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Journal of Cataract and Refractive... Jun 2024To evaluate subjective and objective outcomes after combined implantation of an extended depth-of-focus (EDOF) intraocular lens (IOL) and a combined technology...
PURPOSE
To evaluate subjective and objective outcomes after combined implantation of an extended depth-of-focus (EDOF) intraocular lens (IOL) and a combined technology multifocal lens (CT-IOL).
SETTING
2 clinical practices (Carolina Eyecare Physicians, Center For Sight) in the United States.
DESIGN
Prospective, unmasked, multicenter, nonrandomized bilateral eye study.
METHODS
Patients interested in reducing their dependence on spectacles were implanted with an EDOF IOL in the dominant eye and a CT-IOL in the nondominant eye. Refractive and visual acuity (VA) data at various distances (4 m, 66 cm, 40 cm, and 33 cm) were collected 3 months postsurgery, along with the distance-corrected binocular defocus curve and responses to questionnaires related to spectacle independence, visual disturbances, and overall visual function.
RESULTS
Data from 37 participants were analyzed. The distance-corrected binocular defocus curve showed a mean VA better than 0.1 logMAR (20/25) at all vergences from +1.00 to -2.50 diopters (D). 36 participants (97%) had an uncorrected binocular VA of 0.3 logMAR or better, at all test distances. 70% of participants (26/37) reported never wearing spectacles at any distance, and 84% (31/37) were "completely" or "mostly" satisfied with their overall vision after surgery. Halos were the disturbance reported most frequently and reported as most bothersome, with difficulty driving at night the most common visual function issue. Difficulty reading was the next most reported issue. Overall eyesight was rated as "excellent" or "good" by 92% (34/37) of participants.
CONCLUSIONS
This combined EDOF/CT-IOL approach was well-tolerated by participants and provided some potential benefits relative to bilateral implantation of either lens.
Topics: Humans; Prospective Studies; Visual Acuity; Lens Implantation, Intraocular; Presbyopia; Vision, Binocular; Male; Female; Middle Aged; Aged; Refraction, Ocular; Phacoemulsification; Pseudophakia; Patient Satisfaction; Lenses, Intraocular; Surveys and Questionnaires; Multifocal Intraocular Lenses; Dominance, Ocular; Depth Perception; Prosthesis Design
PubMed: 38305420
DOI: 10.1097/j.jcrs.0000000000001412 -
Indian Journal of Ophthalmology Feb 2024To assess the photic phenomena (PP) and positive dysphotopsia in candidates for presbyopia or cataract surgery and to evaluate their relationship with cataract grading...
PURPOSE
To assess the photic phenomena (PP) and positive dysphotopsia in candidates for presbyopia or cataract surgery and to evaluate their relationship with cataract grading systems.
DESIGN
Retrospective observational.
METHODS
Monocular data for 82 subjects measured during the preoperative screening were retrospectively retrieved from our database. The evaluated variables consisted of two methods for PP measurement: light distortion index (LDI) and parameters obtained from a simulator, both of which were combined with subjective bother related to PP. The cutoff for LDI that better predicted patients passing from slightly to moderately bothersome was estimated. The relationships between LDI and the following objective cataract grading methods were also assessed: objective scatter index (OSI), dysfunctional lens index (DLI), and Pentacam Nucleus Staging (PNS).
RESULTS
LDI was the best method for measuring PP, which showed a significant correlation with the bothersome question (rho = 0.34, P = 0.002) and also with OSI (rho = 0.67, P < 0.0005), DLI (rho = -0.29, P = 0.007), and PNS (rho = 0.48, P < 0.0005). The number/percentage of patients who found it bothersome was as follows: "Not at all" (18/22%), "Slightly" (41/50%), "Moderately" (15/18.3%), and "Very" (8/9.7%). The cutoff value that predicted the transition from slightly to moderately bothersome was ≥15.20% according to LDI, which could be estimated with the following values for grading: ≥2.8 for OSI, ≤7.6 for DLI, and ≥2 for PNS.
