Quality of vision clinical outcomes for a new fully-refractive extended depth of focus Intraocular Lens.

BACKGROUND/OBJECTIVE: To evaluate the visual performance of a purely refractive extended depth of focus (EDF) intraocular lens (IOL). SUBJECTS/METHODS: A prospective, multi-center, randomized, subject/evaluator-masked study. Subjects were bilaterally implanted with the EDF test (Model ZEN00V, N = 60) or an enhanced monofocal control (Model ICB00, N = 57) IOL. Monocular corrected distance (CDVA), intermediate (DCIVA), near acuities (DCNVA) and patient reported visual symptoms were evaluated at the 6-month visit. Monocular mesopic contrast sensitivity (CS) and depth of focus (DOF) testing were assessed at 3 months. RESULTS: CDVA (Mean ± SD) was -0.06 ± 0.08 for test and -0.05 ± 0.08 logMAR for control groups. DCIVA was 0.13 ± 0.08 for test and 0.18 ± 0.14 logMAR for control groups (p = 0.0127). DCNVA was 0.37 ± 0.10 for test and 0.43 ± 0.16 logMAR for control groups (p = 0.0137). Test lens was statistically superior for intermediate and near. Overall, 91.7% (halos), 95.0% (starbursts) and 95.0% (glare) of test lens patients reported that they did not experience, were not bothered, or were slightly bothered by specific visual symptoms, compared to 98.2%, 100% and 96.5% in the control group. The DOF range over which monocular visual acuity was 0.20 logMAR or better was -1.6 D for the test lens. Mesopic CS was comparable between both groups, falling within 0.11 log units for all measured cycles per degree with and without glare. CONCLUSION: The EDF IOL demonstrated extended range of vision and statistically superior intermediate and near performance compared to the monofocal IOL. Distance visual acuity, contrast sensitivity and dysphotopsia profile were similar to the monofocal IOL.

Three-year multinational clinical study on an aspheric hydrophobic acrylic intraocular lens.

PURPOSE: To present the results of a study investigating the 3-year effectiveness and safety of the Clareon single-piece intraocular lens (IOL). SETTING: 19 multinational sites. DESIGN: Prospective multicenter single-arm study. METHODS: Patients were bilaterally implanted with Clareon IOLs. Assessments included uncorrected distance visual acuity, corrected distance visual acuity (CDVA), manifest refraction, tilt, decentration, applanation tonometry, and fundus examination, including glistenings and posterior capsule opacification (PCO) evaluation. The primary outcomes for effectiveness and safety were evaluated at 1 year and compared with ISO historical safety and performance endpoint (SPE) rates. Patients were followed for up to 3 years after implantation. RESULTS: 424 eyes of 215 patients were implanted (n = 215 first eye, n = 209 second eye), and 183 patients completed the trial at 3 years (with 364 binocular and 1 monocular patient). At 1 year, the cumulative and persistent adverse event rates were below SPE targets, and 99.5% of eyes achieved a monocular CDVA of ≤0.3 logMAR (vs the SPE target of 92.5%). At 3 years, the mean monocular CDVA was -0.032, with 93.4% (341/365) of eyes achieving a CDVA of 0.1 logMAR or better, 100% of eyes presented with grade 0 glistenings ≤25 MV/mm 2 , and 92.9% of eyes (394/424) had either no PCO or clinically nonsignificant PCO. CONCLUSIONS: This study supports the long-term safety and effectiveness of the Clareon IOL. The visual outcomes were excellent and stable over the 3-year study period, PCO rates were very low, and 100% of IOLs had grade 0 glistenings.

Prevalence of visual impairment in older people living with dementia and its impact: a scoping review.

