PURPOSE: The enVista ASPIRE™ Toric (ETA) and enVista ASPIRE™ (EA) intraocular lenses (IOLs) are designed for primary implantation in the capsular bag of adult patients to correct aphakia following cataract extraction, with the toric model addressing pre-existing astigmatism. These hydrophobic acrylic monofocal IOLs provide an extended depth of focus (DOF) compared with standard monofocal lenses. This study aims to evaluate their visual performance, including visual acuity at different distances, defocus curve, and the presence of dysphotopsia, to assess the functional benefits of this new platform of enhanced monofocal IOLs.

SETTING: This is a prospective, multicentre study of four surgeons from two study centres (Unidad de cirugía facorefractiva, Hospital Universitario Miguel Servet, Zaragoza, Spain, and Hospital Universitario Ramón y Cajal, Madrid, Spain) in patients presenting for cataract surgery.

METHODS: This study evaluates the visual performance of ETA and EA IOLs in patients with cataracts. Eligible patients had a normoreactive pupil and no prior ocular pathology or surgery. All procedures were femtosecond laser-assisted cataract surgeries (Victus, Bausch & Lomb, Inc) with APEX-centred implantation. Outcomes included refractive error best-corrected and uncorrected visual acuity at distance (BCDVA and UDVA) and intermediate (DCIVA and UIVA), and the defocus curve, with a 4-6 week follow-up after surgery. Refractive outcomes were compared with target values to assess the accuracy of these DOF IOLs.

RESULTS: A total of 90 eyes undergoing cataract surgery received the ETA (n=30) or EA (n=60) IOLs. Postoperative analysis of provisional results confirmed excellent distance and intermediate visual acuity, consistent with the advantages of enhanced monofocal IOLs over standard monofocals. Mean BCDVA was 20/20 or better, and DCIVA was 20/25 or better in more than 80% of eyes. The defocus curve demonstrated an extended range of functional vision, with a range of focus (ROF) exceeding 1.25D at a 0.2 logMAR cutoff, reflecting good intermediate performance. No significant dysphotopsias were reported, reinforcing the optical quality, predictability, and functional benefits of this advanced IOL platform.

CONCLUSIONS: In this study, the enVista ASPIRE™ IOLs, both toric and non-toric, provided high refractive accuracy and good visual acuity at distance and intermediate. These IOLs provide an extended DOF without compromising visual quality or inducing halos and glare, aligning with the characteristics of a partial-ROF enhanced IOL. This suggests these lenses can provide good functional vision across distance and intermediate distances while minimising dysphotopsia.

PURPOSE: To evaluate the visual outcomes of the new refractive Full Range of Vision IOL, LuxLife, in bilateral cataract surgery patients at 6 and 12 months. This study assesses its performance across distance, intermediate, and near visual acuity, refractive error, depth of field, and quality of life. Additionally, it investigates the lens's suitability for toric applications, assessing 6-months rotational stability and centration, aiming to establish LuxLife as a reliable solution for full-range vision post-surgery.

SETTING: Seven clinical centers in Spain and Czech Republic.

METHODS: A multicenter, prospective, non-randomized, open-label study that included cataract patients, aged 50 years or older with no ocular comorbidity, and maximum preoperative corneal astigmatism of 1.0 D. Clinical endpoints include manifest refraction spherical equivalent (MRSE), corrected distance visual acuity (CDVA), uncorrected and distance corrected intermediate visual acuity at 66 cm (UIVA and DCIVA), uncorrected and distance corrected near visual acuity at 40 cm (UNVA and DCNVA), and binocular defocus curve, rotational stability and centration, dysphotopsia and quality of Life using the CatQuest. Patients were followed up for 11-13 months.

