PURPOSE: To evaluate clinical outcomes, visual acuity, and the range of vision in patients implanted with the enVista Aspire “monofocal plus” intraocular lens (IOL), designed to provide an extended range of vision through a proprietary aspheric surface.

SETTING: Single-Center in Poland

METHODS: This prospective clinical study included 64 eyes of 32 patients who underwent bilateral cataract surgery with implantation of the enVista Aspire IOL. Standard phacoemulsification was performed in all cases. Outcome measures assessed at 3 months postoperatively included uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA) at 66 cm, and manifest refractive spherical equivalent (MRSE). Patient satisfaction and the presence of photic phenomena (glare and halos) were evaluated using a standardized questionnaire.

RESULTS: Postoperative refractive outcomes demonstrated high predictability, with a mean MRSE of −0.28 ± 0.46 D. Visual performance was excellent at both distance and intermediate ranges. Mean binocular postoperative UDVA was 0.03 ± 0.03 logMAR (20/20 Snellen equivalent), while mean binocular postoperative UIVA at 66 cm was 0.22 ± 0.10 logMAR (approximately 20/32 Snellen equivalent), indicating a smooth transition between distance and intermediate vision. The mean postoperative sphere was −0.24 ± 0.45 D, and the mean prediction error (PRA) was 0.46 ± 0.53 D. No significant intraoperative or postoperative complications were observed, and no clinically relevant photic phenomena were reported during the follow-up period.

CONCLUSIONS: The enVista Aspire IOL delivers excellent visual outcomes, achieving full restoration of distance vision and functional intermediate visual acuity. The lens demonstrates high refractive predictability and provides an extended range of vision suitable for modern intermediate visual demands, without the visual disturbances commonly associated with multifocal IOLs. It represents an effective and reliable “monofocal plus” option for cataract surgery.

PURPOSE: To determine the visual, refractive, and patient-reported outcomes after bilateral implantation of enVista Aspire intraocular lens (IOL), targeted for either bilateral emmetropia or mini-monovision.

SETTING: 7 sites in the United States

METHODS: This noninterventional, prospective, multicenter study included 140 eyes of 70 patients who had undergone bilateral implantation of enVista Aspire enhanced monofocal IOL (Bausch and Lomb). Of these 70 patients, 49 patients (98 eyes) were targeted for emmetropia in both eyes (defined as ≤0.5 D manifest refraction spherical equivalent (MRSE) (BE group), and 21 patients (42 eyes) were targeted for mini-monovision (emmetropia in one eye and myopia of more than -0.50 D MRSE in the other) (MM group). MRSE, monocular uncorrected distance visual acuity (UDVA), uncorrected intermediate (UIVA), and patient-reported outcomes using Near Activity Visual Questionnaire (NAVQ) were evaluated at postoperative 60-270 days after the second eye surgery.

RESULTS: Postoperatively, the BE group had a mean MRSE of -0.15±0.26 D, UDVA of 0.06±0.12, and UIVA of 0.24±0.15 logMAR. UDVA and UIVA of 20/32 or better were achieved in 94.9% and 52.0% of eyes, respectively. In the emmetropic eyes of the MM group, 85.7% had a UDVA of 20/32 or better with a mean MRSE of -0.33±0.17 D and UDVA of 0.11±0.12 logMAR; in the myopic eyes of the MM group, 90.5% had a UIVA of 20/32 or better with a mean MRSE of -0.96±0.34 D and UIVA of 0.13±0.09 logMAR. Per NAVQ outcomes, 71-81% patients in the MM group versus 57-61% in the BE group could perform intermediate vision tasks without spectacles. In the MM group, 76.2% patients (versus 59.2% in the BE group) were satisfied with their near vision.

CONCLUSIONS: Patients targeted for bilateral emmetropia achieved excellent distance visual acuity, while those with mini-monovision experienced enhanced intermediate visual acuity. Among patients targeted for mini-monovision, 14-20% more patients reported no or minimal difficulty with intermediate vision-related tasks, and 17% more were satisfied with their near vision compared with those targeted for bilateral emmetropia. These results indicate that, when targeted for mini-monovision, the enVista Aspire IOL provides additional benefits for intermediate vision and greater patient satisfaction with near vision.

