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This study was undertaken to evaluate the safety and efficacy of CSF-1 (0.4% pilocarpine hydrochloride ophthalmic solution) for use in individuals with presbyopia. Two Phase 3 multicenter, randomized, double-masked, vehicle-controlled, parallel-group clinical trials were conducted in 35 private ophthalmology clinics in the United States from October 2020 to February 2022. Key inclusion criteria were the following: (1) age 45–64 years, (2) distance-corrected near visual acuity (DCNVA) at 40 cm ≥0.40 and ≤0.90 logarithm of the minimum angle of resolution (logMAR, approximately 20/50–20/160 Snellen) in at least 1 eye, (3) manifest refraction (MR) between –4.50 and +2.00 diopter (D) sphere in each eye with ≤2.00D difference between eyes, (4) <2.00D of cylinder MR in each eye, (5) ≤0.04 logMAR (20/20–2 or better) corrected distance visual acuity (CDVA) at 4 m in each eye. Key exclusion criteria were the following: (1) >0.14 logMAR (7 letters) improvement in post-vehicle treatment in monocular DCNVA in either eye at visit 1, (2) introcular pressure (IOP) <9 or >22 mm Hg, (3) average dark-adapted pupillometry <3.5 mm in either eye, (4) prior refractive surgery or intraocular lens (IOL) implantation. Participants applied CSF-1 or vehicle twice per day for 2 weeks. Efficacy and safety assessments were performed at several times on days 1, 8, and 15. Response was defined as ≥3-line gain in DCNVA without loss of ≥1-line in CDVA in the study eye under mesopic room lighting conditions. The primary efficacy endpoint was measured 1 hour post-dose 1 on day 8. Key secondary endpoints were 2 hours post-dose 1, and 1 and 2 hours post-dose 2, also on day 8. Safety endpoints were ocular and non-ocular treatment-related adverse events (TRAE), conjunctival redness, drop comfort, slit-lamp biomicroscopy, intraocular pressure, indirect fundoscopy, and CDVA at 4 m. Six hundred thirteen participants were randomized to CSF-1 (n = 309) or vehicle (n = 304). Participants were predominantly White (80.8%) and female (62.0%), with mean age (standard deviation) of 54.7 (4.8). CSF-1 met the primary and key secondary endpoints. At the primary endpoint, 40.1% of the CSF-1 group achieved response versus 19.1% of the vehicle group (P < 0.0001). The percentage of responders was significantly greater in CSF-1 compared with vehicle at all tested times. Changes from baseline in all safety endpoints were comparable between groups. Most adverse events (AEs) were mild and transient. Neither serious nor severe AEs were reported with CSF-1. CSF-1, a low-dose pilocarpine ophthalmic solution, demonstrated superiority to vehicle in improving near vision in individuals with presbyopia without compromising distance vision. CSF-1 demonstrated a favorable safety profile. ClinicalTrials.gov identifier: NCT04599933 (NEAR-1), NCT04599972 (NEAR-2).

PurposeIntraocular lens designs are constantly evolving, trying to obtain more spectacle independence after cataract surgery. This advantage can be linked to some disadvantages, such as optical quality decrease. For that reason, it is important to assess, not only the amount of vision provided but also the quality of vision once they are implanted. The purpose of the present work was to compare the visual performance between two monofocal intraocular models: a standard model and a monofocal with enhanced intermediate vision lens.MethodsProspective, randomized, comparative study. Sixty adult subjects scheduled to undergo bilateral cataract surgery and IOL implantation were randomized to receive one of the two IOLs in both eyes at Miranza IOA, Madrid, Spain (group A: monofocal with enhanced intermediate vision lens and group B: standard monofocal lens). Monocular outcomes (right eyes) determined 1 and 3 months postoperatively were photopic corrected distance visual acuity (CDVA), uncorrected distance visual acuity (UDVA), perceived halo, corrected intermediate-distance contrast sensitivity, and higher-order aberrations. The impact of the new IOL in the postoperative management with autorefraction devices was also evaluated.ResultsNo differences were found in CDVA between the two groups. Significant differences were detected between the two lenses evaluated in both total HOA (p = 0.028) and internal HOA (p = 0.037). Contrast sensitivity and halometry results obtained at 1 month were similar across the two IOL groups.ConclusionIn patients undergoing cataract surgery, monofocal with enhanced intermediate vision IOL offered similar distance performance and contrast sensitivity along with perceived HOA and halos compared with the standard monofocal IOLs tested.