RESULTS: 114 patients(age:68±6.9) were bilaterally implanted with the lens. At 6- and 12M the MRSE was -0.13±0.44 and -0.11±0.40 D and binocular UDVA was 0.07±0.1 and 0.08±0.12, UIVA was 0.05±0.1 and 0.06±0.13 and UNVA was 0.06±0.09 and 0.07±0.10 logMAR, respectively. 6M binocular defocus curve at a threshold of 0.2 logMAR of CDVA shows a continuous depth of field exceeding 3.0D. At 6M, the lens demonstrated showed an absolute rotational stability of 3.13±3.54 degrees and absolute decentration pupil of 0.23±0.15 mm from surgery. Patients reported no to some difficulties in their everyday life (90% vs 49%), and especially in reading newspapers (99% vs 40%) and reading price tags while shopping (99% vs 53%), at 6M and preoperatively respectively.

CONCLUSION: The new refractive Full Range of Vision IOL, LuxLife, demonstrated promising clinical outcomes in bilateral cataract surgery patients. At 6 and 12 months, it provided stable visual acuity across distance, intermediate, and near ranges, with minimal spherical equivalent refractive error. At the 0.2 logMAR level, the lens showed a continuous depth of field greater than 3.0D at 6 months. The four-haptic platform confirmed excellent rotational stability and centration, making it suitable for a toric version. Patients reported significant improvements in quality of life, especially in daily tasks. These findings suggest LuxLife is an effective solution for full-range vision.

BACKGROUND: This systematic review and meta-analysis report the long-term efficacy and safety of Excimer Laser Trabeculostomy (ELT) with the AIDA (TUI-Laser AG, Germering, Germany) or ExTra laser system (MLase AG,Germering, Germany) when used as stand-alone or phaco-ELT treatment in open-angle glaucoma (OAG) or OHT patients.

METHODS: A systematic literature search according to PRISMA guidelines was performed by two independent reviewers using PubMed and EMBASE databases to identify published articles that examined the efficacy and safety of the ELT procedure performed in adult patients with glaucoma. Data was extracted after screening articles using a pre-defined patient, intervention, comparison, and outcome (PICO) process. Meta-analysis was performed using R version 4.1.0 with the meta package.

RESULTS: The meta-analysis of key clinical efficacy endpoints showed that stand-alone ELT and phaco-ELT improve visual acuity while reducing medication burden and intraocular pressure (IOP). The improvement in visual acuity was -0.23 LogMAR (95% CI: -0.32, -0.14; n=564) at 1-year follow-up and -0.12 LogMar (95% CI: -0.20, -0.05; n=70) at 2-year follow-up, which was only measured in patients who underwent phaco-ELT. The absolute reduction in glaucoma medication was 0.37 (95% CI: -0.18, 0.92; n=107) at 1-year follow-up and 1.26 (95% CI: 0.74, 1.78; n=95) at 2-year follow-up after standalone ELT. In patients undergoing phaco-ELT, the absolute reduction in glaucoma medication was 0.73 (95% CI: 0.49, 0.97; n=854) at 1-year follow-up and 0.58 (95% CI: 0.33, 0.83; n=130) at 2-year follow-up. The absolute reduction in IOP was 6.18 mmHg (95% CI: 3.69, 8.68; n=127) at 1-year follow-up and 7.10 mmHg (95% CI:6.25, 7.95; n=105) at 2-year follow-up after standalone ELT. In patients undergoing phaco-ELT, the absolute reduction in IOP was 5.41 mmHg (95% CI: 4.12, 6.70; n=847) at 1-year follow-up and 6.72 mmHg (95% CI: 3.01, 10.42; n=130) at 2-year follow-up. The meta-analysis of the key safety endpoints showed a low complication rate and a low rate of additional surgeries following standalone ELT or phaco-ELT.

CONCLUSIONS: This meta-analysis concludes that ELT is an efficacious and safe option. Based upon current reimbursement rates in markets where ELT is available; it is likely that ELT is cost-effective and a potentially cost-saving treatment option for patients with OAG and OHT. Country specific cost-effectiveness modeling performed by payors and HTA bodies may support future coverage and payment decisions when evaluating ELT in the MIGS category.

PURPOSE: This retrospective case series aims to document healthcare providers' (HCP) real-world experience of using the enVista ENVY toric (ETN) intraocular lens (IOL), including satisfaction, IOL utilization patterns, and patient (pt) outcomes.

