Patient-Reported Outcomes/Satisfaction and Spectacle Independence with Blended or Bilateral Multifocal Intraocular Lenses in Cataract Surgery.

PURPOSE: To compare patient-reported outcomes (PROs) and satisfaction results after multifocal intraocular lens (IOL) implantation in three groups: two receiving bilateral implantation of the same IOL and another undergoing blended vision with two different multifocal IOLs. PATIENTS AND METHODS: A questionnaire was administered to patients who had undergone uncomplicated cataract surgery and 2 months of follow-up: the first group underwent bilateral implantation with Alcon's AcrySof ReSTOR 3.0 lens ("3.0/3.0," n=78); the second group underwent implantation with the ReSTOR ActiveFocus 2.5 or the ReSTOR ActiveFocus 2.5 toric lens ("2.5 mini-monovision," n=102); and the third group underwent implantation with the ReSTOR 2.5 lens in the dominant eye and the ReSTOR 3.0 lens in the non-dominant eye ("2.5/3.0," n=89). RESULTS: Overall PROs and satisfaction was similar among the groups. Refractive outcomes and accuracy were similar among the groups, but the 2.5 mini-monovision group reported better intermediate vision. Refractive outcome differences were not meaningful among the groups and were not a differentiating factor in PROs. Substantially fewer patients in the 2.5 mini-monovision group noticed glare and halo compared with the 3.0/3.0 group (P<0.0001, chi-square test). No new safety concerns were reported. CONCLUSION: The 2.5 mini-monovision results in a higher percentage of patients being satisfied with intermediate vision than bilateral ReSTOR 3.0 or blended vision with ReSTOR 2.5/3.0 implants, but overall PRO differences were not statistically significant.

A meta-analysis of Nd:YAG capsulotomy rates for two hydrophobic intraocular lens materials.

PURPOSE: The purpose of this study is to estimate and compare neodymium-doped yttrium aluminum garnet (Nd:YAG) capsulotomy rates for AcrySof ® and Clareon® intraocular lens (IOL) materials using historical data from the medical literature and Alcon-sponsored clinical studies. METHODS: Clinical trials that involved the implantation of AcrySof or Clareon monofocal IOLs in subjects with cataract or presbyopia were extracted from the literature and a company repository of clinical studies. The study duration, number of eyes, and cumulative percent of Nd:YAGs for posterior capsule opacification were extracted. Bayesian random effects meta-analyses were conducted to estimate and compare outcomes for the 2 different IOL materials. RESULTS: A Bayesian random effects, meta-analysis was performed that combined a literature review of published AcrySof Nd:YAG posterior capsulotomy rates and Nd:YAG rates observed in Alcon-sponsored clinical studies of AcrySof and Clareon. Sixteen Alcon studies contained Nd:YAG data suitable for meta-analysis. Three of these Alcon studies contained results for the Clareon material (2 one-year studies, and 1 three-year study). The literature review included 50 papers from 1998 to 2015. In combination, 30,891 eyes were available for analysis and 2040 Nd:YAG procedures were reported in studies with a follow-up duration ranging in length from 4 months to 10 years. The overall probability of performing a Nd:YAG capsulotomy within a year of implant for AcrySof was 1.44% (1.11% to 1.83%) and 0.62% (0.21% to 1.38%) for Clareon. There was small improvement in the probability of Nd:YAG within a year of implant for Clareon lenses of about 0.82% with a 95% credible interval of (0.07% to 1.36%) at 1 year. Results were similar for incidence rates per 100 surgeries in a year: 0.62 (0.21 to 1.40) for Clareon, 1.46 (1.12 to 1.87) for AcrySof, and the difference was 0.84 (0.07 to 1.39) favoring Clareon. At 3 years, the overall probability of performing a Nd:YAG capsulotomy for AcrySof was 4.19% (3.24% to 5.30%) compared with only 1.82% (0.63% to 4.02%) for Clareon. CONCLUSION: A meta-analysis of Clareon multi-piece and single-piece clinical data predicts that the cumulative Clareon Nd:YAG probability will be ≤ AcrySof by 2.37% (0.18% to 3.91%) at 3 years. The results indicate that Clareon is likely to perform as well as, and possibly better than, AcrySof in terms of Nd:YAG capsulotomy rates.