Purpose To evaluate the impact of residual astigmatism on the optical and visual performance of an enhanced-monofocal isofocal intraocular lens (EM Isopure, BVI medical, Belgium) compared to a monofocal one (Micropure, BVI medical, Belgium). Methods Laboratory investigation and prospective, comparative and randomized clinical study. Optical quality was assessed on an optical bench for 2.0, 3.0, and 4.5 mm pupils. The effect of residual astigmatism was investigated from through-focus images recorded with increasing amounts of regular positive astigmatism induced with a deformable mirror. To evaluate the impact of residual astigmatism, 28 eyes of 28 patients were randomly assigned to either group. Residual astigmatism was induced with positive and negative cylinder lenses at 90 and 180°. Visual acuity (VA) was measured at each step. Results The optical performance of both IOLs was quite similar for 2.0 and 3.0 mm pupils. For 4.5-mm pupil, the EM Isopure showed a significant reduction of its optical quality in comparison with the monofocal IOL. When visual performance was evaluated, no statistically significant differences were found for any power of induced astigmatism. More differences were found when positive induced astigmatism was compared within each group, and VA was better when the astigmatism was induced at 180° vs. 90°. The greatest differences were found for and induced positive astigmatism of + 1.50D ( p  = 0.009 for Isopure and p  = 0.023 for Micropure). Conclusions The tolerance to residual astigmatism of the EM Isopure lens is similar to that of a reference monofocal lens with pupils up to 3.5 mm.

PurposeTo compare clinical outcomes of bilateral implantation of hybrid multifocal intraocular lenses (IOLs) versus mix-and-match implantation of hybrid multifocal and extended-depth-of-focus (EDOF) versus mix-and-match implantation of hybrid multifocal and enhanced monofocal IOLs.MethodsPatients with bilateral age-related cataract were randomised in one of three groups: group 1, bilateral hybrid multifocal IOL; group 2, EDOF in the dominant eye, hybrid multifocal in the non-dominant eye; group 3, enhanced monofocal in the dominant eye, hybrid multifocal in the non-dominant eye. Assessments at 6 months postoperatively included monocular and binocular uncorrected distance visual acuity (UDVA), intermediate (UIVA) and near distance (UNVA) at 40 and 33 cm, defocus curves, contrast sensitivity (CS), reading speed and questionnaires on quality of vision and dysphotopsia.Results75 patients (25 per group) were enrolled. There were no statistically significant differences in binocular UDVA and UNVA between groups (p>0.05); binocular UIVA was better for group 1 and 2 versus group 3 (p=0.030). Binocular uncorrected defocus curve showed better performance for group 1 compared with group 3 from −2.00 to −3.50 D. Significantly higher reading speed was measured for Jaeger 1 font in group 1. There were no differences in CS between groups, but higher incidence of starbursts in group 1 and higher need for near spectacles in group 3.ConclusionBilateral hybrid multifocal IOL implantation resulted in better near vision, but higher rates of photic phenomena compared with the mix-and-match groups. Combinations of IOLs may allow surgeons to fine-tune for individual patient’s needs.

Background Treatment of pediatric cataract remains challenging because of the extremely high incidence of postoperative adverse events (AEs), especially the AEs related to the locations of secondary implanted intraocular lens (IOL). There are two common locations for secondary IOL implantation in pediatric aphakic eyes: ciliary sulcus or in-the-bag implantation. However, there are currently no large, prospective studies comparing complication rates and visual prognosis of in-the-bag versus ciliarysulcus secondary IOL implantation in pediatric patients. Whether or how much secondary in-the-bag IOL implantation benefits the pediatric patients more than sulcus implantation and deserves to be performed routinely by surgeons remains to be elucidated. Here, we describe the protocol of a randomized controlled trial (RCT) designed to evaluate the safety and efficacy of two approaches of IOL implantation in pediatric aphakia. Methods The study is a multicenter, single-blinded RCT with 10 years of follow-up. Overall, a minimum of 286 eyes (approximately 228 participants assuming 75% have two study eyes) will be recruited. This study will be carried out in four eye clinics across China. Consecutive eligible patients are randomized to undergo either secondary in-the-bag IOL implantation or secondary sulcus IOL implantation. Participants with two eyes eligible will receive the same treatment. The primary outcomes are IOL decentration and the incidence of glaucoma-related AEs. The secondary outcomes include the incidence of other AEs, IOL tilt, visual acuity, and ocular refractive power. Analysis of the primary and secondary outcomes is to be based on the intention-to-treat and per-protocol analysis. Statistical analyses will include the χ 2 test or Fisher’s exact test for the primary outcome, mixed model and generalized estimated equation (GEE) model for the secondary outcome, Kaplan–Meier survival curves for the cumulative probability of glaucoma-related AEs over time in each group. Discussion To the best of our knowledge, this study is the first RCT to evaluate the safety and efficacy of secondary IOL implantation in pediatric aphakia. The results will provide high-quality evidence for the clinical guidelines for the treatment of pediatric aphakia. Trial registration ClinicalTrials.gov NCT05136950. Registered on 1 November 2021.