SETTING: This sub-analysis of a multicenter, cross-sectional, retrospective case series includes case report forms (CRFs) from 10 HCPs from the USA (n=9) and Canada (n=1). Procedures were conducted between September 23, 2024, and December 30, 2024.

METHODS: The ETN IOL provides up to 4 D of continuous visual range with enhanced tolerance to dysphotopsia and can treat corneal astigmatism. HCP participants completed a retrospective user-experience survey. For this sub-analysis, HCPs provided ETN electronic medical record cases using a standardized CRF to document real-world clinical performance. Key outcome measures included monocular and binocular vision outcomes (uncorrected distance visual acuity [UDVA], corrected distance visual acuity [CDVA], uncorrected intermediate visual acuity [UIVA], uncorrected near visual acuity [UNVA]), mean refractive spherical equivalent (MRSE), occurrence of glistenings, and adverse events (AEs).

RESULTS: This sub-analysis includes 50 pts (91 eyes): 9 unilateral pts (n=5 OD); 26% of eyes had ocular comorbidities. Mean±SD preop delta K was 1.24±0.68 (n=89); mean±SD spherical equivalent target was 0.02±0.23 (n=75). Monocular vision outcomes: 93% 20/25 or better CDVA (n=61); 77% 20/25 or better UDVA (n=87); 94% 20/32 or better UIVA (n=49); 89% J2 or better UNVA (n=56). Binocular CDVA of 20/25 or better was achieved in 88% of pts (n=26). Mean±SD MRSE was 0.00±0.15 (n=36). No pts reported glistening. Four pts experienced AEs: epithelial defect OS; mild persistent inflammation OU; subconjunctival haemorrhage OS; one pt experienced significant corneal oedema OU and intraocular pressure spike. Posterior capsule opacification was reported in 3 eyes.

CONCLUSIONS: This multicentre, cross-sectional, retrospective study provides important insights into the real-world clinical performance and vision outcomes of the ETN IOL. In the cases provided, most pts achieved good distance, intermediate, and near vision, with no reported glistening and a low occurrence of reported AEs.

PURPOSE: enVista Envy (EN) and enVista Envy toric (ETN) are full range of vision (FRoV) intraocular lenses (IOLs) that provide 4D of continuous visual range with dysphotopsia tolerance. The present sub-analysis of this multicenter, cross-sectional, retrospective study aims to document ophthalmologists' real-world experience with EN and ETN, focusing on healthcare provider (HCP) satisfaction and IOL utilization patterns.

SETTING: This study includes user experience surveys from 11 HCPs from the USA (n=10) and Canada (n=1) with ≥3 years' experience conducting cataract surgery, and who had completed cataract extraction and EN and/or ETN IOL implantation on ≥5 patients.

METHODS: In this multicenter, retrospective case review, and cross-sectional survey study, HCP participants provided ≥5 EN and/or ETN electronic medical record cases using a standardized case report form to document real-world clinical performance and visual outcomes. They also completed a retrospective user-experience survey about their experience with EN and/or ETN. Survey outcomes included practice characteristics, IOL utilization, and HCP satisfaction with EN and ETN.

RESULTS: In the last year, participating HCPs performed an ~mean±SE of 1191±215 cataract surgeries (n=11); FRoV IOLs were used in ~mean±SE 21.7±6.0% of cases (n=11), including an ~mean±SE of 16±5 EN and 20±8 ETN IOLs, per HCP (n=9). On a scale of 0 (very dissatisfied) to 10 (very satisfied), 91% and 90% of HCPs rated their satisfaction with the overall performance of the EN (n=11) and ETN (n=10) IOLs, respectively, as ≥9. Similar ratings were obtained for most individual lens qualities and outcomes (e.g., rotational stability, centration, glistening-free, and visual outcomes [all distances]). All HCP respondents would recommend EN (n=11) and/or ETN (n=10) to friends and family.

CONCLUSIONS: This multicenter, retrospective case review and cross-sectional survey study provides important insights into real-world IOL utilization patterns, and HCP satisfaction and patient outcomes with the EN and ETN IOLs. HCPs reported high overall satisfaction and high satisfaction across key lens qualities and visual outcomes with EN and ETN IOLs.