PURPOSE: Enhanced monofocal intraocular lenses (IOLs) are designed to extend depth of focus (DOF) compared to traditional monofocal lenses. The enVista ASPIRE Toric (ETA) and enVista ASPIRE (EA) IOLs are hydrophobic acrylic enhanced monofocal IOLs that have demonstrated up to 1.25 D of continuous DOF in clinical trials. This study aimed to evaluate the real-world performance and outcomes of ETA and EA IOLs.

SETTING: This was a prospective, real-world study conducted at two sites in Spain (Unidad de cirugía facorefractiva, Hospital Universitario Miguel Servet, Zaragoza and Hospital Universitario Ramón y Cajal, Madrid). Surgeries were performed by two investigators in patients between 21 January 2025 and 16 December 2025.

METHODS: Postoperative visual performance was assessed in patients implanted with EA and ETA IOLs. All procedures utilised femtosecond laser–assisted cataract surgery (Victus, Bausch & Lomb, Inc.), with consistent APEX-guided centration of the implants. Clinical outcomes included corrected and uncorrected distance visual acuity (CDVA and UDVA), uncorrected intermediate distance visual acuity (UIVA), refractive outcomes (manifest refraction spherical equivalent [MRSE], spherical equivalent [SEQ], manifest refraction cylinder), and a defocus curve. Outcomes were assessed at 4–12 weeks postoperatively. Safety was also monitored.

RESULTS: A total of 80 patients (98 eyes; 54% OD) were included; median follow-up was 34 days (n=42). Mean±standard deviation (SD) age was 69±9 years (n=33) and mean±SD SEQ target was −0.08±0.13 D (n=95). Monocular outcomes were CDVA of 0.1 logMAR or better in 99% of eyes (92/93), UDVA of 0.1 logMAR or better in 74% (69/93), and UIVA of 0.3 logMAR or better in 68% (61/90). Mean±SD MRSE was −0.18±0.38 D (n=94), mean±SD SEQ difference compared with target values was 0.11±0.38 D (n=93), and manifest refraction cylinder was −0.37±0.31 D (n=94). The defocus curve demonstrated an extended DOF, with a functional range of approximately 1.25 D at a 0.2 logMAR cutoff, reflecting good intermediate performance. No significant dysphotopsias were reported.

CONCLUSIONS: In this real-world study, EA and ETA IOLs provided high refractive accuracy and good distance and intermediate visual acuity. The defocus curve also demonstrated an extended DOF without compromising visual quality.

PURPOSE: This study documents real-world patient characteristics, utilisation patterns and clinical outcomes with two different preservative-free lubricating eye drops: Artelac Complete (ArtC) – which contains 0.24% sodium hyaluronate (HA), carbomer and glycerin – and Artelac Ultra 4S (Art4S), which contains HA, trehalose, fucoidan and D-panthenol.

SETTING: This retrospective, multi-country, cross-sectional case review study included currently licensed eye care practitioners (ECPs) with ≥3 years' experience treating patients with dry eye disease (DED), and ≥1 year's experience with at least one of the study drops (ArtC, Art4S).

METHODS: ECPs provided a deidentified, retrospective convenience sample of ≥5 study-drop cases using a standardised case report form. ECPs also completed a survey about their experience. Outcomes included tear film break-up time (TBUT), tear production (Schirmer test), ECP- and patient-reported changes in DED signs/symptoms, ECP-rated effectiveness, tolerability and adverse events (AEs). The study protocol received central institutional review board exemption. An interim analysis was conducted on the results from 10 ECPs (based in Germany, Italy, Poland, Spain, Turkey, and UAE) covering 59 patients treated with ArtC and 19 patients treated with Art4S.

