Correction of Moderate to High Myopia with a Foldable, Angle-Supported Phakic Intraocular Lens: Results from a 5-Year Open-Label Trial.

PURPOSE: To evaluate the 5-year efficacy of a foldable, hydrophobic, angle-supported phakic intraocular lens (pIOL) when used to correct moderate to high myopia. DESIGN: Prospective, nonrandomized, multicenter, open-label cohort study conducted in the United States, the European Union, and Canada (3 separate protocols). PARTICIPANTS: This was a pooled analysis of 515 eyes from 360 patients 18 to 49 years of age with moderate to high myopia (preoperative corrected distance visual acuity [CDVA] ≤0.34 logarithm of the minimum angle of resolution [logMAR]) and with variance in the manifest refraction spherical equivalent within ±0.5 diopter (D) for a minimum of 12 months. INTERVENTION: Implantation of the AcrySof Cachet angle-supported anterior chamber pIOL (Alcon Laboratories, Inc., Fort Worth, TX). MAIN OUTCOME MEASURES: Uncorrected distance visual acuity (UDVA), CDVA, predictability and stability of manifest refraction spherical equivalent (MRSE), serious adverse events, endothelial cell density, and patient satisfaction. RESULTS: Of 360 patients who received implantation in at least 1 eye (515 eyes), 326 (90.6%) completed the study (5-year best-corrected visual acuity data available for 415 eyes). At 5 years, a decrease in CDVA of 2 lines or more was observed in 0.5% of eyes (n = 2/415) compared with preoperative baseline. At 5 years, all 415 eyes achieved a CDVA of 0.34 logMAR or less; 91.3% (n = 379/415) had a CDVA of 0.04 logMAR or less. Mean UDVA ± standard deviation (SD) was 0.01±0.18 logMAR; 94.7% (n = 393/415) and 66.3% (n = 275/415) of eyes had a UDVA of 0.34 logMAR or less or 0.04 logMAR or less, respectively, at 5 years. Mean MRSE ± SD was -0.34±0.57 D (range,-2.50 to 1.63 D). Most eyes (89.8%; n = 371/413) had an MRSE within ±1.00 D of their target refractive error at 5 years and 67.3% (n = 278/413) were within ±0.50 D. Mean annualized central endothelial cell loss was 1.46% (90% confidence interval [CI], -1.6% to -1.3%) from 6 months to 5 years. The most common pIOL-related serious adverse event was adhesion between the cornea and the iris (synechia; n = 24). Most patients (98.1%) indicated that they would have the same pIOL implanted again. CONCLUSIONS: In patients with moderate to high myopia, the AcrySof Cachet angle-supported pIOL provided excellent refractive correction for up to 5 years after implantation, with a low rate of mean central endothelial cell loss. Careful patient selection is necessary to achieve optimal postsurgical outcomes.

Reduced effect of glare disability on driving performance in patients with blue light-filtering intraocular lenses.

PURPOSE: To compare the effects of glare on driving performance in patients who had implantation of a blue light-filtering acrylic intraocular lens (IOL) and those who had implantation of an acrylic IOL with no blue-light filter. SETTING: Department of Applied Psychology, Arizona State University, Mesa, Arizona, USA. DESIGN: Cross-sectional study. METHODS: Patients with a blue light-filtering AcrySof Natural SN60AT IOL (study group) and patients with an AcrySof SA60AT IOL with no blue-light filter (control group) who had good visual acuity and a valid driver's license performed left-turn maneuvers in a driving simulator in front of oncoming traffic. The safety margin (time to collision minus time taken to turn at intersection with oncoming traffic) was calculated. The measurements were repeated with a glare source simulating low-angle sun conditions (daytime driving). RESULTS: With glare, the safety margin was statistically significantly greater in the study group (n = 17) than in the control group (n = 17) (mean 2.534 seconds ± 0.488 [SD] and 2.116 ± 0.511 seconds, respectively) (P < .05). Comparing no-glare conditions and glare conditions, the study group had significantly lower glare susceptibility, fewer collisions with the oncoming car, and a lower impact on intersection approach speed than the control group. CONCLUSIONS: The IOL incorporating blue light-filtering technology significantly reduced glare disability and improved the driver's ability to safely execute a left turn with oncoming traffic in the presence of glare simulating low-angle sun conditions. The real-world benefit of this technology is presumably mediated by a stronger signal to detect approaching objects (motion-in-depth) as a result of a reduction in glare disability. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned. Additional disclosures are found in the footnotes.

Functional outcomes after bilateral implantation of apodized diffractive aspheric acrylic intraocular lenses with a +3.0 or +4.0 diopter addition power Randomized multicenter clinical study.

