Impact of Aspheric Monofocal Intraocular Lens Implantation on Uncorrected Intermediate Visual Acuity: a Combined Analysis.

Purpose: To evaluate binocular intermediate visual acuity (IVA), depth of focus, and other visual outcomes achieved with a monofocal aspheric intraocular lens (IOL) using pooled data from 2 randomized, double-masked, controlled trials. Patients and Methods: The studies conducted at 32 sites included patients aged ≥22 years with bilateral cataracts, preoperative corneal astigmatism 1.0 D, and lens power 18.0-25.0 D. Patients received bilateral AcrySof IQ IOLs (SN60WF). Primary endpoint data were collected at month 6. Binocular uncorrected and corrected distance visual acuity (UDVA and CDVA) at 4 m, binocular uncorrected and corrected IVA (UIVA and DCIVA) at 66 cm, manifest refraction spherical equivalent (MRSE), and binocular defocus curve at 4 m were assessed under photopic conditions. Validated questionnaires were used to assess spectacle use and quality of vision. Results: Of 233 patients who received SN60WF, 228 had visual acuity data at 6 months. Under photopic conditions, 51% of the eyes had pupils >4 mm, 40% had pupils 3-4 mm, and 9% had pupils <3 mm. Mean ± SD UDVA and CDVA were -0.019 ± 0.110 and -0.088 ± 0.082 logMAR, respectively. Mean ± SD UIVA and DCIVA were 0.125 ± 0.145 and 0.196 ± 0.139 logMAR, respectively. UIVA and DCIVA of 20/32 or better were achieved by 83% (188/228) and 71% (162/228) of patients, respectively. Mean ± SD MRSE was -0.007 ± 0.404 D for the first eye and 0.036 ± 0.371 for the second eye. The defocus curve demonstrated binocular vision of 0.24 logMAR or better from +1.2 to -1.5 D. Spectacle independence for distance and intermediate vision was reported by 86% and 41% of the patients, respectively. Based on questionnaires, 61%, 79%, and 65% of the patients did not experience starbursts, halos, or glare. Conclusion: A monofocal aspheric IOL (SN60WF) assessed in a large, pooled study provided excellent distance vision and clinically functional intermediate vision.

Tolerance to refractive error with a new extended depth of focus intraocular lens.

PURPOSE: To evaluate the tolerance to refractive errors of a new purely refractive extended depth of focus (EDF) intraocular lens (IOL) using preclinical and clinical metrics. METHODS: Preclinical evaluation included computer simulations of visual acuity (sVA) and dysphotopsia profile of different IOL designs (refractive EDF, diffractive EDF, multifocal, standard, and enhanced monofocals) using an appropriate eye model with and without ±0.50 D defocus and/or +0.75 D of astigmatism. Patients bilaterally implanted with a refractive EDF (Model ZEN00V) or an enhanced monofocal (Model ICB00) IOL from a prospective, randomized study were included. At the 6-month postoperative visit, uncorrected and corrected distance vision (UDVA and CDVA), visual symptoms, satisfaction and dependency on glasses were evaluated in a subgroup of patients with absolute residual refractive error of >0.25 D in one or both eyes. RESULTS: In the presence of defocus and astigmatism, sVA was comparable for all except the multifocal IOL design. The refractive EDF was more tolerant to myopic outcomes and maintained a monofocal-like dysphotopsia profile with defocus. Binocular logMAR UDVA was -0.03 ± 0.08 for ZEN00V and -0.02 ± 0.11 for ICB00. 100% ZEN00V and 97% ICB00 patients did not need glasses and were satisfied with their distance vision. Monocular CDVA, contrast sensitivity and visual symptoms were also similar between both groups. CONCLUSIONS: The clinical outcomes of the refractive EDF IOL demonstrated high quality distance vision and dysphotopsia comparable to a monofocal IOL, even in the presence of refractive error, thus matching the design expectations of the EDF IOL.

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.