Comparison of stability between a modular intraocular lens system and a single-piece hydrophobic acrylic intraocular lens.

PURPOSE: To compare the movement of a modular intraocular lens (IOL) with that of a standard single-piece hydrophobic acrylic IOL in a human cadaver eye perfusion model. SETTING: Department of Ophthalmology, University of Colorado, Aurora, Colorado, USA. DESIGN: Experimental study. METHODS: Eight phakic human donor eyes of 4 patients had standard phacoemulsification with lens removal. One of 2 IOLs was then implanted in the capsular bag: a modular IOL (Harmoni) or a standard single-piece IOL (Acrysof SN60). Each globe was connected to a programmable perfusion pump with an in-line pressure transducer. Ultrasound biomicroscopy (UBM) was used to evaluate the anterior chamber depth (ACD) in each eye, measuring from the posterior cornea to the anterior surface of the optic at an intraocular pressure (IOP) of 5 mm Hg, 10 mm Hg, 20 mm Hg, and 30 mm Hg. Five consecutive measurements were recorded for all eyes at each pressure, and the results were averaged. RESULTS: There was significantly less movement in eyes with the modular IOL than in eyes with the single-piece IOL. The mean position of the modular IOL varied from a minimum of 0.03 mm to a maximum of 0.07 mm, and the mean position of the single-piece IOL varied from a minimum of 0.26 mm to a maximum of 0.87 mm (P = .002). CONCLUSIONS: The modular IOL showed less movement with changes in IOP than a standard single-piece IOL. Improved IOL stability might allow more accuracy in determining the effective lens position and hence improve the predictability of the refractive target. FINANCIAL DISCLOSURE: Proprietary or commercial disclosures are listed after the references.

Effect of Oral Re-esterified Omega-3 Nutritional Supplementation on Dry Eyes.

PURPOSE: To assess the effect of oral re-esterified omega-3 fatty acids on tear osmolarity, matrix metalloproteinase-9 (MMP-9), tear break-up time (TBUT), Ocular Surface Disease Index (OSDI), fluorescein corneal staining, Schirmer score, meibomian gland dysfunction (MGD) stage and omega-3 index in subjects with dry eyes and confirmed MGD. METHODS: This was a multicenter, prospective, interventional, placebo-controlled, double-masked study. Subjects were randomized to receive 4 softgels containing a total of 1680 mg of eicosapentaenoic acid/560 mg of docosahexaenoic acid or a control of 3136 mg of linoleic acid, daily for 12 weeks. Subjects were measured at baseline, week 6, and week 12 for tear osmolarity, TBUT, OSDI, fluorescein corneal staining, and Schirmer test with anesthesia. MMP-9 testing and omega-3 index were done at baseline and at 12 weeks. RESULTS: One hundred five subjects completed the study. They were randomized to omega-3 (n = 54) and control group (n = 51). Statistically significant reduction in tear osmolarity was observed in the omega-3 group versus control group at week 6 (-16.8 ± 2.6 vs. -9.0 ± 2.7 mOsm/L, P = 0.042) and week 12 (-19.4 ± 2.7 vs. -8.3 ± 2.8 mOsm/L, P = 0.004). At 12 weeks, a statistically significant increase in omega-3 index levels (P < 0.001) and TBUT (3.5 ± 0.5 s vs. 1.2 ± 0.5 s, P = 0.002) was also observed. Omega-3 group experienced a significant reduction in MMP-9 positivity versus control group (67.9% vs. 35.0%, P = 0.024) and OSDI scores decreased significantly in omega-3 (-17.0 ± 2.6) versus control group (-5.0 ± 2.7, P = 0.002). CONCLUSIONS: Oral consumption of re-esterified omega-3 fatty acids is associated with statistically significant improvement in tear osmolarity, omega-3 index levels, TBUT, MMP-9, and OSDI symptom scores.

Lifitegrast clinical efficacy for treatment of signs and symptoms of dry eye disease across three randomized controlled trials.