BACKGROUND AND OBJECTIVES: Visual impairment (VI) and dementia both increase with age, and it is likely that many older people are living with both conditions. This scoping review aims to investigate the prevalence and types of VI among older people living with dementia, and the impact of VI on older people living with dementia and their caregivers. METHODS: This scoping review used Arksey and O'Malley's methodological framework. Studies in any setting involving people living with dementia and some assessment of either VI, eye diseases causing VI or the impact of VI were included. RESULTS: Thirty-six studies were included. Thirty-one studies reported the prevalence of VI in older people living with dementia, while ten studies reported on impacts of VI on people living with dementia. Only one study reported on impacts on caregivers. The prevalence of VI or specific eye diseases among older people living with dementia ranged from 0.2 to 74%. The impacts of VI on older people living with dementia included increased use of hospital services, increased disability and dependency, reduced social engagement, negative emotions, increased abnormal behaviours, loss of hobbies, difficulty in using visual aids or memory aids, and greater Neuropsychiatric Inventory symptoms. And the impacts on caregivers included increased conflict and physical exhaustion. CONCLUSION: VI is common in older people living with dementia and is associated with negative impacts on those with dementia and their caregivers. However, heterogeneity between studies in terms of setting and method for assessing and defining VI make it difficult to compare findings among studies. Further research is needed, particularly assessing the impact on caregivers.

Visual and Refractive Efficacy of Panoptix Toric Intraocular Lens in a Clinical Setting.

Purpose: Trifocal Intraocular Lenses (IOLs) were developed to provide patients with effective near, intermediate and distance vision, thus minimizing spectacle dependency. Residual astigmatism has previously been shown to impact unaided visual acuity across all distances; therefore, to optimise the expected outcomes, consideration of preoperative corneal astigmatism is essential. The purpose of this study was to provide a real-world, multi-site review of visual and refractive outcomes in eyes undergoing implantation with the Panoptix Trifocal toric IOL platform. Patients and Methods: This study represents a two-fold approach. Patients who had previously undergone routine cataract removal and IOL insertion with the Panoptix Toric IOL were retrospectively analysed for routine efficacy and safety endpoints ("Retrospective Cohort"). Data was retrieved from the preoperative, surgical and postoperative visits (range 2-6 weeks). A further subset of patients undergoing lens removal and bilateral Panoptix Toric IOL insertion were identified at surgery ("Qualitative Cohort"). These patients underwent additional testing inclusive of quality of vision questionnaire and bilateral defocus curve. Results: A total of 466 eyes of 254 patients were included in the retrospective cohort. Between 91% and 98% of eyes, respectively, were within 0.50D and 1.00D of target. Mean absolute difference from Spherical Equivalent (SE) target was 0.22 ± 0.24Ds. Following surgery, 94% of eyes demonstrated a refractive astigmatism of 0.50D or less. Further, 61% eyes achieved uncorrected distance visual acuity (UDVA) of 20/20 or better, increasing to 94% achieving 20/32 or better. Seventy percent of eyes unilaterally achieved N5 unaided and 66.0% achieved N8 or better at intermediate. In the qualitative cohort, no patient described any symptom as significant or requested explant. Conclusion: In a real-world setting, the PanOptix toric trifocal IOL continues to demonstrate refractive accuracy and good visual performance at all focal distances. This IOL also exhibited good quality of vision, with minimally bothersome visual disturbances or photic phenomena.

Using Lean Six Sigma techniques to improve efficiency in outpatient ophthalmology clinics.

BACKGROUND: Increasing patient numbers, complexity of patient management, and healthcare resource limitations have resulted in prolonged patient wait times, decreased quality of service, and decreased patient satisfaction in many outpatient services worldwide. This study investigated the impact of Lean Six Sigma, a service improvement methodology originally from manufacturing, in reducing patient wait times and increasing service capacity in a publicly-funded, tertiary referral outpatient ophthalmology clinic. METHODS: This quality improvement study compared results from two five-months audits of operational data pre- and post-implementation of Lean Six Sigma. A baseline audit was conducted to determine duration and variability of patient in-clinic time and number of patients seen per clinic session. Staff interviews and a time-in-motion study were conducted to identify issues reducing clinic service efficiency. Solutions were developed to address these root causes including: clinic schedule amendments, creation of dedicated postoperative clinics, and clear documentation templates. A post-implementation audit was conducted, and the results compared with baseline audit data. Significant differences in patient in-clinic time pre- and post-solution implementation were assessed using Mann-Whitney test. Differences in variability of patient in-clinic times were assessed using Brown-Forsythe test. Differences in numbers of patients seen per clinic session were assessed using Student's t-test. RESULTS: During the baseline audit period, 19.4 patients were seen per 240-minute clinic session. Median patient in-clinic time was 131 minutes with an interquartile range of 133 minutes (84-217 minutes, quartile 1- quartile 3). Targeted low/negligible cost solutions were implemented to reduce in-clinic times. During the post-implementation audit period, the number of patients seen per session increased 9% to 21.1 (p = 0.016). There was significant reduction in duration (p < 0.001) and variability (p < 0.001) of patient in-clinic time (median 107 minutes, interquartile range 91 minutes [71-162 minutes]). CONCLUSIONS: Lean Six Sigma techniques may be used to reduce duration and variability of patient in-clinic time and increase service capacity in outpatient ophthalmology clinics without additional resource input.