Extended Depth-of-Focus Intraocular Lens Implantation in Patients with Age-Related Macular Degeneration: A Pilot Study.

Purpose: To assess visual outcomes of the implantation of a non-diffractive extended depth of focus (EDOF) intraocular lens (IOL) in patients with age-related macular degeneration (AMD). Setting: Ophthalmology practice, Sydney, Australia. Design: Retrospective chart review. Methods: Patients with AMD undergoing cataract surgery and receiving non-diffractive EDOF AcrySof IQ Vivity IOL implantation over a 2-year period were identified. Corrected distance visual acuity (CDVA), distance-corrected near visual acuity (DCNVA; 50 cm), contrast sensitivity, central foveal thickness, VF-14 questionnaire results, and quality of life where available were analyzed. Results: A total of 28 sequential patients (51 eyes) were included in this pilot study (46% male, mean age 77.4 years). Of 27 eyes that had late AMD, 17 (63%) had wet AMD. Mean patient preoperative CDVA was logMAR 0.32±0.29. Postoperative monocular CDVA and DCNVA were logMAR 0.20±0.25 and N9±5 (range N5-N36), respectively. Eyes achieving postoperative CDVA of Snellen 6/5-6/12 (n=42, 82%), 6/15-6/24 (n=7, 14%), and greater than 6/24 (n=2, 4%) achieved a mean DCNVA of N8 (range N5-N10), N13 (range N10-N18), and N27 (range N18-N36), respectively. Eyes achieving CDVA of Snellen 6/5-6/12 showed contrast sensitivity within the normal range. On postoperative VF-14 questionnaire, patients with CDVA of Snellen 6/5-6/12 reported minimal visual impairment, while patients with CDVA greater than 6/15 reported mild impairment. A majority of patients (96%, n=27) were satisfied with the improvement in quality of life postoperatively. No intraoperative complications were reported. Conclusion: The EDOF AcrySof IQ Vivity IOL provides improved near vision proportional to distance vision in patients with early AMD.

International Multicenter, Myopic and Myopic Astigmatism Femto LASIK, Customized by Automated Ray-Tracing Ablation Profile Calculation: A Postmarket Study.

Purpose: To assess the safety and efficacy of a customized ablation treatment (InnovEyes) to correct myopia and myopic astigmatism with femtosecond laser-assisted in situ keratomileusis (Femto LASIK). Patients and Methods: In this prospective, nonrandomized, multicenter study, 113 patients (225 eyes) with preoperative myopia less than -9.0 diopters (D) and astigmatism 0 to -4.0 D (based on InnovEyes refraction) underwent wavefront, tomography, and biometry assessment using a single diagnostic device (InnovEyes sightmap). These data were imported and used unmodified by the InnovEyes algorithm to automatically calculate and optimize correction of lower- and higher­order aberrations (HOAs) treated by the EX500 ablation profile. Visual acuity, refractive error, HOAs, and patient satisfaction were evaluated over 3 months. Results: A total of 106 patients (212 eyes) completed the study and were included in the analysis. Mean preoperative manifest refraction spherical equivalent (MRSE) was -3.38±1.76 D. At Month 3, uncorrected distance visual acuity was 20/20 or better in 208/212 (98.1%) eyes, and it was the same as, or better than, the preoperative best-corrected distance visual acuity (CDVA) in 162/212 (76.4%) eyes; 76/212 (35.8%) eyes gained ≥1 line of CDVA. MRSE was within ±0.5 D in 195/212 (92.0%) eyes. Additionally, 201/209 (96.2%) eyes had no change (defined as a change between -0.1 µm and 0.1 µm, inclusive) in HOAs, and 105/106 (99.1%) patients reported to be satisfied with the results. Conclusion: Customizing ray-tracing Femto LASIK with this platform appeared safe and effective in correcting myopic astigmatism and also achieved a significant percentage of eyes gaining lines of vision, potentially by addressing HOAs, along with a consistently high level of patient satisfaction.