OBJECTIVE: Report efficacy findings from three clinical trials (one phase 2 and two phase 3 [OPUS-1, OPUS-2]) of lifitegrast ophthalmic solution 5.0% for treatment of dry eye disease (DED). RESEARCH DESIGN AND METHODS: Three 84-day, randomized, double-masked, placebo-controlled trials. Adults (≥18 years) with DED were randomized (1:1) to lifitegrast 5.0% or matching placebo. Changes from baseline to day 84 in signs and symptoms of DED were analyzed. MAIN OUTCOME MEASURES: Phase 2, pre-specified endpoint: inferior corneal staining score (ICSS; 0-4); OPUS-1, coprimary endpoints: ICSS and visual-related function subscale (0-4 scale); OPUS-2, coprimary endpoints: ICSS and eye dryness score (EDS, VAS; 0-100). RESULTS: Fifty-eight participants were randomized to lifitegrast 5.0% and 58 to placebo in the phase 2 trial; 293 to lifitegrast and 295 to placebo in OPUS-1; 358 to lifitegrast and 360 to placebo in OPUS-2. In participants with mild-to-moderate baseline DED symptomatology, lifitegrast improved ICSS versus placebo in the phase 2 study (treatment effect, 0.35; 95% CI, 0.05-0.65; p = 0.0209) and OPUS-1 (effect, 0.24; 95% CI, 0.10-0.38; p = 0.0007). Among more symptomatic participants (baseline EDS ≥40, recent artificial tear use), lifitegrast improved EDS versus placebo in a post hoc analysis of OPUS-1 (effect, 13.34; 95% CI, 2.35-24.33; nominal p = 0.0178) and in OPUS-2 (effect, 12.61; 95% CI, 8.51-16.70; p < 0.0001). LIMITATIONS: Trials were conducted over 12 weeks; efficacy beyond this period was not assessed. CONCLUSIONS: Across three trials, lifitegrast improved ICSS in participants with mild-to-moderate baseline symptomatology in two studies, and EDS in participants with moderate-to-severe baseline symptomatology in two studies. Based on the overall findings from these trials, lifitegrast shows promise as a new treatment option for signs and symptoms of DED.

Hydrogel sealant versus sutures to prevent fluid egress after cataract surgery.

PURPOSE: To evaluate the effectiveness of a hydrogel sealant versus a suture in preventing fluid egress after wound leakage in cataract surgery. SETTING: Twenty-four ophthalmic clinical practices in the United States. DESIGN: Prospective randomized parallel-arm controlled multicenter subject-masked study. METHODS: Healthy patients having uneventful clear corneal incision (CCI) cataract surgery were eligible for the study. Spontaneous and provoked fluid egress from wounds was evaluated at the time of surgery using a calibrated force gauge. Eyes with leakage were randomized to receive a hydrogel sealant (Resure) or a nylon suture at the main incision site. Incision leakage was reevaluated 1, 3, 7, and 28 days postoperatively. RESULTS: Of 500 eyes, 488 had leakage at the time of cataract surgery. The leak was spontaneous in 244 cases (48.8%), and 488 (97.6%) of all incisions leaked with 1.0 ounce or less of applied force. After randomization, 12 (4.1%) of 295 eyes in the sealant group and 60 (34.1%) of 176 eyes in the suture group had wound leakage with provocation (P<.0001). The overall incidence of adverse ocular events was statistically significantly lower in the sealant group than in the suture group (P<.05). CONCLUSIONS: In this study, 97.6% of CCIs leaked after cataract surgery. The hydrogel sealant was safe and effective and better than a suture for the intraoperative management of CCIs with leakage as seen on Seidel testing and for the prevention of postoperative fluid egress.

Effect of loteprednol etabonate 0.5% on initiation of dry eye treatment with topical cyclosporine 0.05%.