Clinical Evaluation of a Novel Preloaded Intraocular Lens Delivery System During Routine Cataract Surgery.

PURPOSE: To evaluate the clinical handleability and acceptability of a novel preloaded intraocular lens (IOL) delivery system for implantation of the TECNIS ZCB00 IOL (Johnson & Johnson Surgical Vision, Inc., Santa Ana, CA, USA) during routine small-incision cataract surgery. SUBJECTS AND METHODS: In this prospective, open-label, noncomparative, unilateral or bilateral, multicenter study, adult subjects with unilateral or bilateral cataracts scheduled for IOL implantation were enrolled. Surgeons and surgical technicians completed per-eye day-of-surgery and end-of-surgical-day questionnaires. The primary endpoint of the study was the rate of acceptable overall clinical performance of the preloaded IOL delivery system. Other endpoints included additional responses from the questionnaires, preimplantation incision size, and safety. RESULTS: The study included 91 eyes that underwent cataract surgery and IOL implantation using the preloaded delivery system and were available for the 1-day postoperative visit. Five surgeons and 14 surgical technicians from four investigational sites participated in the study. The rate of acceptable overall clinical performance was 100% (91/91) of eyes, with most responses (78/91; 85.7%) being the highest possible rating of 5 (very satisfied). Favorable responses by most surgeons and surgical technicians regarding additional endpoints further highlighted the handleability and acceptability of the preloaded delivery system. No ocular adverse events or lens findings (ie, no cases of IOL instability, haptic breakage, IOL marking, or crimping) were reported. CONCLUSION: The results of this study demonstrated that this preloaded IOL delivery system was safe and effective during routine small-incision cataract surgery. TRIAL REGISTRATION: German Clinical Trials Register identifier, DRKS00014757.

Total keratometry in intraocular lens power calculations in eyes with previous laser refractive surgery.

IMPORTANCE: Intraocular lens (IOL) calculations in post-refractive cases remain a concern. Our study identifies improved options for surgeons. BACKGROUND: To evaluate and compare the prediction accuracy of IOL power calculation methods after previous laser refractive surgery using standard keratometry (SK), measured posterior corneal astigmatism (PCA) and total keratometry (TK). DESIGN: Retrospective consecutive cohort. PARTICIPANTS: A total of 50 consecutive patients (72 eyes) at a private institution who underwent cataract surgery with prior laser refractive procedures. METHODS: Methods using SK included ASCRS mean, Barrett True-K no history, Haigis-L and Shammas IOL formulae. Barrett True-K using posterior values (True K TK), Haigis and Holladay 1 Double-K methods using TK were also assessed. Post-surgery refraction was undertaken at minimum 3 weeks following surgery. MAIN OUTCOME MEASURES: Arithmetic and absolute IOL refractive prediction errors, variances in mean arithmetic IOL prediction error, and percentage of eyes within ±0.25D, ±0.50D, ±0.75D and ±1.00D of refractive prediction errors were compared. RESULTS: The Barrett True-K (TK) provided the lowest mean refractive prediction error (RPE) and variance for both prior myopes and hyperopes undergoing cataract surgery. The Barrett True-K (TK) exhibited the highest percentages of eyes within ±0.50D, ±0.75D and ±1.00D of the RPE compared to other formulae for prior myopic patients. CONCLUSIONS AND RELEVANCE: Accuracy of IOL power calculations in post-laser eyes can be improved by the addition of posterior corneal values as measured by the IOLMaster 700. The use of total keratometry may supplement outcomes when no prior refraction history is known.

Metastasis to the extraocular muscles: a case report, literature review and pooled data analysis.