The Novel Optical Design and Clinical Classification of a Wavefront-Shaping Presbyopia-Correcting Intraocular Lens.

Purpose: To evaluate the clinical rationale of wavefront-shaping technology, describe how intraocular lenses (IOLs) using wavefront-shaping technology are differentiated from refractive or diffractive optical presbyopia-correcting designs, and describe the mode of action of this technology. Methods: Extended depth of focus (EDoF) IOLs are the latest class of presbyopia-correcting IOLs addressing the growing demand of patients for reduced spectacle dependence. These use various optical technologies, including diffractive designs (eg, TECNIS Symfony ZXR00 and AT LARA 29 MP) and non-diffractive designs such as small aperture (eg, IC-8 IOL and XtraFocus Pinhole Implant), spherical aberration (eg, MINI WELL Ready and LuxSmart), and wavefront shaping (eg, AcrySof IQ Vivity DFT015 and Clareon Vivity CNWET0). Despite some improvement in visual acuity at intermediate and near distances, these technologies can still be associated with increased rate of visual disturbances or poorer distance vision compared with monofocal IOLs. One way to overcome such limitations is using a wavefront-shaping optical principle. Results: Clinical data show that wavefront-shaping technology results in a continuous EDoF compared with a monofocal IOL while exhibiting a minimal halo, similar to an aspheric monofocal IOL. Clinically, this translates to a lens that has proven to exceed the American National Standards Institute/American Academy of Ophthalmology criteria for an EDoF IOL. Conclusion: The novel wavefront-shaping optic technology allows patients to achieve a continuous range of vision from distance to functional near with low levels of visual disturbances comparable with aspheric monofocal IOLs.

Ray-tracing-guided myopic LASIK: real-world clinical outcomes.

PURPOSE: To assess effectiveness of individualized ray-trace based laser in situ keratomileusis (LASIK) for correction of myopia in everyday clinical practice. SETTING: Single-site private practice. DESIGN: Retrospective nonrandomised unmasked chart review. METHODS: Consecutive, myopic eyes (range ≤-8.25 diopters [D] sphere; astigmatism 0 to -4.25 D) treated with ray-trace based LASIK were included. Patients underwent wavefront, tomography, and biometry assessment using the InnovEyes Sightmap diagnostic device. The ray-trace based algorithm (InnovEyes algorithm) then generated an individualized 3D eye model and calculated a customized LASIK ablation profile. Postoperative visual acuity, refractive error and whole eye higher-order aberrations (HOAs) were evaluated over 3 months. RESULTS: The procedure was performed on 400 eyes (200 patients). Mean preoperative manifest refraction spherical equivalent was -3.39 ± 1.58 D (right eye -3.84 ± 1.63 D, left eye -3.98 ± 1.75 D). At month 3, uncorrected distance visual acuity (UDVA) was ≥20/20 in all eyes, ≥20/16 in 89% (right eye 90%, left eye 89%), ≥20/12 in 51% (54% right eye; 47% left eye), and 20/10 in 8% (right eye 8%; left eye 9%) of eyes respectively. UDVA was within 1 line of preoperative corrected distance visual acuity in 98% of eyes (right eye 98.5%; left eye 98%) and 39% of eyes (right eye 38%; left eye 39%) gained 1 line improvement. There was a statistically but not clinically significant increase in total HOAs (right eye 0.06 ± 0.133 µm; left eye 0.057 ± 0.125 µm; P < .001). The spherical aberration decreased (right eye -0.047 ± 0.095 µm, P < .001; left eye -0.051 ± 0.091 µm, P < .001). CONCLUSIONS: Ray-trace based LASIK was safe and effective for correction of myopia with and without astigmatism. Approximately, half the eyes achieved ≥20/12.5 UDVA and 8% achieved 20/10. There was no clinically significant increase in total whole eye HOAs.