OBJECTIVE: The purpose of this work was to evaluate the effect of loteprednol etabonate (LE) before the initiation of topical cyclosporine A (tCsA) therapy in patients with mild-to-moderate dry eye disease. Prospective, multicenter randomized double-masked parallel group clinical study (NCT00407043). METHODS: Hundred and eighteen patients with dry eye disease were randomized to receive either LE and tCsA (n=61) or artificial tears (AT) and tCsA (n=57). Hundred and twelve patients completed the study (LE: n=57, AT: n=55) and are included in the data analysis. Patients self-administered either LE or AT for 2 weeks 4 times per day, followed by tCsA twice per day accompanied by either LE twice per day or AT twice per day for an additional 6 weeks of treatment. Primary outcome measures included the Ocular Surface Disease Index (OSDI) questionnaire, the Likert scale using standardized facial expressions, lissamine green staining, fluorescein staining, and the Schirmer test. Additional measures included global self-assessment, and safety outcomes included slitlamp examination, intraocular pressure, and assessment of visual acuity. RESULTS: Loteprednol etabonate pretreatment significantly reduced tCsA stinging (P<0.05). Both groups showed significantly improved OSDI scores at the 14-, 30-, and 60-day visits. Loteprednol etabonate showed significantly more OSDI improvement than AT. Both pretreatment strategies improved global self-assessment scores, Schirmer test, fluorescein staining, lissamine staining, and adjunctive AT use. Loteprednol etabonate showed superior improvement in Schirmer test, fluorescein staining, and lissamine staining. Intraocular pressure did not increase in either group. CONCLUSIONS: Loteprednol etabonate induction therapy 2 weeks before the initiation of long-term tCsA treatment for chronic dry eye disease provides more rapid relief of dry eye signs and symptoms with greater efficacy than tCsA and AT alone.

Development of a non-settling gel formulation of 0.5% loteprednol etabonate for anti-inflammatory use as an ophthalmic drop.

The eye has protective barriers (ie, the conjunctival and corneal membranes) and defense mechanisms (ie, reflex tearing, blinking, lacrimal drainage) which present challenges to topical drug delivery. Topical ocular corticosteroids are commonly used in the treatment of anterior segment diseases and inflammation associated with ocular surgery, and manufacturers continually strive to improve their characteristics. We describe the development of a novel ophthalmic gel formulation of loteprednol etabonate (LE), a C-20 ester-based corticosteroid with an established safety profile, in the treatment of ocular inflammatory conditions. The new LE gel formulation is non-settling, eliminating the need to shake the product to resuspend the drug, has a pH close to that of tears, and a low preservative concentration. The rheological characteristics of LE gel are such that the formulation is instilled as a drop and transitions to a fluid upon instillation in the eye, yet retains sufficient viscosity to prolong ocular surface retention. The new formulation provides consistent, uniform dosing as evidenced by dose extrusion studies, while pharmacokinetic studies in rabbits demonstrated rapid and sustained exposure to LE in ocular tissues following instillation of LE gel. Finally, results from two clinical studies of LE gel in the treatment of postoperative inflammation and pain following cataract surgery indicate that it was safe and effective. Most patients reported no unpleasant drop sensation upon instillation, and reports of blurred vision were rare.

Loteprednol etabonate 0.5% versus prednisolone acetate 1.0% for the treatment of inflammation after cataract surgery.

PURPOSE: To evaluate the efficacy of loteprednol etabonate 0.5% versus prednisolone acetate 1.0% for the control of postoperative inflammation in patients having routine cataract surgery. SETTING: Private practice, Stillwater, Minnesota, and Cincinnati Eye Institute, Cincinnati, Ohio, USA. DESIGN: Comparative case series. METHODS: Patients were at least 18 years of age and scheduled for routine cataract surgery. Patients were excluded from the study if they had preexisting medical conditions (ie, elevated intraocular pressure [IOP], retinopathy, maculopathy, uveitis) or required medications the investigator believed would put the patient at risk or confound the study. Patients were randomized to receive loteprednol etabonate or prednisolone acetate 4 times daily in addition to bromfenac 0.09% and besifloxacin 0.6% after surgery. Visual acuity, IOP, and anterior chamber cell and flare intensity were assessed over 3 weeks after cataract surgery. The primary endpoint was the level of anterior chamber cell and flare intensity in patients treated with loteprednol etabonate or prednisolone acetate. RESULTS: The study enrolled 88 patients (46 loteprednol etabonate, 42 prednisolone acetate). Equivalency was achieved between the 2 treatment groups with no significant differences throughout the 3-week follow-up. There was less fluctuation in IOP assessments in patients treated with loteprednol etabonate than in patients treated with prednisolone acetate, in particular 1 day and 3 days postoperatively. CONCLUSIONS: The results indicate that equivalent control of inflammation can be obtained through treatment with loteprednol etabonate or prednisolone acetate after cataract surgery. In addition, treatment with loteprednol etabonate may result in less IOP fluctuation. FINANCIAL DISCLOSURE: Dr. Lane is a consultant to Bausch & Lomb, Rochester, New York, Alcon Laboratories, Inc., Fort Worth, Texas, and ISTA Pharmaceuticals, Irvine, California, USA. Dr. Holland is a consultant to Bausch & Lomb, Rochester, New York, and Alcon Laboratories, Inc., Fort Worth, Texas, USA. Neither author has a financial or proprietary interest in any material or method mentioned.

