardized method of presenting astigmatism data by laser systems that reshape the cornea also applies to toric phakic intraocular lens (IOL) data. METHODS: The U.S. Food and Drug Administration trial of the Visian Toric Implantable Collamer Lens comprised 210 eyes of 124 study patients. The mean preoperative manifest refraction spherical equivalent for the study cohort was -9.36 +/- 2.66 diopters (D) (range: -19.50 to -2.38 D). The mean preoperative manifest refractive cylinder was 1.94 +/- 0.84 D (range: 1.00 to 4.00 D). RESULTS: Data were arrayed using the 11 tables and 4 figures suggested in the Subcommittee paper. Interpretation of the data from a toric phakic IOL study was similar to that of laser refractive procedures. The addition of a table of manifest refractive cylinder (in the spectacle plane) over time, which provides a direct clinical measure of clinical efficacy, is suggested. Mean postoperative manifest refractive cylinder was 0.51 +/- 0.48 D (range: 0 to 3.00 D) with 65.6% of eyes having < or = 0.50 D of refractive cylinder at 12 months. A table of observed stability of the toric phakic IOL orientation within the eye obtained by slit-lamp examination also is recommended, which is a useful table not applicable in laser refractive procedures. CONCLUSIONS: The data presented demonstrate that the methodology developed by the ANSI Standard Subcommittee on Astigmatism Analysis, with some minor additions, accurately characterizes the efficacy of toric phakic IOLs in treating astigmatism.

Matched population comparison of the Visian Implantable Collamer Lens and standard LASIK for myopia of -3.00 to -7.88 diopters.

PURPOSE: To compare matched populations of LASIK and Visian Implantable Collamer Lens (ICL) cases in the correction of myopia between -3.00 and -7.88 diopters (D). METHODS: One hundred sixty-four LASIK eyes with prospective data collected from a single center and 164 ICL eyes from the multicenter US ICL Clinical Trial were compared in this observational non-randomized study. The LASIK and ICL groups were well matched for age, gender, and mean level of preoperative spherical equivalent refraction. RESULTS: At 6 months, best spectacle-corrected visual acuity (BSCVA) > or = 20/20 was 85% with LASIK and 95% with ICL (P = .003) compared to preoperative values of 93% and 88%, respectively (P = .292). Loss of > or = 2 lines of BSCVA was significantly lower with the ICL at 1 week (0.6% vs 10%, P < .001) and 1 month (7% vs 0%, P = .001) with comparable outcomes at 6 months (0% vs 1%). At 6 months postoperatively, uncorrected visual acuity (UCVA) > or = 20/15 (11% vs 25%, P = .001) and > or = 20/20 (49% vs 63%, P = .001) was better in the ICL cases. Predictability within 0.50 D at 6 months for ICL cases was 85% (67% LASIK, P < .001); 97% of ICL cases were within 1.00 D (88% LASIK, P = .002). Refractive stability (+/- 0.50 D) between 1 and 6 months was 93% with ICL compared to only 82% with LASIK (P = .006). CONCLUSIONS: The ICL performed better than LASIK in almost all measures of safety, efficacy, predictability, and stability in this matched population comparison, supporting the ICL as an effective alternative to existing refractive laser surgical treatments for the range of myopia studied.

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.