Cost-benefit analysis of a trifocal intraocular lens versus a monofocal intraocular lens from the patient's perspective in the United States.

PURPOSE: To conduct a cost-benefit analysis of AcrySof IQ PanOptix trifocal intraocular lens (TFNT00 IOL) versus AcrySof monofocal IOL (SN60AT) from the patient perspective in the United States (US). METHODS: A de novo Markov model was developed to estimate the mean total lifetime patient costs and vision-related quality of life (measured as quality adjusted life-years (QALYs)) with each intervention (TFNT00 and SN60AT) and the incremental differences between these two treatments. The resulting incremental quality of life gain was mapped to the US patient willingness to pay threshold of $50,000 per QALY gain to estimate the lifetime net monetary value, measured as the net monetary benefit of TFNT00 IOL. Model inputs (transition probabilities, costs, discount rate, utilities, and event rates) were derived from the FDA IDE study (NCT03280108), published literature, clinical experience, and other relevant sources. RESULTS: Bilateral cataract surgery with implantation of the advanced technology IOL (AT-IOL) TFNT00 provides improved vision-related quality of life (QALY gain of 0.67) at an incremental lifetime cost of $2,783 compared to monofocal IOL. This incremental QALY gain translated into a lifetime net monetary benefit of $30,941 at the patient willingness to pay threshold of $50,000/QALY gain. Results were most sensitive to disutility due to wearing glasses, patient out of pocket costs for bilateral AT-IOL procedure, and post-operative spectacle dependence rates. CONCLUSIONS: AcrySof IQ PanOptix IOL provides greater improvement in vision related quality of life compared to no presbyopia correction with a monofocal IOL. This study shows PanOptix is a cost-beneficial treatment strategy for patients willing to pay out of pocket for cataract surgery.

A Cost-Effectiveness Analysis of AcrySof IQ Vivity Intraocular Lens (IOL) from Private Health Fund Perspective in Australia.

Purpose: AcrySof IQ Vivity is a unique non-diffractive extended depth of focus intraocular lens with wavefront-shaping X-WAVE technology. This study evaluated the cost-effectiveness of AcrySof IQ Vivity intraocular lens (DFT015) compared with standard aspheric monofocal intraocular lens (SN60WF), from a private health fund perspective in Australia. Methods: A Markov model was developed using the following health states: well, need for spectacles (near/distance/bifocal/varifocal), very bothersome visual disturbances (glare/haloes/starbursts) - with/without spectacles, and death. Model inputs were sourced from a randomized clinical study (NCT03010254), published literature, prostheses list and clinical opinion. A lifetime horizon (up to 30 years) was considered, and cost and health outcomes were discounted at 5% per annum. Model outcomes included incremental cost-effectiveness ratio defined as incremental cost per quality adjusted life year gain. Sensitivity and scenario analyses were also conducted. Results: Bilateral implantation of DFT015 intraocular lens provided quality adjusted life year gain of 0.16 at an incremental cost of AU$307 compared to bilateral SN60WF, leading to an incremental cost-effectiveness ratio of AU$1908/quality adjusted life year, well below the cost-effectiveness threshold (Range: AU$45,000-AU$75,000) typically used by Medical Services Advisory Committee in Australia. Results were most sensitive to intraocular lens costs, post-operative spectacle dependence, and disutility due to wearing glasses. Robustness of the results was further confirmed by probabilistic sensitivity analysis and scenario analyses. Conclusion: AcrySof IQ Vivity intraocular lens is a highly cost-effective treatment strategy with improved vision-related quality of life outcomes for presbyopic cataract surgery patients.

Pterygium and Ocular Surface Squamous Neoplasia: Optical Biopsy Using a Novel Autofluorescence Multispectral Imaging Technique.