A new system, the LipiFlow, for the treatment of meibomian gland dysfunction.

PURPOSE: To evaluate the safety and effectiveness of the LipiFlow System compared to the iHeat Warm Compress (WC) for adults with meibomian gland dysfunction (MGD). METHODS: This was a non-significant risk, prospective, open-label, randomized, crossover multicenter clinical trial. One hundred thirty-nine subjects were randomized between LipiFlow (n=69) and WC control (n=70). Subjects in the LipiFlow group received a 12-minute LipiFlow treatment and were reexamined at 1 day, 2 weeks and 4 weeks. Control subjects received a 5-minute iHeat treatment with instructions to perform the same treatment daily for 2 weeks. At 2 weeks, they crossed over (LipiFlow Crossover) and received the LipiFlow treatment. Effectiveness parameters: meibomian gland (MG) assessment, tear break-up time (TBUT) and dry eye symptoms. Safety parameters: adverse events, ocular health exam, ocular surface staining, intraocular pressure, visual acuity and discomfort. RESULTS: LipiFlow resulted in significant improvement (P < 0.05) in MG secretion at 2 and 4 weeks (mean ± standard deviation at baseline = 6.3 ± 3.5; 2 weeks = 14.3 ± 8.7; 4 weeks = 16.7 ± 8.7); and TBUT at 2 and 4 weeks: (at baseline = 5.5 ± 2.9; 2 weeks = 6.9 ± 5.0; 4 weeks = 7.4 ± 5.5). There was no significant change in MG secretion or TBUT in the control group. LipiFlow resulted in a greater significant reduction in dry eye symptoms than the iHeat WC. The crossover group demonstrated similar significant improvement 2 weeks post-treatment with the LipiFlow. There was no significant difference between groups in the incidence of non-serious, device-related adverse events. CONCLUSION: The LipiFlow System was significantly more effective than iHeat WC. These results support its safety and effectiveness in the treatment of MGD and dry eye symptoms.

Comparative effectiveness and cost-effectiveness of the implantable miniature telescope.

OBJECTIVE: To assess the preference-based comparative effectiveness (human value gain) and the cost-utility (cost-effectiveness) of a telescope prosthesis (implantable miniature telescope) for the treatment of end-stage, age-related macular degeneration (AMD). DESIGN: A value-based medicine, second-eye model, cost-utility analysis was performed to quantify the comparative effectiveness and cost-effectiveness of therapy with the telescope prosthesis. PARTICIPANTS: Published, evidence-based data from the IMT002 Study Group clinical trial. Ophthalmic utilities were obtained from a validated cohort of >1000 patients with ocular diseases. METHODS: Comparative effectiveness data were converted from visual acuity to utility (value-based) format. The incremental costs (Medicare) of therapy versus no therapy were integrated with the value gain conferred by the telescope prosthesis to assess its average cost-utility. The incremental value gains and incremental costs of therapy referent to (1) a fellow eye cohort and (2) a fellow eye cohort of those who underwent intra-study cataract surgery were integrated in incremental cost-utility analyses. All value outcomes and costs were discounted at a 3% annual rate, as per the Panel on Cost-Effectiveness in Health and Medicine. MAIN OUTCOME MEASURES: Comparative effectiveness was quantified using the (1) quality-adjusted life-year (QALY) gain and (2) percent human value gain (improvement in quality of life). The QALY gain was integrated with incremental costs into the cost-utility ratio ($/QALY, or US dollars expended per QALY gained). RESULTS: The mean, discounted QALY gain associated with use of the telescope prosthesis over 12 years was 0.7577. When the QALY loss of 0.0004 attributable to the adverse events was factored into the model, the final QALY gain was 0.7573. This resulted in a 12.5% quality of life gain for the average patient during the 12 years of the model. The average cost-utility versus no therapy for use of the telescope prosthesis was $14389/QALY. The incremental cost-utility referent to control fellow eyes was $14063/QALY, whereas the incremental cost-utility referent to fellow eyes that underwent intra-study cataract surgery was $11805/QALY. CONCLUSIONS: Therapy with the telescope prosthesis considerably improves quality of life and at the same time is cost-effective by conventional standards.