Purpose: To establish and validate the accuracy of implantable collamer lens (ICL) vault size prediction formula based on preoperative biometric factors and lens parameters. Methods: This study included 300 patients (300 eyes) with Visian ICL V4c (STAAR Surgical) implantation. They were randomly divided into the formula establishment group and formula validation group. Anterior segment measurements, ICL V4c size and power, and vault 1 week postoperatively were collected from all patients. Multiple linear regression analysis was performed to establish the prediction formula. Mean absolute error (MAE), median absolute error (MedAE), root mean square error (RMSE), and Bland-Altman diagrams were used to evaluate the prediction formula. Results: Anterior chamber depth (ACD) had the greatest influence on vault 1 week after ICL V4c implantation, followed by ICL V4c size and angle-to-angle distance (ATA). The prediction formula was obtained according to the partial regression coefficient, which was vault (mm) = −1.279 + 0.291 × ACD (mm) + 0.210 × ICL V4c size (mm) – 0.144 × ATA (mm) (R2 = 0.661). In the formula validation group, the mean predictive vault, MAE, MedAE, and RMSE were 628.10, 135.09, 130.42, and 150.46 µm, respectively. The Bland-Altman diagram showed the predictive vault was in good agreement with the actual vault. Conclusions: A novel ICL V4c vault prediction formula was developed and shown to be an effective method for predicting the vault to reduce surgical complications. [J Refract Surg. 2023;39(5):332–339.]

In clinical practice, the effect of a high vault on corneal endothelial cells after implantable collamer lens (ICL) implantation remains unclear. Many clinicians theoretically assume that a high postoperative vault leads to rapid endothelial damage, but no study has yet proven this hypothesis. We conducted a paired-eye study to compare changes in corneal endothelial cell density (ECD) between high and low postoperative vault groups. This retrospective study included 150 eyes of 75 patients with bilateral postoperative vault levels differing by more than 200 μm after ICL implantation. Patients were followed up for 7 years with ECD measurements, and changes in ECD were assessed between 6 months and 7 years post-surgery. Over the 7-year follow-up period, the percentage of ECD loss was 15.04% and 14.45% in the high- and low-vault groups, respectively. The bilateral paired-eye comparison revealed a significant reduction in ECD in the high-vault group at 3, 5, and 7 years postoperatively (P-value < 0.001). In this paired-eye comparison of long-term observations, a higher vault was associated with greater ECD loss. Our study confirms that a high vault level may be an important risk factor for ECD loss following ICL implantation.