In this study, differentiation of pterygium vs. ocular surface squamous neoplasia based on multispectral autofluorescence imaging technique was investigated. Fifty (N = 50) patients with histopathological diagnosis of pterygium (PTG) and/or ocular surface squamous neoplasia (OSSN) were recruited. Fixed unstained biopsy specimens were imaged by multispectral microscopy. Tissue autofluorescence images were obtained with a custom-built fluorescent microscope with 59 spectral channels, each with specific excitation and emission wavelength ranges, suitable for the most abundant tissue fluorophores such as elastin, flavins, porphyrin, and lipofuscin. Images were analyzed using a new classification framework called fused-classification, designed to minimize interpatient variability, as an established support vector machine learning method. Normal, PTG, and OSSN regions were automatically detected and delineated, with accuracy evaluated against expert assessment by a specialist in OSSN pathology. Signals from spectral channels yielding signals from elastin, flavins, porphyrin, and lipofuscin were significantly different between regions classified as normal, PTG, and OSSN (p < 0.01). Differential diagnosis of PTG/OSSN and normal tissue had accuracy, sensitivity, and specificity of 88 ± 6%, 84 ± 10% and 91 ± 6%, respectively. Our automated diagnostic method generated maps of the reasonably well circumscribed normal/PTG and OSSN interface. PTG and OSSN margins identified by our automated analysis were in close agreement with the margins found in the H&E sections. Such a map can be rapidly generated on a real time basis and potentially used for intraoperative assessment.

Multicountry clinical outcomes of a new nondiffractive presbyopia-correcting IOL.

PURPOSE: To evaluate the effectiveness and safety of a new presbyopia-correcting intraocular lens (IOL) with a nondiffractive design, DFT015, compared with an aspheric monofocal IOL, SN60WF. SETTING: 19 investigational sites in 4 countries: Australia, Canada, Spain, and the United Kingdom. DESIGN: Prospective, randomized, parallel-group, controlled, assessor- and patient-masked clinical study. METHODS: Participants aged ≥22 years with bilateral cataracts were randomized to DFT015 or SN60WF in a 5:4 ratio and masked until final postoperative follow-up at month 6. The primary effectiveness objective was superiority of DFT015 over SN60WF in mean monocular photopic distance-corrected intermediate visual acuity (DCIVA) at month 3. Secondary effectiveness objectives included noninferiority of DFT015 to SN60WF in mean monocular photopic corrected distance visual acuity (CDVA) and superiority in the mean monocular photopic distance-corrected near visual acuity (DCNVA) at month 3. Visual disturbances were assessed at month 6. RESULTS: 282 patients were randomized to DFT015 (n = 159) or SN60WF (n = 123). All effectiveness objectives were achieved at month 3 in first eyes. For monocular photopic results in first eyes, DFT015 demonstrated superior mean DCIVA (least squares means of -0.139 logMAR in favor of DFT015, P < .001), noninferior mean CDVA (97.5% upper confidence limit [UCL] of the difference was <0.1 logMAR) and superior mean DCNVA (95% UCL of the difference was <0.0 logMAR) compared with SN60WF at month 6. DFT015 exhibited a similar visual disturbance profile to that of SN60WF. CONCLUSIONS: DFT015 provided superior intermediate and near vision and a similar visual disturbance profile compared with an aspheric monofocal IOL.

New methodology for measuring intraocular lens performance using acuity reserve.