RESULTS: Patients were predominantly female (ArtC, 68%; Art4S, 84%) and not wearers of contact lenses (ArtC, 88%; Art4S, 74%). From diagnostic visit to last available follow-up (mean [SE] 9.6 [1.2] weeks for ArtC, 22.6 [2.8] weeks for Art4S) improvements were reported for TBUT (mean [SE] 5.0 [0.4] seconds for ArtC, 4.4 [0.5] seconds for Art4S) and Schirmer test (mean [SE] 2.8 [0.6] mm for ArtC, 3.3 [1.4] mm for Art4S). ECPs reported improvements in ArtC patients' signs (59/59) and symptoms (51/59), and in Art4S patients' signs (19/19) and symptoms (19/19). 57/59 patients treated with ArtC and all patients treated with Art4S reported symptom improvement. No AEs were reported with ArtC; one patient reported an AE (atopia on lids) with Art4S.

CONCLUSIONS: In this interim retrospective real-world case review, both ArtC and Art4S were associated with improvements in tear film stability, tear production and ECP-/patient-reported DED outcomes. Expanded real-world data from the complete study will further explore these findings.

PURPOSE: To synthesize and contextualize recent evidence on over-the-counter (OTC) artificial tears (AT) for dry eye disease (DED), focusing on how ingredient and delivery innovations target tear-film instability, hyperosmolarity, inflammation, and evaporation; and how formulation choice can be individualized within the TFOS DEWS III management framework.

SETTING: This context for this analysis is the eye-care practice where DED is managed as a chronic, multifactorial ocular surface disorder. The scope emphasizes first-line, widely accessible OTC tear supplementation and patient lifestyle/environmental triggers.

METHODS: TFOS DEWS III guidance and peer-reviewed literature on tear-film structure and AT performance were reviewed. Evidence was qualitatively synthesized across formulation classes (polymer demulcents/viscosity enhancers, osmoprotectants, lipid emulsions/liposomes, antioxidant/vitamin additives, and preservative or preservative-free delivery systems) and mapped to DED phenotypes and practical use considerations.

RESULTS: ATs are foundational in DED, but formulations are not interchangeable. Polymer demulcents/viscosity enhancers (eg, carboxymethylcellulose, hydroxypropyl methylcellulose, hyaluronic acid, hydroxypropyl guar) increase lubrication and retention. Osmoprotectants (trehalose, erythritol/L-carnitine, ectoine, glycerol) counter hyperosmolar stress. Lipid-based systems (oil emulsions, phospholipid nanoemulsions, liposomal sprays) replenish the lipid layer for evaporative DED/meibomian gland dysfunction, but with possible transient blur. Antioxidant/vitamin additives (vitamin A or B12) have emerging evidence. Combination drops blend classes to target multiple mechanisms. Preservative-free or “vanishing” preservatives are favored for frequent dosing.

CONCLUSIONS: A patient-centered approach that links DED phenotype and triggers to AT formulation (aqueous-supporting polymers, hyperosmolarity-targeting osmoprotectants, and lipid supplementation for evaporative disease) can improve comfort and long-term control. Clinicians should consider preservative exposure, dosing burden, bottle usability, contact-lens wear, and cost to maximize adherence. Future well-designed comparative studies using consistent DED definitions and outcomes are needed to define optimal ingredient combinations, concentrations, and dosing strategies.

PURPOSE: Ectoine is a natural molecule originally found in extremophilic bacteria as an osmolyte, a low molecular weight compound that helps regulate osmotic pressure and maintain cellular homeostasis. Ectoine forms a net-like structure that surrounds macromolecules with a shield of water, protecting cells against environmental stressors including dryness. As such, there is growing interest in ectoine as an osmoprotectant for dry eye. This study compared a novel, preservative-free drop combining 2.0% ectoine and 0.25% hyaluronic acid (ArtE) with an existing, widely used eye drop, containing 0.1% hyaluronic acid (HA) in the treatment of mild-to-moderate dry eye disease (DED).

METHODS: At baseline, patients chose ArtE or HA drops; recruitment was limited per site and stratified by baseline TBUT (<5 vs >5 s) to avoid bias. Both products were used 1-2 drops/eye up to 6 times/day for 28 (+3) days. The primary endpoint was change in TBUT in the 'decisive eye', analysed for non-inferiority (Δ=25% of reference mean) using ANCOVA adjusting for baseline TBUT, centre and gender. Change in TBUT was also evaluated by a t-test for each treatment separately. Secondary endpoints included patient- and investigator-assessed symptom/clinical-sign scores, ocular surface disease index (OSDI), tear flow (Schirmer II test), corneal fluorescein staining (CFS), global efficacy/tolerability, adverse events (AEs) and compliance.