PURPOSE: Evaporation and renewal of the tear film can be altered by multiple factors; thus, in dry eye disease, restoring a functional tear film can be a complex challenge. Traditionally, dry eye relief has been provided by water-based artificial tears (ATs), but ATs with lipid components have emerged more recently to provide lubrication while decreasing tear evaporation. This study compared the performance and safety of two preservative-free ATs with sodium hyaluronate (SH) in patients with moderate-to-severe dry eye disease: a multicomponent 0.24% SH eye drop with carbomer and triglycerides as lipids (SH-CB-TG), and an aqueous-based comparator (C-SH) with 0.18% SH.

SETTING: The RESTA (Relief of Eye Surface by Triple Action) study was a multicentre, investigator-masked, noninferiority study conducted at 16 centres in France and approved by an independent ethics committee (CPP SOOM IV: Comité de Protection des Personnes du Sud-Ouest et Outre Mer IV).

METHODS: Following a 2-week washout period with povidone 2%, up to 6 drops daily, participants were randomised 1:1 to receive SH-CB-TG or C-SH. Each study drop was administered 3–6 times daily for a duration of 3 months. The primary endpoint was change from Baseline in the ocular surface fluorescein staining (OSFS) score (0–15 per the Oxford scheme) at Day 28 in the per-protocol population. Secondary endpoints included OSFS at 3 months, tear film break-up time, dry eye symptoms, quality-of-life questionnaire and frequency of AT instillation.

RESULTS: On Day 28, in the SH-CB-TG group (n=45), OSFS score decreased from a Baseline of 5.7±1.2 to 3.6±1.6. In the C-SH group (n=34), it decreased from 5.8±1.3 to 4.3±2.1 (95% confidence interval of the adjusted difference was below the predetermined value for noninferiority). In both groups, signs, symptoms and quality-of-life measures improved continuously through the study, with a favourable safety profile. While not statistically significant, a higher proportion of patients in the SH-CB-TG group (vs. C-SH), strongly agreed that instillation of the study AT was comfortable at all timepoints. In the SH-CB-TG group, the global score of dry eye symptoms showed a statistically significant improvement compared with the C-SH group (p<0.05).>

CONCLUSIONS: The multicomponent, lipid-containing SH-CB-TG was noninferior to the aqueous-based tear substitute in the studied population and may offer additional advantages in ameliorating symptoms of dry eye.

PURPOSE: To evaluate the visual outcomes, spectacle independence and frequency of unwanted visual symptoms following the implantation of a new enhanced monofocal IOL that uses higher-order spheric coefficients on the central part of the posterior surface to broaden the depth of focus.

SETTING: Private Practice in the US.

METHODS: This prospective observational study included 41 patients who underwent bilateral cataract surgery and implantation of a new enhanced monofocal (non-toric/toric) IOL (enVista Aspire, Bausch & Lomb). Patients with amblyopia, AMD, and diabetic retinopathy were excluded. However, patients with prior RK, LASIK, mild drusen or mild glaucoma were allowed to participate. Postoperative assessments included binocular uncorrected visual acuities at distance, intermediate, and near. A short survey comprising questions from the PRSIQ (patient-reported spectacle independence questionnaire) and QoV (quality of vision questionnaire) was used to assess spectacle independence and patient-reported incidence of visual symptoms at 3 weeks postoperatively.

RESULTS: Postoperatively, 98% of patients achieved binocular UDVA of 20/25 or better. 98% had binocular UIVA of 20/32 or better. 90% had binocular UNVA of 20/40 or better. All (100%) enVista Aspire IOL implanted patients were spectacle-independent for distance and could perform distance tasks all of the time without wearing correction. More than 95% of patients were spectacle-independent for intermediate vision. All patients reported that they could function comfortably 'all the time' (83%) or 'most of the time' (17%) without wearing glasses or contacts for intermediate vision. The percentage of patients reporting no or occasional unwanted visual symptoms was 87% (halos), 91% (starbursts), and 74% (glare).