PURPOSE: To validate a new methodology of intraocular lens (IOL) assessment using acuity reserve analysis via area under the curve (AUC) to assess intermediate vision. SETTING: Study 1 was conducted at 17 sites in Australia, Chile, and Europe. Study 2 was conducted at 15 sites in Australia, Brazil, and Europe. DESIGN: Post hoc analyses of defocus curve results from 2 clinical trials (study 1: single-arm investigation of the AcrySof IQ PanOptix Trifocal IOL [model TFNT00; Alcon Research LLC]; study 2: comparative investigation of AcrySof PanOptix Trifocal IOL vs the AT LISA Trifocal IOL [model 839MP; Carl Zeiss Meditec AG]). METHODS: Acuity reserve was calculated using AUC compared with visual demand (logMAR) at various distances. Study 1 validated the model; study 2 compared acuity reserve, for a range of defocus levels, for the 2 IOLs. RESULTS: The defocus curve (study 1 [149 patients; 298 eyes]) showed good visual acuity (ie, >20/25) at all defocus levels; the AUC estimate showed 2 lines or more of reserve at -2.50 diopters. Comparative post hoc analysis (study 2 [182 patients]) demonstrated significantly improved acuity reserve with PanOptix IOL vs AT LISA IOL at 20 to 40 days postoperatively (P < .001) and 120 to 180 days postoperatively (P < .001). CONCLUSIONS: Acuity reserve analysis using AUC represents a new methodology for comparative IOL assessment, providing additional detail beyond defocus curve analysis. This method demonstrated that the PanOptix Trifocal IOL was superior to the AT LISA Trifocal IOL (model 839MP) for visual acuity at near to intermediate distances with visual acuity reserve analysis.

Patient and Economic Burden of Presbyopia: A Systematic Literature Review.

PURPOSE: The objective of this systematic literature review (SLR) was to collate, report, and critique published evidence related to epidemiology and patient and economic burden of presbyopia. PATIENTS AND METHODS: A systematic literature search was conducted in MEDLINE®, Embase®, and Cochrane Library databases from the time of inception through October 2018 using Cochrane methodology. Studies published in English language reporting on epidemiology and patient and economic burden of presbyopia were included. RESULTS: Initial systematic literature search yielded 2,228 citations, of which 55 met the inclusion criteria (epidemiology, 44; patient burden, 14; economic burden, 1) and were included in this review. Globally, 1.09 billion people are estimated to be affected by presbyopia. The reported presbyopia prevalence varied across regions and by age groups, with the highest prevalence of 90% reported in the Latin America region in adults ≥35 years. Presbyopic patients report up to 22% decrease in quality-of-life (QoL) score, and up to 80% patients with uncorrected presbyopia report difficulty in performing near-vision related tasks. About 12% of presbyopes required help in performing routine activities, and these visual limitations reportedly induce distress and low self-esteem in presbyopia patients. Uncorrected presbyopia led to a 2-fold increased difficulty in near-vision-related tasks and a >8-fold increased difficulty in very demanding near-vision-related tasks. Further, uncorrected presbyopia leads to a decrement in patients' QoL, evident by the low utility values reported in the literature. Annual global productivity losses due to uncorrected and under-corrected presbyopia in working-age population (<50 years) were estimated at US$ 11 billion (0.016% of the global domestic product (GDP) in 2011, which increased to US$ 25.4 billion if all people aged <65 years were assumed to be productive. CONCLUSION: Uncorrected presbyopia affects patients' vision-related quality of life due to difficulty in performing near-vision-related tasks. In addition, un-/under-corrected presbyopia could lead to productivity losses in working-age adults.

DNA methylation and gene expression pattern of ACE2 and TMPRSS2 genes in saliva samples of patients with SARS-CoV-2 infection

COVID-19 caused by SARS-CoV-2 became a pandemic affecting the health and economy of the world. Although it was known that this virus uses ACE2 protein along with TMPRSS2 to enter the host cell, the methylation pattern and gene expression of ACE2 and TMPRSS2 genes are not explored in saliva samples of patients infected with COVID-19. The study aimed to quantify promoter methylation of ACE2 and TMPRSS2 along with its mRNA expression in saliva samples of COVID-19 patients in order to understand the regulatory mechanism of these genes in SARS-CoV-2 infection. Saliva samples were collected from thirty male patients with SARS-CoV-2 infection and thirty age-matched healthy control male subjects. Q MS PCR and qRT PCR was performed to quantify the promoter DNA methylation and mRNA expression of ACE2 and TMPRSS2 respectively. Our study didnt find any significant difference between methylation and expression of these two genes in cases compared to control subjects. However there was significant positive correlation between DNA methylation of ACE2 and its gene expression. Among cases, the sample collected [≥]7 days after appearance of symptoms showed higher amount of methylation in both ACE2 and TMPRSS2 genes when compared to sample collected before 7 days. In conclusion, we found that ACE2 and TMPRSS2 methylation plays a role in COVID-19.