RESULTS: 75 adults were treated (ArtE n=35; HA n=30). ArtE met the pre-determined non-inferiority criterion versus HA for the primary endpoint. Assessing each treatment separately, in the decisive eye, mean TBUT increased by 2.5 s with ArtE (p=0.0010) and by 1.1 s with HA (p=0.1686). Symptoms/clinical signs and quality of life improved in both groups (mean total OSDI change, ArtE vs HA, was -17.5 vs -17.2). Tear flow increased from baseline by 1.8 vs 0.8 mm/5 min (ArtE vs HA). No serious AEs occurred; of 6 AEs reported, 5 (all considered severe: headache, ataxia, and bilateral eye pain) occurred in 1 patient with several comorbidities. Overall, tolerability was rated as 'very good'; 79.4% and 71.4% would continue use with ArtE and HA, respectively.

CONCLUSIONS: In routine care, preservative-free ArtE eye drops were comparable to HA drops over 4 weeks of treatment. Both treatments improved symptoms and OSDI-measured quality of life and were well tolerated with few, non-serious adverse events.

PURPOSE: To evaluate the real-world clinical performance of the enhanced monofocal enVista Aspire and Aspire Toric intraocular lenses (IOLs) and to assess surgeon and subject satisfaction in subjects undergoing bilateral cataract surgery. The enhanced monofocal IOL is a one-piece hydrophobic acrylic IOL with a posterior squared step edge and modified C-Loop design; the enVista Aspire IOL uses an optical modification of the posterior aspheric surface to create a small continuous increase in IOL power within the central 1.5 mm diameter to slightly broaden the depth of focus from distance to intermediate.

SETTING: 57 sites in the United States.

METHODS: This was a prospective, multicenter, open-label, single-arm, post-market clinical study. Subjects scheduled for bilateral implantation in cataract surgery were enrolled and screened for eligibility through a chart review (Preoperative Visit 0). To be eligible, subjects needed to be 22 years of age or older, with a CDVA equal to or worse than 20/40 in each eye, clear intraocular media other than the cataract in both eyes and stable refraction in contact lens users. Exclusion criteria included any corneal pathology, anterior segment pathology (eg, pseudoexfoliation syndrome, synechiae, iris atrophy), glaucoma, retinal detachment or retinal pathology, congenital ocular anomaly, and previous intraocular or corneal surgery. Postoperatively, all eyes underwent ophthalmic examinations at regular intervals through Postoperative Visit 1 (14 to 42 days after second eye IOL implantation). Performance endpoints included monocular and binocular uncorrected and corrected visual acuity at distance (UDVA, CDVA), intermediate (UIVA, DCIVA) and near (UNVA, DCNVA), patient-reported outcomes (AIOLIS, NAVQ and VISIBL) and ocular adverse events.

RESULTS: A total of 313 subjects underwent bilateral implantation with the study IOLs; three subjects were discontinued after IOL implantation, thus 310 subjects were analyzed. The study was conducted by 57 Principal Investigators (84 implanting surgeons). Mean binocular CDVA was -0.03 ± 0.07 logMAR, with 97.7% of patients achieving 20/25 or better. Mean binocular UDVA and UIVA were 0.02 ± 0.10 and 0.20 ± 0.15, respectively. While 90.6% of eyes achieved binocular UDVA of 20/25 or better, 70.9% of eyes achieved UIVA of 20/32 or better. Mean binocular DCIVA was 0.23 ± 0.16, with binocular DCIVA of 20/32 or better achieved in 64.4% of eyes. The AIOLIS demonstrated that 89.6% of subjects were satisfied with their vision; overall, 92.5% of subjects reported that their vision was good to excellent, 92.6% were seeing pretty well or better without corrective devices, and 86.7% rated their intermediate vision as good or better without corrective devices. Analysis of NAVQ responses showed that 70-72% of patients could perform intermediate vision tasks without spectacles, such as viewing a computer or mobile device display, with 'no or a little difficulty', and 72% of patients were satisfied with their near vision. Most ocular adverse events were considered related only to the study procedure, and not the study device.