To compare the visual outcomes of bilateral implantation of two commercially available trifocal intraocular lenses (IOLs) (AcrySof IQ PanOptix IOL; Alcon Laboratories, Inc and AcrivaUD Trinova IOL; VSY Biotechnology). This comparative, investigator-initiated, single-center randomized trial was conducted by the Department of Ophthalmology of the Medipol Mega University Hospital in Istanbul, Turkey. Adult patients were randomized in a 1:1 ratio using a block randomization program to undergo cataract surgery and receive the implantation of either the PanOptix or Trinova IOL in both eyes. Outcome measures including binocular uncorrected and corrected visual acuities at distance, intermediate (66 cm), and near (40 cm), defocus curve, refractive outcomes, contrast sensitivity, glare and halos, and patient satisfaction were assessed at a minimum of 3 months following bilateral IOL implantation. A total of 71 patients (142 eyes) were included, with 35 patients (70 eyes) in the PanOptix IOL group and 36 patients (72 eyes) in the Trinova IOL group. At the 3-month follow-up examination, mean distance-corrected intermediate visual acuity (primary endpoint) was significantly better for the PanOptix IOL group (0.0 ± 0.09 logMAR) compared with the Trinova IOL group (0.01 ± 0.10 logMAR) ( = .0304). Mean logMAR uncorrected intermediate acuity (UIVA) and near (UNVA) visual acuity were also significantly better for the PanOptix IOL group (UIVA = 0.1 ± 0.10 logMAR; UNVA= 0.0 ± 0.09 logMAR) compared with the Trinova IOL group (UIVA = 0.2 ± 0.10 logMAR; UNVA = 0.2 ± 0.11 logMAR) (both < .001). There were no statistically significant differences in all other outcomes between groups. No adverse events were reported in both groups. These results suggest that the PanOptix IOL provides better intermediate and near visual outcomes compared to the Trinova IOL and represents a good choice for patients seeking to achieve spectacle independence. .

Objective To evaluate the clinical efficacy of a novel ophthalmic viscosurgical device-free method using an anterior chamber maintainer for intraocular collamer lens implantation in eyes with myopia. Methods Forty patients underwent bilateral intraocular collamer lens implantation, with one eye receiving the traditional implantation method using an ophthalmic viscosurgical device and the other eye undergoing the anterior chamber maintainer method. Preoperative and postoperative parameters, including uncorrected distance visual acuity, best-corrected distance visual acuity, spherical equivalent, intraocular pressure, aberrations, subjective visual quality, corneal endothelial cell density, operation time, and complications, were compared between and within the two groups. Results In the traditional group, 10% of eyes had intraocular pressure >22 mmHg at 2 h postoperatively, compared with 0% in the anterior chamber maintainer group (P < 0.001). The anterior chamber maintainer group showed better uncorrected and best-corrected distance visual acuity, spherical equivalent, total and low-order aberrations, and defocus at 1 day postoperatively (all P < 0.05), as well as shorter operation time (2.85 ± 0.30 vs. 4.37 ± 0.66 min, P < 0.001). No complications were observed except early intraocular pressure elevation in the traditional group. Conclusion The anterior chamber maintainer intraocular collamer lens implantation method provides faster visual recovery, a shorter operation time, and more stable intraocular pressure. It offers a convenient alternative to the traditional approach, avoiding ophthalmic viscosurgical device-related complications without introducing new ones.

ObjectivesTo compare the visual acuity, contrast sensitivity (CS), spectacle needs, photic phenomena, and quality of life parameters of patients bilaterally implanted with a low add multifocal (MIOL) or an extended depth of focus (EDOF) intraocular lens (IOL), both with intended mini-monovision.MethodsIn this prospective, randomized, comparative study, patients were randomized to receive either Tecnis +2.75 D (ZKB00) (MIOL Group, n = 15) or Tecnis Symfony (ZXR00) (EDOF Group, n = 14) for bilateral implantation with mini-monovision (−0.50 D). Binocular logMAR uncorrected visual acuities (UVA), monocular defocus curves, CS with CSV 1000-E, and Pelli-Robson Test (PRT), spectacle needs and quality of life parameters with NEI RQL-42 questionnaire were evaluated at postoperative 1, 3, and 6 months.ResultsResults of MIOL and EDOF Groups at postoperative month 6 are as follows: distance (6 m) UVA −0.03 ± 0.05 and −0.05 ± 0.06 (p = 0.938), intermediate (60 cm) UVA, 0.04 ± 0.08 and −0.03 ± 0.07 (p = 0.046); near (40 cm) UVA, 0.22 ± 0.08 and 0.15 ± 0.07 (p = 0.046); near spectacle needs, 26.7% and 14.3% (p > 0.05), respectively. Better visual acuity was achieved in the EDOF Group between the defocus range of −0.50 and −1.75 D (p < 0.05). No significant difference was found regarding photic phenomena and CS evaluated with CSV 1000-E between the two IOL groups at 6 months after surgery (otherwise there are differences at 1 and 3 months in favor of EDOF). However, EDOF Group performed better in mesopic CS evaluated with PRT (p < 0.05).ConclusionsWhen implanted with mini-monovision better binocular uncorrected visual performance at intermediate and near distances achieved with EDOF than low add MIOL.