Multicenter visual outcomes comparison of 2 trifocal presbyopia-correcting IOLs: 6-month postoperative results.

PURPOSE: To clinically evaluate visual performance of the AcrySof IQ PanOptix TFNT00 and AT LISA tri 839MP intraocular lenses (IOLs) in binocular visual acuity (VA) and to characterize low-contrast visual performance at 6 months postimplantation. SETTING: Multicenter, 15 sites. DESIGN: Prospective, parallel-group, randomized, double-masked, postmarketing clinical study. METHODS: Binocular uncorrected distance (UDVA, 4 m), intermediate (UIVA, 60 cm), and near (UNVA, 40 cm) visual acuities and binocular defocus curves were evaluated under photopic lighting conditions. Photopic and mesopic contrast sensitivities with and without glare were assessed. RESULTS: The study included 182 subjects (62% women; mean age, 66 ± 9.4 years) who were implanted bilaterally with the TFNT00 IOL (n = 93) or 839MP IOL (n = 89), and binocular VA was evaluated 4 to 6 months (120-180 days) postimplantation. The TFNT00 IOL group showed superior visual outcomes compared with the 839MP IOL group in binocular UIVA (P = .001) and UNVA (P = .003) and noninferior outcomes in UDVA (95% CI, -0.023 to 0.041; upper limit <0.1 logarithm of the minimum angle of resolution [logMAR] [margin of noninferiority]). Mean defocus curve from 0.00 to -3.00 diopter (D) ranged from 0.1 to 0.0 logMAR for both IOLs; better mean VA values (logMAR) were observed in the TFNT00 IOL group between -1.50 and -2.50 D compared with those of the 839MP IOL group. Contrast sensitivity values were similar between the 2 groups in all conditions. CONCLUSIONS: The results of this study showed improved visual performance at near and intermediate distances with the TFNT00 IOL compared with that of the 839MP IOL.

Pedicle Descemet membrane endothelial keratoplasty performed using a new corneal punch.

PURPOSE: To create a Descemet membrane endothelial keratoplasty (DMEK) graft with a pedicle that allows better control of orientation, centration, and unrolling of the DMEK scroll. SETTING: Macquarie University Hospital, Sydney, NSW, Australia. DESIGN: Prospective nonrandomized interventional case series. METHODS: Eleven eyes of 10 patients with corneal endothelial failure underwent the modified DMEK surgery. A new corneal punch with a 7.5 mm central zone and a 3.0 mm long pedicle was used to produce a graft with a tail. The pedicle was used to orient and drag the graft into the anterior chamber, and the tail was extravasated. The graft was unrolled and centered using the pedicle, and 24% SF6 gas was injected to applanate the graft. The pedicle was truncated. The graft manipulation time, defined as the time from graft insertion to gas injection, was measured. The patient and donor characteristics, postoperative corrected distance visual acuity (CDVA), and endothelial cell count (ECC) at 3 months were reported. RESULTS: Ten grafts attached with 1 requiring reinjection of gas. The CDVA improved to ≥6/9 in 9 eyes, and the remaining were limited by preexisting disease. The ECC loss for the first 5 grafts was 28% ± 5% with manipulation time of 12 ± 6 minutes. This improved to 18% ± 7% (P = .03) and 3 ± 2 minutes (P = .007) for the last 6 grafts. CONCLUSIONS: The new corneal punch generated a keyhole-shaped DMEK graft. After a period of learning, the manipulation time was decreased, improving ECC. The pedicle seemed to improve control over orientation, unrolling, centration, and rebubbling, potentially increasing the ease of DMEK surgery. The pedicle was safely truncated without sequelae.