CONCLUSIONS: This open-label post-marketing study demonstrated excellent safety and efficacy for the enVista Aspire and enVista Aspire Toric IOLs. Patients achieved good distance visual acuity with functional intermediate visual acuity, showing a broadened depth of focus, and a high percentage of patients were satisfied with their vision.

PURPOSE: To assess and compare pre-clinical glare phenomena, quantified by the straylight parameter, in the latest generation of presbyopia-correcting intraocular lenses (IOLs) from different manufacturers using a clinical straylight measurement system adapted for in vitro evaluation.

SETTING: David J. Apple Center for Vision Research, Department of Ophthalmology, University Eye Clinic Heidelberg, Heidelberg, Germany.

METHODS: A total of 18 IOLs were analyzed (6 groups, n = 3 per group), all with a nominal power of +20.0 D. Tested lenses included enVista Monofocal (Bausch + Lomb), enVista Envy (Bausch + Lomb), LuxLife (Bausch + Lomb), TECNIS Odyssey (Johnson & Johnson Vision), Clareon PanOptix Trifocal (Alcon), and FINEVISION HP (POD F GF) (BVI Medical). The potential of the IOLs to induce glare was quantified by means of forward light scattering using a C-Quant straylight meter (Oculus GmbH, Germany) adapted for in vitro assessment. Straylight was measured at visual angles of 2.5°, 3.5°, and 7°. The logarithm of the straylight parameter (logs) was used for analysis and reported in clinical log units; higher logs values are associated with increased perception of glare and larger halo size. Published straylight values of isolated crystalline lenses were used as physiological references.

RESULTS: At 7°, all IOLs demonstrated low straylight values (<0.3 logs), comparable to or below those of a young crystalline lens. At smaller visual angles (2.5° and 3.5°), angular dependency differed according to optical design. The monofocal enVista and the refractive trifocal IOL (LuxLife) showed consistently low straylight across all angles (≤0.3 logs). Among diffractive trifocal IOLs, enVista Envy and FINEVISION HP (POD F GF) maintained low and stable values. In contrast, TECNIS Odyssey exhibited elevated straylight at 2.5° and 3.5° (nearly 1.1 logs), approaching values reported for an aged crystalline lens, followed by a reduction at 7°. Clareon PanOptix demonstrated a moderate elevation at smaller angles.

CONCLUSIONS: Assessment at multiple visual angles reveals design-related differences in straylight, and thus glare perception, that are not detectable at 7° alone. Small-angle straylight differs among trifocal designs; the TECNIS Odyssey shows higher straylight at smaller angles, closer to a glaring source. By contrast, enVista Envy and FINEVISION maintained low straylight levels, close to those of the refractive IOLs.

PURPOSE: This study aimed to evaluate the safety and effectiveness of the excimer laser trabecular bypass minimally invasive glaucoma surgery (MIGS) system in reducing the intraocular pressure (IOP) of adults with mild-to-moderate primary open-angle glaucoma (POAG) when used in combination with cataract surgery. The present analysis reports on the safety outcomes of the trial.

SETTING: This was a prospective, non-randomised, trial at 20 sites in the USA (NCT04899063), with treatment between June 2021 and July 2023

METHODS: The ELIOS system is a clinically validated excimer laser trabecular bypass MIGS procedure. Key eligibility criteria included age ≥45 years, mild-to-moderate POAG, an operable age-related cataract eligible for PE with best-corrected visual acuity of 20/40 or worse, medicated IOP of ≤24 mmHg and unmedicated diurnal IOP (DIOP) of 22–34 mmHg. Eligible patients underwent the MIGS procedure after uncomplicated cataract surgery. Safety assessments included ocular adverse events (AEs), endothelial cell density (ECD) loss from baseline, and postoperative BCVA through the follow-up period. These results correspond to the evaluations conducted at the 12-month follow-up.