Metastasis to the extraocular muscles (EOM) is rare. The existing literature comprises only of isolated case reports therefore a summative description of these lesions is lacking. This study presents a case of bilateral rectus muscle metastasis from malignant melanoma. Furthermore a literature review and pooled data analysis is undertaken with 43 articles encompassing 77 patients and 101 eyes. Mean age was 53 years, 54% were male, 66% had unilateral involvement and 34% had bilateral involvement. The primary malignancies were melanoma (n = 17, 22%), breast (n = 15, 15%) and carcinoid (n = 11, 14%). A single muscle was involved in 56 eyes (67%) and multiple muscles in 27 eyes (33%). Lateral rectus was most commonly affected (n = 44, 53%). Presenting symptoms included restricted eye movements (n = 48, 62%), proptosis (n = 45, 58%), diplopia (n = 27, 35%) and pain (n = 18, 23%). Scattered case reports have previously made it difficult to characterise this phenomenon thus a pooled data analysis is presented.

Comparison of Hill-radial basis function, Barrett Universal and current third generation formulas for the calculation of intraocular lens power during cataract surgery.

IMPORTANCE: This study represents a novel comparison of recently introduced intraocular lens power calculation formulas. BACKGROUND: To compare current new generation formulas for calculating the intraocular lens power for a standard cohort of patients undergoing cataract and lens replacement surgery in a private group practice in Australia. DESIGN: Retrospective case series comparison. PARTICIPANTS: Postoperative results from 400 consecutive patients undergoing implantation of an SN60WF intraocular lens post cataract removal by 12 surgeons were used. METHODS: Refractive outcomes were compared with expected targets to determine the predicted refractive outcomes using the Hill-radial basis function, Barrett Universal II and readily available third or fourth generation intraocular lens power calculation formulas. MAIN OUTCOME MEASURE: Mean absolute predicted error. RESULTS: The mean absolute predicted difference ranged from 0.30 to 0.34 D. There was no overall significant difference in the predicted difference or variance between formulas. All formulas achieved greater than 78.3% of eyes within ±0.5 D of intended refraction. The Hill-radial basis function and Barrett formulas provided the lowest mean numerical error compared with existing formulas in short and long eyes, respectively. The Barrett Universal II formula had the lowest percentage of refractive surprises (>1 D from predicted error) across all axial lengths. CONCLUSIONS AND RELEVANCE: Acceptable outcomes can be achieved with optical biometry, consistent surgical technique and use of current intraocular lens power calculation formulas. The Barrett Universal II formula may provide the lowest risk of refractive surprise compared with other intraocular lens power calculation formulas.

Visual and refractive outcomes following implantation of a new trifocal intraocular lens.

BACKGROUND: Independence from all optical aids, and freedom from unwanted symptoms, following cataract and lens surgery remains the ultimate goal of both patient and surgeon. The development of trifocal IOL technology provides an ever-increasing range of options. The purpose of our study is to understand the predictability, safety and efficacy of a new trifocal intraocular lens (IOL) following cataract or refractive lens exchange (RLE) surgery. METHODS: This was a retrospective consecutive case series of patients undergoing cataract extraction or RLE followed by implantation of the Alcon IQ Panoptix IOL. Pre and postoperative refractive and visual parameters were recorded and evaluated. As the cohort followed a normal distribution, standard parametric tests were used. Paired t-test was used to compare the difference between target and postoperative refractive errors. The incidence of intraoperative and postoperative complications was also reported. RESULTS: The IOL was implanted in 66 eyes of 33 patients. Mean postoperative spherical equivalent (SE) refraction was -0.08 ± 0.25 dioptres (D). This was not significantly different from the target refraction (p = 0.841). Sixty-five percent of patients were within ± 0.25 D of the target SE refraction with 100% within ± 0.50 D of intended correction. Mean postoperative uncorrected distance visual acuity (UDVA) was 0.01 ± 0.10 LogMAR. All patients achieved an unaided distance acuity of 20/40 or better postoperatively. Binocularly, 100% saw 0.20 LogMAR or better at near without correction and 88.9% achieved this level for uncorrected intermediate visual acuity. No intraoperative complications were noted. Five patients complained of moderate haloes in the early postoperative period. CONCLUSION: The AcrySof IQ Panoptix IOL provides functional uncorrected visual acuity at distance, intermediate and near positions. Our results remain equivalent with existing trifocal IOL outcomes and provide surgeons with a further IOL alternative for the patient motivated to obtain true spectacle independence. Surgeons should consider individual reading and working requirements when counselling patients preoperatively to optimise postoperative patient satisfaction.