CONCLUSIONS
Patients reporting moderately or higher bothersome levels in the preoperative period and with LDI <15.20%, <2.8 for OSI, >7.6 for DLI, and <2 for PNS might deserve special attention in the multifocal intraocular lens selection.
Topics: Humans; Multifocal Intraocular Lenses; Visual Acuity; Retrospective Studies; Lens Implantation, Intraocular; Prospective Studies; Cataract; Vision Disorders; Lenses, Intraocular; Phacoemulsification
PubMed: 38271416
DOI: 10.4103/IJO.IJO_1038_23 -
Journal of Current Ophthalmology 2023To investigate the outcomes of unilateral Supracor treatment to enhance near vision while maintaining good distance vision in hyperopic eyes.
PURPOSE
To investigate the outcomes of unilateral Supracor treatment to enhance near vision while maintaining good distance vision in hyperopic eyes.
METHODS
This prospective interventional study includes consecutive hyperopic patients with presbyopia. All eyes underwent femtosecond laser-assisted keratomileusis treatment for hyperopia with an additional Supracor multifocal treatment algorithm in nondominant eyes. Monocular and binocular uncorrected and spectacle-corrected distance visual acuity (UCDVA and SCDVA), monocular and binocular uncorrected near visual acuity (UNVA), and distance-corrected near visual acuity at 40 cm and high-order aberration changes and complications were evaluated for 6 months.
RESULTS
Sixty-four patients with a mean age of 51.91 ± 3.64 were enrolled. After 6-month follow-up, the mean binocular UCDVA and UNVA were 0.03 ± 0.05 and 0.04 ± 0.06 logMAR, respectively. UCDVA (logMAR) of nondominant and dominant eyes was 0.30 ± 0.18 and 0.03 ± 0.05, respectively. Preoperative and postoperative mean ± standard deviation manifest refraction spherical equivalent was +1.84 ± 0.75 and -0.48 ± 0.57, respectively, in nondominant eyes and +1.77 ± 0.69 and +0.12 ± 0.33, respectively, in dominant eyes. No complications were observed.
CONCLUSION
Supracor procedure in nondominant eyes may improve functional near, intermediate, and distance vision without significant photic phenomena in presbyopic patients with low and moderate hyperopia.
PubMed: 38250484
DOI: 10.4103/joco.joco_2_23 -
Comparative Analysis of the Clinical Outcomes of Two Toric Presbyopia-Correcting Intraocular Lenses.Ophthalmology and Therapy Mar 2024To evaluate and compare the clinical outcomes of two toric presbyopia-correcting intraocular lenses (IOLs).
INTRODUCTION
To evaluate and compare the clinical outcomes of two toric presbyopia-correcting intraocular lenses (IOLs).
METHODS
Non-randomized prospective comparative study including 86 eyes of 51 patients (age 43-83 years) that underwent cataract surgery with implantation of one of the following two IOLs: TECNIS Toric Synergy (Johnson & Johnson Vision) (Synergy group) or AT LISA tri toric 939MP (Carl Zeiss Meditec) (ATLISA group). Visual and refractive outcomes were evaluated during a 6-month follow-up.
RESULTS
At 6 months after surgery, all eyes achieved uncorrected distance visual acuity 20/25 or better in both groups, whereas 96.2% and 100% of eyes achieved uncorrected near visual acuity (UNVA) 20/25 or better in the ATLISA and Synergy groups, respectively. All eyes achieved postoperative mesopic UNVA 20/30 or better in both IOL groups; 96.2% and 100% of eyes had a manifest cylinder ≤ 0.50 D at 6 months in ATLISA and Synergy groups, respectively. Mean magnitude of error was 0.04 ± 0.20 and - 0.04 ± 0.09 D in ATLISA and Synergy groups, respectively (p = 0.05). In the defocus curve, significant differences were found between IOL groups for most of distance-corrected visual acuities, except those corresponding to defocus of 0 D (p = 0.268) and - 1 D (p = 0.361).
CONCLUSIONS
The two toric presbyopia-correcting IOLs evaluated provide an efficacious astigmatic correction combined with a successful distance, intermediate and near visual rehabilitation. The visual performance seems to be better for most visual demands with the TECNIS Toric Synergy IOL, especially for distances closer than 40 cm.