RESULTS: A total of 318 pts underwent the procedure. Mean±SD age was 70.2±7.4 years (54% female). 5 AEs were reported during cataract extraction/IOL implantation, and no intraoperative complications or AEs were reported during the ELIOS procedure. 144 ocular AEs were documented in 107 pts (33.6%) through 12-mo follow up. Most events occurred within the first postoperative month (68%) and were mild to moderate without clinically significant sequelae. While early postoperative IOP elevations ≥10 mmHg were predominantly transient, the incidence of sustained or later-onset IOP elevation (≥1 month) was low at 1.5%. ECD loss demonstrated early postoperative reduction with stabilization by Month 3. BCVA ≥20/40 was achieved in all patients at 12-mo

CONCLUSIONS: The ELIOS excimer laser trabeculostomy procedure demonstrated a favourable long-term safety profile when combined with cataract surgery in patients with POAG. The low rate of serious ocular adverse events, absence of intraoperative complications, and stable endothelial cell outcomes support its use as a minimally invasive option for enhancing aqueous outflow during cataract surgery. These findings align with reported safety outcomes for standalone phacoemulsification and reinforce the clinical relevance of this combined approach.

PURPOSE: Glaucoma treatment focuses on intraocular pressure (IOP) reduction to prevent the progressive visual damage characteristic of glaucoma. Excimer laser trabeculostomy is a minimally invasive glaucoma surgery (MIGS) that allows precise removal of tissue with a minimal wound-healing response. The ELIOS device (Bausch+Lomb) creates ten 210-μm diameter microchannels in the trabecular meshwork to lower IOP and reduce the risk of progressive visual field loss. The purpose of this study was to evaluate the progression of glaucoma after combined ELIOS and phacoemulsification (phaco) in patients with open-angle glaucoma (OAG) over a five-year follow-up in a real-world setting.

SETTING: This was a retrospective, single-centre study of patients with mild-to-moderate OAG with visually significant cataracts requiring surgery. Combined phaco-Elios procedures were performed between October 2019 and December 2020.

METHODS: The ELIOS procedure uses a 308-nm XeCL excimer laser to create ten 210-µm diameter microchannels in the TM within a 90–110° treatment area to optimise aqueous outflow. Outcomes included visual field damage mean deviation in dB as measured by Humphrey Field Analyzer 3 and mean peripapillary retinal nerve fibre layer thickness (PRNFLT) as measured by Heidelberg Spectralis OCT each year from baseline through 5 years of follow-up. A total of 73 eyes of 59 patients were included in the analysis, with a mean±standard deviation (SD) age of 74±9.2 years, and 45% were male.

RESULTS: At baseline, glaucoma severity was classified as mild (65%), moderate (20%), or severe (15%). Mean±SD visual field deviation was −5.38±5 dB. Overall mean±SD PRNFLT was 82.5±17.2 μm (84.6 for mild, 75.8 for moderate, and 70.5 μm for severe glaucoma). At 5 years of follow-up, the mean±SD field deviation was −4.81±6 dB, corresponding to an overall 11% improvement (p=0.73). The change for mild, moderate, and severe glaucoma was −0.9, +2.4, and +3.0 dB, respectively. Mean±SD PRNFLT was 82.9±17.6 μm at 1 year, then decreased by 0.58 μm each year to 79.6±18.6 μm at 5 years (p<0.001). The change for mild, moderate, and severe glaucoma was −2.3, +2.9, and −6.2μm, respectively. No major adverse events were recorded during follow-up.

CONCLUSIONS: In this study of patients with OAG undergoing phaco-Elios, there was an improvement in mean field deviation and a significant improvement in the rate of PRNFLT decrease compared with the expected decrease for patients with glaucoma. The decrease in PRNFLT values and field deviation were close to physiological normal (up to 0.5 μm/year and −0.2 dB/year, respectively), demonstrating the effectiveness of phaco-Elios in reaching the primary goal of glaucoma treatment, which is to prevent vision loss beyond that of normal ageing. The follow-up at 5 years demonstrates this effect is durable without further intervention. Additional data with more eyes is needed to validate these findings further.