Correction of high myopia with a phakic intraocular lens: interim analysis of clinical and patient-reported outcomes.

PURPOSE: To assess uncorrected distance visual acuity (UDVA) and patient-reported outcome changes after bilateral anterior chamber angle-fixated phakic intraocular lens (pIOL) implantation for high myopia. SETTING: Multiple North American surgical centers. DESIGN: Nonrandomized multicenter clinical trials. METHODS: This was a pooled interim analysis of 2 open-label single-arm studies of high myopia patients with bilateral anterior chamber angle-fixated pIOLs. Assessments compared baseline with 6-month, 1-year, and 2-year measurements. Outcomes included binocular UDVA, binocular corrected distance visual acuity (CDVA), satisfaction with vision, spectacle independence, and Refractive Status and Vision Profile (RSVP) questionnaire results. RESULTS: One hundred thirty-eight patients (mean age 37 years, 67% women) completed all 4 assessments. The UDVA at 6 months, 1 year, and 2 years postoperatively was statistically better than the baseline CDVA (0.12 logMAR, 0.11 logMAR, 0.12 logMAR, respectively, versus 0.06 logMAR) (P<.005). The increase in preoperative to postoperative satisfaction with uncorrected vision was significant (P<.0001). Distance vision spectacle independence improved from 0% preoperatively to 94% postoperatively (P<.0001). Patients reported significant improvements in the RSVP overall score (P<.0001) and the following 7 subscales: concern with vision (P<.0001), driving (P<.001), problems with glare (P<.05), optical problems (P ≤.001), physical/social functioning (P<.0001), problems with corrective lenses (P<.005), and ocular symptoms (P<.0001). CONCLUSIONS: After pIOL implantation, the UDVA was better than the preoperative CDVA and most patients required no distance vision correction, had improved satisfaction with uncorrected vision, and had improved vision-related quality of life.

Angle-supported phakic intraocular lens for correction of moderate to high myopia: Three-year interim results in international multicenter studies.

PURPOSE: To evaluate the safety and effectiveness of an angle-supported phakic intraocular lens (pIOL) for correction of moderate to high myopia. SETTING: Ophthalmology centers in the United States, Canada, and the European Union. DESIGN: Cohort study. METHODS: This study comprised patients with moderate to high myopia (range -6.00 to -16.50 diopters [D]) who had implantation of the AcrySof Cachet pIOL. Outcome measures included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), predictability, stability of the manifest refraction spherical equivalent (MRSE), adverse events, and endothelial cell density (ECD). RESULTS: Pooled interim data from 360 patients assessed for up to 3 years postoperatively are presented. Of the 104 patients who reached the 3-year visit, the UDVA was 20/40 or better in 101 (97.1%) and 20/20 or better in 48 (46.2%). The CDVA was 20/32 or better in 103 (99.0%) of the 104 patients and 20/20 or better in 84 patients (80.8%). The mean MRSE was -0.24 D ± 0.55 (SD) (range -2.00 to 1.63 D). The residual refractive error was within ±0.50 D of target in 82 patients (78.8%) and within ±1.00 D in 95 patients (91.3%). The annualized percentage loss in central ECD and peripheral ECD from 6 months to 3 years was 0.41% and 1.11%, respectively. No pupil ovalization, pupillary block, or retinal detachment was observed. CONCLUSIONS: Three-year findings from pooled global studies showed that the angle-supported pIOL provided favorable refractive correction and predictability and acceptable safety in patients with moderate to high myopia.

Improving accuracy of phakic intraocular lens sizing using high-frequency ultrasound biomicroscopy.