PURPOSE: To evaluate functional outcomes after bilateral implantation of apodized diffractive aspheric acrylic intraocular lenses (IOLs) with a +3.0 or +4.0 diopter (D) addition (add) power. SETTING: Twelve study centers in the United States. METHODS: This randomized patient-masked parallel-group 6-month follow-up study comprised patients having bilateral cataract extraction with implantation of an AcrySof IQ ReSTOR SN6AD3 IOL with a +4.0 D add power (+4.0 D group) or an AcrySof IQ ReSTOR SN6AD1 IOL with a +3.0 D add power (+3.0 D group) (both IOLs, Alcon, Inc.). Visual acuity, defocus testing, patient-reported outcomes, and safety measures were assessed. RESULTS: Of the 279 patients, 141 were in the +3.0 D group and 138 were in the +4.0 D group. Binocular distance-corrected intermediate visual acuity was statistically significantly better in the +3.0 D group than in the +4.0 D group (P<.0001); there was no difference in binocular near or distance visual acuity. There were no statistically significant differences in visual disturbances between the 2 groups. Patients in both groups reported excellent overall spectacle independence, near visual function, and satisfaction with the IOLs. CONCLUSIONS: Intermediate vision at a mean reading distance of approximately 40 cm was better with the aspheric IOL with a +3.0 D add than with the aspheric IOL with a +4.0 D add, as shown by the near peak in the mean binocular defocus curve; near and distance acuity were similar between the 2 IOLs. Patients reported excellent overall quality of vision, spectacle independence, and satisfaction.

Performance of presbyopia-correcting intraocular lenses in distance optical bench tests.

PURPOSE: To compare the optical performance of 6 presbyopia-correcting intraocular lenses (IOLs) of different designs (accommodating or multifocal and aspheric or spheric). SETTING: Alcon Laboratories, Inc., Fort Worth, Texas, USA. METHODS: The optical performance of 6 IOLs were compared using modulation transfer function (MTF) and the United States Air Force 1951 Resolution Target (AFT) testing. The IOLs included 3 spheric designs (Crystalens AT-50SE, AcrySof ReSTOR SA60D3, and ReZoom NXG1) and 3 aspheric designs (AcrySof ReSTOR SN6AD3, Acri.Lisa 366D, and Tecnis ZM900). Tests were performed with a modified International Organization for Standardization (ISO) model eye with a 5.0 mm aperture at the distance focus. RESULTS: The ReSTOR aspheric IOL had the highest MTF values at all spatial frequencies, and the ReZoom IOL had the lowest MTF values at most spatial frequencies. The ReSTOR aspheric IOL produced the image with the highest resolution on the AFT test; the Tecnis and the ReZoom IOLs produced the images with the poorest resolution. The Acri.Lisa multifocal IOL was second to the ReSTOR aspheric IOL on the MTF test and had high resolution on the AFT test. The accommodating Crystalens performed poorly on the MTF test but had the second highest resolution on the AFT test. CONCLUSIONS: The AcrySof ReSTOR SN6AD3 aspheric IOL showed superior optical properties, demonstrated in MTF and AFT optical bench testing, among 6 presbyopia-correcting IOLs including the monofocal accommodating Crystalens. The Acri.Lisa IOL also performed well. The ReZoom IOL demonstrated the poorest overall optical quality.

Nepafenac dosing frequency for ocular pain and inflammation associated with cataract surgery.

PURPOSE: Nepafenac ophthalmic suspension 0.1% was dosed topically once (QD), twice (BID), or three-times (TID) daily to assess the resolution of ocular pain and anterior-segment inflammation following cataract surgery. METHODS: This was a prospective, multicenter, double-masked, randomized, placebo-controlled study of 212 adults. Patients received nepafenac 0.1% or placebo, 1 drop QD, BID, or TID beginning 1 day before cataract surgery, continuing on the day of surgery, and for 14 days thereafter. One (1) additional drop was administered 30-120 min prior to surgery. The primary efficacy endpoint was percent of treatment failures (>or=16 aqueous cells, aqueous flare = severe, or ocular pain score = moderately severe or severe) through postoperative day 14. RESULTS: On days 7 and 14, the QD, BID, and TID all nepafenac posologies significantly reduced the percent of treatment failures, compared to placebo ( p

Clinical results of the blue-light filtering AcrySof Natural foldable acrylic intraocular lens.

PURPOSE: To verify the safety and effectiveness of the new AcrySof Natural (Alcon Laboratories, Inc.) blue-light filtering intraocular lens (IOL), which was designed to achieve a light-transmission spectrum similar to that of the natural human crystalline lens. SETTING: Multicenter U.S. clinical trial. METHODS: In a prospective randomized patient-masked multicenter study, 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. RESULTS: No statistically significant differences were discovered between the 2 patient groups in visual acuity, 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. CONCLUSIONS: The blue-light filtering AcrySof Natural IOL was equivalent to the conventional AcrySof lens in terms of postoperative visual performance. Additional long-term clinical studies should show whether the IOL actually provides the theoretical benefits to retinal health.