CONCLUSIONS: Implantation of enVista Aspire IOL provided excellent binocular visual acuities, spectacle independence at distance and intermediate. Spectacle independence at near was obtained for almost 1/2 of the patients. The frequency of visual symptoms was also low, with a high proportion of patients reporting no or occasional dysphotopsia.

PURPOSE: The enVista ASPIRE toric (ETA) intraocular lens (IOL) is a hydrophobic acrylic monofocal IOL designed to provide an extended depth of focus (DOF) compared to standard monofocal lenses. These lenses are indicated for primary implantation in the capsular bag to correct aphakia following cataract extraction in adult patients with pre-existing astigmatism. The purpose of this study is to evaluate the visual outcomes at different distances, rotational stability, and defocus curve, to assess the functional benefits of this new platform of enhanced monofocal IOLs.

SETTING: This study is conducted in two sites in Spain (Unidad de cirugía facorrefractiva, Hospital Universitario Miguel Servet, Zaragoza, Spain, and Hospital Universitario Ramón y Cajal, Madrid, Spain) in patients presenting for cataract surgery with pre-existing astigmatism.

METHODS: Prospective, multicenter, clinical study of an enhanced toric monofocal (ETA) IOL in participants undergoing cataract surgery with pre-existing astigmatism. Patients with no previous ocular surgery or serious ocular disease and normoreactive pupil were included. All procedures were femtosecond laser assisted cataract surgeries (Victus, Bausch and Lomb, Inc) with APEX-centered implantation. The clinical outcomes included best-corrected and uncorrected visual acuity at distance (BCDVA and UDVA) and intermediate (DCIVA and UIVA), rotational stability and defocus curve. Follow-up was 4-6 weeks.

RESULTS: 30 eyes implanted with ETA IOLs after cataract surgery with pre-existing astigmatism are included. At 4-6 weeks postoperative, over 80% of eyes achieved BCDVA of 20/20 or better and DCIVA of 20/30 or better at 66 cm. The monocular defocus curve postoperative showed a wide range of functional vision, with a typical enhanced lens performance greater than 1.25 diopters at 0.2 logMAR, which translates into outstanding intermediate performance. Good rotational stability has been demonstrated without modification of the lens position at 1-month and 3-month. No significant dysphotopsias has been reported.

CONCLUSIONS: Our study confirms that the enVista hydrophobic toric platform is a safe and reliable option for correcting corneal astigmatism after cataract surgery, with proven rotational stability. enVista ASPIRE toric IOLs have excellent visual acuity at far and intermediate distances.

PURPOSE: The aim of this study is to assess the mesopic monocular and binocular visual acuity outcomes after cataract surgery with implantation of a novel Full Range of Vision (FRoV) enVista intraocular lens (IOL) or its parent monofocal IOL in US subjects.

SETTING: 23 US clinical sites.

METHODS: Data from this prospective, multicenter, randomized, controlled clinical trial evaluated outcomes after bilateral implantation of a novel full range of vision (FRoV) enVista Envy IOL (Bausch + Lomb) (study group, n=284) or a monofocal enVista IOL (control group, n=142) in patients undergoing cataract surgery. Distance-corrected monocular and binocular visual acuity at intermediate (DCIVA, 66 cm) and near (DCNVA, 40 cm) under mesopic conditions at 120-180 days post-surgery was assessed.

RESULTS: At 120-180 days post-surgery, the mean monocular and binocular mesopic DCIVA was significantly better in the FRoV group (0.29±0.14 vs 0.46±0.16 logMAR and 0.21±0.12 vs 0.39±0.13logMAR, respectively) than in the monocular group (both p>0.0001). Likewise, the mean mesopic DCNVA was also significantly better in the FRoV group (monocular 0.35±+0.15 logMAR vs 0.66±0.18 logMAR and binocular 0.26±0.13 vs 0.59±0.15 logMAR) compared to monofocal group (both p>0.0001).