PURPOSE: To assess the efficacy of high-frequency ultrasound biomicroscopy (UBM) in improving the accuracy of phakic intraocular lens (pIOL) sizing by increasing the incidence of acceptable postoperative vault. SETTING: Multiple private practices, United States. DESIGN: Evaluation of diagnostic test or technology. METHODS: This prospective multicenter clinical study evaluated eyes having pIOL (Visian Implantable Collamer Lens) implantation. A retrospective data analysis was performed using UBM measurements (VuMax-II) of preoperative sulcus-to-sulcus (STS) distance and postoperative vault. The regression data and clinical input from investigators were then used to develop a pIOL sizing nomogram. The nomogram used only STS and pIOL power as variables to determine length. Inadequate vault (<90 µm) and excessive vault (>1000 µm) were defined based on peer-reviewed literature. Sizing recommendations using the nomogram were studied prospectively and compared with 2 sizing methods used in the United States that are based on white-to-white (WTW) measurements. RESULTS: One eye was excluded from the analysis because the wrong length pIOL was placed (12.6 mm instead of nomogram-recommended 13.2 mm), resulting in 51 µm of vault. The mean postoperative vault in the remaining 72 cases was 340 µm ± 174 (SD) (range 90 to 952 µm); there were no cases of inadequate or excessive vault with the newly developed UBM nomogram. Sizing methods using WTW measurements would have resulted in different-sized pIOLs in 36% to 69% of cases compared with the STS method. CONCLUSION: There were no cases of inadequate or excessive vault when the UBM nomogram for pIOL sizing was used. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.

Improvements in patient-reported outcomes and visual acuity after bilateral implantation of multifocal intraocular lenses with +3.0 diopter addition: multicenter clinical trial.

PURPOSE: To assess changes in patient-reported outcomes, satisfaction, vision quality, and visual acuity after bilateral implantation of multifocal intraocular lenses (IOLs) with a 3.00 D addition (add) in cataract patients. SETTING: Twelve study centers, United States. DESIGN: Randomized multicenter clinical trial. METHODS: In this 6-month trial, cataract patients had bilateral implantation of the AcrySof IQ ReSTOR +3.0 IOL (model SN6AD1). Patient-reported outcomes were collected using the Cataract TyPE questionnaire. Clinical outcomes included uncorrected near (UNVA), uncorrected intermediate (UIVA), and uncorrected distance (UDVA) visual acuities. RESULTS: The study comprised 147 patients. From preoperatively to 6 months postoperatively, the mean UDVA improved from 0.45 logMAR (approximate Snellen, 20/56) to 0.04 logMAR (20/22 Snellen), the mean UIVA from 0.56 logMAR (20/73) to 0.17 logMAR (20/30), and the mean UNVA from 0.62 logMAR (20/83) to 0.10 logMAR (20/25); all improvements were clinically and statistically significant (P<.0001). There was also a statistically significant improvement in patient satisfaction with uncorrected vision (P<.0001). Clinically and statistical significant reductions occurred in trouble with vision (daytime and nighttime), trouble with glare, limitations with UDVA, limitations with UNVA, and limitations in social activities (P<.0001). CONCLUSIONS: Bilateral implantation of multifocal intraocular lenses (IOLs) with a 3.00 D add produced statistically significant and clinically relevant postoperative improvements in UNVA, UIVA, and UDVA. Commensurate significant postoperative improvements were observed in the patient-reported uncorrected functional vision, satisfaction with uncorrected vision, and social activities.

Comparison of clinical and patient-reported outcomes with bilateral AcrySof toric or spherical control intraocular lenses.

PURPOSE: To compare clinical and patient-reported outcomes with bilateral implantation of AcrySof toric or spherical control (Alcon Laboratories Inc) intraocular lenses (IOLs). METHODS: Patients with cataract and corneal astigmatism who previously received either an AcrySof toric IOL or an AcrySof spherical control IOL were offered implantation of the same IOL in the fellow eye. Six-month assessments included visual acuity, refractive cylinder, spectacle use, and patient satisfaction. RESULTS: The study included 62 patients (toric, n=40; control, n=22). All corneal incisions were temporal, with final mean incision sizes of 3.0 mm for the toric IOL and 3.1 mm for the spherical control IOL. A significantly greater proportion of patients with toric IOLs achieved spectacle independence for distance vision and did not require prescription glasses for near or distance vision (P=.0190). Patients with toric IOLs had significantly less residual refractive cylinder (P<.0001) and better binocular distance uncorrected visual acuity (UCVA) (P=.0014) than those with spherical control IOLs. CONCLUSIONS: Patients with bilateral AcrySof toric IOLs achieved superior spectacle freedom, residual refractive cylinder, and distance UCVA compared to patients with bilateral spherical control IOLs.

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.