PURPOSE: Excimer laser trabeculostomy is a minimally invasive glaucoma surgery (MIGS) that enables precision removal of trabecular meshwork (TM) to facilitate aqueous outflow without collateral damage. The ELIOS device (Bausch+Lomb) creates microchannels in the TM, with clinical trial data showing sustained reduction in intraocular pressure (IOP) and IOP-lowering medications (meds); both are important treatment goals in glaucoma. The purpose of this study was to evaluate the long-term effectiveness of ELIOS combined with phacoemulsification (phaco) in patients with elevated IOP over a five-year follow-up in a real-world setting.

SETTING: This was a retrospective, single-centre study of patients with mild-to-moderate open-angle glaucoma (OAG) or ocular hypertension (OHT) with visually significant cataracts requiring surgery. Combined Phaco-Elios procedures were performed between October 2017 and December 2021.

METHODS: The ELIOS procedure uses a 308-nm XeCL excimer laser to create ten 210-µm diameter microchannels in the TM within a 90–110° treatment area to optimise aqueous outflow. Outcomes included mean IOP, mean meds, distribution of meds, and best-corrected visual acuity (BCVA) through 5 years of follow-up. Success was defined by three criteria: A. IOP reduction ≥20% without further surgery; B. IOP ≤18 mmHg without meds; C. IOP ≤ preoperative IOP without meds. Safety was also assessed. A total of 129 eyes of 96 patients were included in the analysis, with a mean±standard deviation (SD) age of 73.02±23 years, and 72% were female.

RESULTS: At baseline, mean±SD meds was 1.74±0.75, BCVA was 0.4±0.15 (decimal), non-medicated IOP was 25.44±4.15 mmHg (n=129 eyes), and medicated IOP was 20.8±0.32 mmHg. At 5 years of follow-up, mean±SD medicated IOP was 17.5±0.37 mmHg, corresponding to a 16% reduction (p<0.001). Mean±SD meds was 0.50±0.68, corresponding to a 71% reduction (p<0.001), with 62% of patients requiring 0 meds and 0% requiring ≥3 meds. Mean BCVA was 0.8 decimal (p<0.001). The cumulative success rate was 47.1%, 57.5%, and 65.0%, at 1 year, and 41.4%, 38.0% and 41.4% at 5 years, for the A, B, and C criteria, respectively. Nine cases (7%) required additional surgery by 5 years of follow-up. No major adverse events were recorded. Three patients were lost to follow-up by study end.

CONCLUSIONS: In this study of patients with OAG and OHT undergoing phaco-ELT, the mean IOP was reduced to below the European Glaucoma Society suggested target range for early glaucoma (<20 mmHg and ≥20% reduction) and approaching that for mild-to-moderate glaucoma (<17 mmHg and ≥30% reduction), demonstrating a clinically meaningful outcome. The sustained reduction in meds decreases reliance on medication adherence to sustain outcomes and is associated with improved patient quality of life, which is an important treatment goal. These outcomes are reflected in the three predefined success criteria being met and maintained through 5 years. BCVA was also improved at 5 years.

PURPOSE: This study aimed to evaluate the effectiveness and safety of the excimer laser trabecular bypass minimally invasive glaucoma surgery (MIGS) system in reducing the intraocular pressure (IOP) of adults with mild-to-moderate primary open-angle glaucoma (POAG) when used in combination with cataract surgery. The present analysis reports the effectiveness outcomes of the trial at 12-mo.

SETTING: This was a prospective, non-randomised, clinical trial at 20 sites in the USA (NCT04899063), with treatment between June 2021 and July 2023

METHODS: The ELIOS system (Bausch + Lomb) is a clinically-validated excimer laser trabecular bypass MIGS procedure. Key eligibility criteria included age ≥45 years, mild-to-moderate POAG, an operable age-related cataract eligible for PE with best-corrected visual acuity of 20/40 or worse, medicated IOP of ≤24 mmHg and unmedicated diurnal IOP (DIOP) of 22–34 mmHg. Eligible patients underwent the MIGS procedure after uncomplicated cataract surgery. The co-primary effectiveness endpoints were the proportion of patients achieving a decrease in medication-free mean DIOP of ≥20%, and mean change in medication-free DIOP, from baseline to 12 months.