CONCLUSION: enVista Envy FRoV IOL demonstrated good efficacy under mesopic conditions achieving good binocular DCIVA (20/32) and DCNVA (20/37). Patients implanted with the FRoV IOL showed a mean binocular DCIVA of more than 2 lines better and a mean DCNVA of 4 lines better than the monofocal group.

PURPOSE: To evaluate the safety and effectiveness of laser-assisted in situ keratomileusis (LASIK) performed with Teneo 317 Model 2 using the latest laser ablation algorithm (Proscan 1.28 SW) for the correction of high myopia (-6.0 D or higher).

SETTING: 10 US clinical sites.

METHODS: This prospective, multicenter, open-label, non-randomized, single-arm study included 158 eyes that underwent LASIK with the Teneo 317 Model 2 (version 1.28 US SW, Bausch & Lomb) for the correction of high myopia (-6.0 D or higher). Inclusion criteria were eyes with preoperative best-corrected distance visual acuity (CDVA) of 20/25 or better, manifest refraction spherical equivalent (MRSE) between -6.0 D and -11.50 D with or without astigmatism (cylinder between 0.0 D and -3.0 D). Outcomes were assessed at postoperative 9 months and included uncorrected and corrected distance visual acuity (UDVA, CDVA), MRSE, and astigmatic outcomes. No nomogram adjustments were made, and the patient's manifest refraction was used for the laser treatment.

RESULTS: At postoperative 9 months, UDVA was 20/25 or better in 94.8% of eyes, and 100% achieved UDVA of 20/40 or better. There was a gain of 1 or more lines of CDVA in 32.2% of the eyes, and 67.1% of the eyes showed no change in the lines of CDVA. Mean postoperative MRSE was -0.07 ± 0.39 D compared to -7.96 ± 1.22 D preoperatively, and 87.7% and 98.1% of eyes achieved postoperative MRSE within ±0.50 D and ±1.00 D, respectively. The postoperative refractive cylinder was ≤0.50 D in 90.3% of eyes and ≤1.00 D in 99.4% of eyes. Refractive outcomes were stable from postoperative 3 to 9 months.

CONCLUSION: LASIK performed with the Teneo 317 Model 2 excimer laser for correcting high myopia (with or without astigmatism) was safe and effective, yielding good visual and refractive outcomes that were stable through the last follow-up at 9 months.

PURPOSE: To report the visual performance and patient-reported outcomes after bilateral implantation of a novel Full Range of Vision toric IOL (enVista ENVY) in cataract/refractive lens exchange (RLE) patients with preexisting astigmatism.

SETTING: This was a retrospective study conducted at one site in Canada.

METHODS: This study included cataract patients with preexisting corneal astigmatism who underwent cataract surgery/RLE with bilateral implantation of a novel full range of vision toric IOL (enVista Envy toric, Bausch & Lomb). Outcome measures included visual acuities at distance (BCDVA, UCDVA), intermediate (UCIVA) and near (UCNVA) on Early Treatment Diabetic Retinopathy Study (ETDRS) charts, refractive and astigmatic outcomes, and assessment of patient-reported dysphotopsias. Patients were excluded if they had vision-limiting ocular comorbidities.

RESULTS: Twenty-nine eyes (16 toric) of 20 patients were evaluated after a minimum of 28 days. Mean BCDVA was −0.017 logMAR, with 90% of eyes achieving 20/20 or better. Mean UCDVA was 0.041 logMAR with 66% of eyes achieving 20/20 or better, and 86% of eyes achieving 20/25 or better. Mean UCIVA was 0.061 logMAR with 86% of eyes achieving 20/25 or better. UCNVA was 0.060 logMAR with 83% of eyes achieving 20/25 or better. For toric eyes, 100% had ≤0.75D residual cylinder and 88% ≤0.25D. Only one patient reported any of glare, haloes, or starbursts to be more than mildly bothersome (starburst).

CONCLUSIONS: At 28 days or more, the enVista ENVY and ENVY Toric lenses demonstrated excellent uncorrected visual acuities at distance, intermediate, and near. Eyes implanted with ENVY Toric had consistently low rates of residual cylinder. Patient reported outcomes indicated low rates of bothersome dysphotopsias.