Innovative trifocal (quadrifocal) presbyopia-correcting IOLs: 1-year outcomes from an international multicenter study.

PURPOSE: To evaluate visual acuity (VA) and safety of the new AcrySof IQ PanOptix presbyopia-correcting IOL at 12 months postimplantation. SETTING: Seventeen sites in Europe, Australia, and South America. DESIGN: Prospective, single-arm, nonmasked, nonrandomized study. METHODS: Of 167 patients enrolled, 149 received study IOLs in both eyes; 145 completed the study. Binocular uncorrected distance VA (UDVA; 4 m), monocular corrected distance VA (CDVA), binocular distance-corrected intermediate VA (DCIVA; 60 cm and 80 cm), binocular uncorrected near VA (UNVA; 40 cm), and binocular defocus curves were evaluated. Safety was assessed by monitoring adverse events (AEs). RESULTS: Of 149 patients, 92 patients (62%) were women and 139 patients (93%) were white; mean ± SD age was 68.9 ± 9.3 years. At 12 months, mean binocular UDVA was 0.02 ± 0.11 logarithm of the minimum angle of resolution (logMAR); monocular CDVA was 0.01 ± 0.13 logMAR (first eye) and 0.01 ± 0.10 logMAR (second eye); binocular DCIVA was 0.04 ± 0.12 logMAR and 0.08 ± 0.14 logMAR at 60 cm and 80 cm, respectively; and binocular UNVA was 0.07 ± 0.11 logMAR. At 6 months, mean binocular defocus curve VA (0.00 diopter [D] to -3.00 D) ranged from -0.04 to 0.13 logMAR. Binocular VA at distance (0.00 D), intermediate (-1.50 D), and near (-2.50 D) was -0.04 ± 0.11 logMAR, 0.07 ± 0.13 logMAR, and 0.07 ± 0.13 logMAR, respectively. Serious ocular AE rates were 1.4% or less in first and second eyes. Posterior capsulotomy rates were 3.4% (first eye) and 2.7% (second eye). CONCLUSIONS: The study IOL provided good VA outcomes. Defocus curve showed VA of 20/25 Snellen or better from near to intermediate distance. Rates of serious and nonserious AEs were low.

Novel automated non invasive detection of ocular surface squamous neoplasia using multispectral autofluorescence imaging.

PURPOSE: Diagnosing Ocular surface squamous neoplasia (OSSN) using newly designed multispectral imaging technique. METHODS: Eighteen patients with histopathological diagnosis of Ocular Surface Squamous Neoplasia (OSSN) were recruited. Their previously collected biopsy specimens of OSSN were reprocessed without staining to obtain auto fluorescence multispectral microscopy images. This technique involved a custom-built spectral imaging system with 38 spectral channels. Inter and intra-patient frameworks were deployed to automatically detect and delineate OSSN using machine learning methods. Different machine learning methods were evaluated, with K nearest neighbor and Support Vector Machine chosen as preferred classifiers for intra- and inter-patient frameworks, respectively. The performance of the technique was evaluated against a pathological assessment. RESULTS: Quantitative analysis of the spectral images provided a strong multispectral signature of a relative difference between neoplastic and normal tissue both within each patient (at p < 0.0005) and between patients (at p < 0.001). Our fully automated diagnostic method based on machine learning produces maps of the relatively well circumscribed neoplastic-non neoplastic interface. Such maps can be rapidly generated in quasi-real time and used for intraoperative assessment. Generally, OSSN could be detected using multispectral analysis in all patients investigated here. The cancer margins detected by multispectral analysis were in close and reasonable agreement with the margins observed in the H&E sections in intra- and inter-patient classification, respectively. CONCLUSIONS: This study shows the feasibility of using multispectral auto-fluorescence imaging to detect and find the boundary of human OSSN. Fully automated analysis of multispectral images based on machine learning methods provides a promising diagnostic tool for OSSN which can be translated to future clinical applications.