RESULTS: A total of 318 pts with mean±standard deviation (SD) age of 70.2±7.4years (54% female) underwent the ELIOS combined procedure. At screening, mean±SD medicated IOP was 17.05±3.01mmHg; at baseline, unmedicated DIOP was 24.53±2.51mmHg. 84.2% of patients achieved a ≥20% decrease in unmedicated mean DIOP from baseline at 12mo, meeting the co-primary effectiveness endpoints (97.5% CI 79.59, 88.84; p=0.0116 vs performance goal of >79%). Mean DIOP change was −8.17mmHg (97.5% CI −8.65, −7.69; p<0.0001 vs performance goal of ≤−7.2 mmHg). From screening to Month 11, the mean±SD number of medications decreased from 1.5±0.7 at screening (N=318) to 0.2±0.7 at Month 11 (n=298), accompanied with sustained decrease in IOP throughout the follow-up.

CONCLUSIONS: In this clinical trial of pts with POAG undergoing cataract surgery in combination with the ELIOS procedure, both co-primary effectiveness endpoints were met. ELIOS demonstrated clinically meaningful and sustained reduction in unmedicated DIOP. The 34.5% reduction in mean DIOP at Month 12 aligns with recommended target reduction for mild-to-moderate glaucoma (≥25% reduction to below 17 mmHg). These results suggest the ELIOS procedure is an effective minimally invasive treatment option for reducing IOP in POAG patients undergoing cataract surgery.

PURPOSE: The purpose of this study was to assess the effectiveness of excimer laser trabeculostomy (ELT) using the ELIOS device in reducing intraocular pressure (IOP) in patients with glaucoma undergoing cataract surgery. ELIOS uses a precision non-thermal 308 nm XeCL excimer laser system to create 210-μm diameter microchannels in the trabecular meshwork, without the use of a retained device, and with minimal tissue damage at the periphery of the ablation zone. This enables effective IOP lowering while preserving the delicate physiology of this structure. ELIOS is considered an established option for experienced cataract surgeons considering the introduction of glaucoma surgery into their practice. ELIOS has been CE-marked in Europe since 2014.

SETTING: This was a retrospective, non-randomized 18-month clinical trial conducted at one site in Italy. Surgeries were performed by one investigator between 04 October 2023 and 03 December 2024.

METHODS: Eligible patients were aged ≥45, with primary or secondary glaucoma regardless of stage, medicated IOP of ≥20 mmHg, and phakic eyes requiring cataract surgery. All patients underwent cataract surgery followed by ELIOS. Patients with previous glaucoma surgery were excluded. Number of medications, IOP, visual acuity, and cup-to-disc ratio (C/D) were assessed at baseline, 6 months, 12 months, and 18 months.

RESULTS: A total of 44 patients (50 eyes) underwent the procedure (mean±SD age 74±8years). At baseline, mean±SD medicated and unmedicated IOP was 16.0±5.0mmHg and 25.4±7.0mmHg, respectively, number of medications was 2.9±1.0, BCVA was 0.26±0.20 logMAR, and C/D was 0.70±0.20. Compared with unmedicated baseline, mean±SD IOP at 6 (n=50), 12 (n=39), and 18 months (n=28) was 13.5±3.1mmHg, 13.3±2.9mmHg, and 14.6±3.0mmHg, respectively, corresponding to a 43%, 44%, and 41% reduction, all p<0.001. Mean±SD number of medications was 0.7±1.0, 0.6±1.0, and 0.5±0.9, respectively. At last follow-up, 32 patients (69.6%) were on zero medications, mean±SD BCVA was 0.06±0.15 logMAR, and C/D was 0.68±0.20. One eye had loss of ≥2 Snellen lines.

CONCLUSIONS: These results demonstrate a clinically meaningful reduction in IOP, below the EGS-recommended targets for mild-to-moderate disease (≥25% reduction to below 17 mmHg). The reduction in number of medications overall and the number of patients on zero medications also demonstrates a potential improvement in QoL. As adherence to medication is often poor in patients with glaucoma, reducing the number of required medications represents an important indicator of treatment utility. Further data are required to assess the safety profile of the combined procedure compared with phacoemulsification alone, to further demonstrate the clinical utility of the ELIOS device.