Efficacy and Tolerability of Travoprost 0.004%/Timolol 0.5% Fixed-Dose Combination for the Treatment of Primary Open-Angle Glaucoma or Ocular Hypertension Inadequately Controlled with Beta-Blocker Monotherapy.

Objective. To evaluate the efficacy and tolerability of travoprost 0.004%/timolol 0.5% fixed-dose combination (TTFC) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) inadequately controlled on beta-blocker monotherapy. Methods. In this phase IV, open-label study, 156 patients on beta-blocker monotherapy with mean intraocular pressure (IOP) between 18 and 32 mmHg were randomized (no washout period) to receive TTFC for 8 weeks (TTFC group) or to continue beta-blocker monotherapy for 4 weeks followed by TTFC for the remaining 4 weeks (beta-blocker group). Results. The mean IOP (±standard deviation) at baseline in the TTFC and beta-blocker groups was 22.5 ± 2.5 mmHg and 22.2 ± 2.3 mmHg, respectively, and at weeks 4 and 8, was 16.7 ± 3.1 mmHg and 16.1 ± 3.1 mmHg, respectively, in TTFC group and 21.1 ± 3.1 mmHg and 16.1 ± 2.8 mmHg, respectively, in the beta-blocker group. There was a significant least squares mean difference between TTFC and beta-blocker in 8 a.m. IOP at week 4 (-4.6 mmHg; one-sided 95% confidence interval [-inf, -3.9]; p < 0.0001 [primary endpoint]); the upper bound of the 95% confidence interval was within the prespecified limit (<0). Both treatments were well tolerated. Conclusion. Superior IOP control was achieved with TTFC in patients with OAG or OHT previously uncontrolled with beta-blockers. No new safety findings were identified. This trial is registered with ClinicalTrials.gov NCT02003391.

Update and clinical utility of the LenSx femtosecond laser in cataract surgery.

The introduction of femtosecond lasers to cataract surgery has been the major disruptive technology introduced into ophthalmic surgery in the last decade. Femtosecond laser cataract surgery (FLACS) integrates high-resolution anterior segment imaging with a femtosecond laser allowing key steps of cataract surgery to be performed with computer-guided laser accuracy, precision, and reproducibility. Since the introduction of FLACS, there have been significant advances in laser software and hardware as well as surgeon experience, with over 250 articles published in the peer-reviewed literature. This review examines the published evidence relating to the LenSx platform and discusses surgical techniques, indications, safety, and clinical results.

Assessment of corneal curvature using verion optical imaging system: a comparative study.

BACKGROUND: Keratometry is a critical determinant of the postoperative refractive outcome. This study evaluates the comparability of keratometry measurements obtained using the Verion Optical Imaging System with devices used in current clinical practice. Further, it determines the interobserver reliability of the Verion Optical Imaging System. DESIGN: Retrospective analysis of patient data PARTICIPANTS: Keratometric data was obtained from 100 patients presenting for pre-operative evaluation. Furthermore, repeatability and reproducibility were assessed using 15 healthy volunteers. METHODS: Corneal curvature values acquired by the Verion Optical Imaging System were compared with existing keratometry devices including autokeratometry, partial coherence interferometry (IOLMaster) and Scheimpflug corneal topography (Pentacam). MAIN OUTCOME MEASURES: Direct comparison of corneal power, cylinder, axis of astigmatism and vector analysis were performed using correlation and Bland-Altman analyses. Reproducibility and reliability of the device were assessed using within-subject standard deviation and intraclass correlation coefficients for experienced and inexperienced technicians. RESULTS: There was no statistically significant difference between Verion values and those obtained by other methods in relation to mean keratometry, corneal astigmatism, steep meridian and vector analyses (P > 0.05). Bland-Altman plots showed narrow limits of agreement for keratometry and astigmatism and wider agreement for steep meridian. Intraoperator reliability for both experienced and inexperienced operators and interoperator reproducibility showed no statistically significant differences between values. CONCLUSION: Measurements show no significant difference from those obtained by the other devices. This suggests the Verion system is en par with instruments used in current clinical practice. The Verion Optical Imaging System produces repeatable data with no difference related to operator experience.