PubMed: 38240999
DOI: 10.1007/s40123-023-00878-8 -
Frontiers in Public Health 2023The role of ophthalmologists is defined by tasks requiring visual effort, emphasizing the importance of examining their condition within the realm of occupational visual...
INTRODUCTION
The role of ophthalmologists is defined by tasks requiring visual effort, emphasizing the importance of examining their condition within the realm of occupational visual health. Our goal was to explore the occurrence of asthenopia among Chinese ophthalmologists and identify contributing factors through the use of a reliable and validated survey instrument.
METHODS
A national cross-sectional online survey was carried out in June 2017, involving 6,220 practicing ophthalmologists in China. Utilizing an 11-item Asthenopia Survey Questionnaire with established reliability and validity. Prevalence rates of asthenopia among subgroups categorized by age, gender, hospital classification, physician level, daily near vision activity duration, sleep duration, sleep quality, presbyopia status, and history of eye surgery were determined using the independent -test, chi-square test and bonferroni test. Multiple logistic regression analysis was employed to pinpoint independent factors linked to asthenopia.
RESULTS
Out of the 5,009 ophthalmologists who completed the survey, a 40.7% prevalence of asthenopia was identified. Multivariate analysis revealed that good sleep quality (OR: 0.24, 95%CI: 0.20-0.30), moderate sleep quality (OR: 0.47, 95%CI: 0.38-0.59), engaging in daily near vision activities for less than 7 h (OR: 0.76, 95%CI: 0.68-0.86), having daily sleep duration exceeding 7 h (OR: 0.87, 95%CI: 0.77-0.98), and working in tertiary hospitals (OR: 0.88, 95%CI: 0.78-0.99) were protective factors against asthenopia. Conversely, presbyopia was identified as a risk factor (OR: 1.33, 95%CI: 1.04-1.70). All calculated values were below 0.05. Age, gender, physician level, and eye surgery history were not related factors.
CONCLUSION
Asthenopia is prevalent among Chinese ophthalmologists, with employment in tertiary hospitals providing a protective effect and presbyopia is a risk factor. Preventive strategies include improving sleep quality, restricting daily near vision activity to under 7 h, and extending daily sleep duration to over 7 h. Further investigation is needed to explore the protective implications of working in tertiary hospitals.
Topics: Humans; Asthenopia; Presbyopia; Cross-Sectional Studies; Prevalence; Ophthalmologists; Reproducibility of Results; China
PubMed: 38222083
DOI: 10.3389/fpubh.2023.1290811 -
Contact Lens & Anterior Eye : the... Apr 2024The current multi-study analysis combined data from three studies to quantify the relationship between the initial reaction to soft multifocal contact lens (MFCL) design...
PURPOSE
The current multi-study analysis combined data from three studies to quantify the relationship between the initial reaction to soft multifocal contact lens (MFCL) design types at dispensing and evaluate the predictability of overall vision satisfaction (OVS) and intention to purchase (ITP) after 1 week of wear.
METHOD
Three prospective studies tested MFCLs over 1-week of wear following the same protocol, using a range of potentially predictive ratings at dispensing, and both OVS and ITP at 1-week as an indicator acceptance level. In each study, two of MyDay® multifocal, clariti® 1 day multifocal, Biofinity® multifocal (worn as a daily disposable lens) or 1 DAY ACUVUE® MOIST MULTIFOCAL were dispensed for 1-week of daily wear. OVS was recorded on a 100-point VAS and ITP on a 5-point LIKERT scale. Fourteen possible predictors were entered in the statistical model, and predictability was assessed using Chi-square Automatic Interaction Detector (CHAID) statistical test.
RESULTS
A total of 210 participants (152 female & 58 male; 53.9 ± 6.5 years, range 41-71 years), representing 420 MFCL fits, equally distributed between emergent n = 65, established n = 70 and advanced n = 75 presbyopes, completed the studies. OVS on dispensing was the predictor of both OVS (p < 0.001) and ITP (p < 0.001) at 1-week. For OVS predictability, 70.8 % with OVS at dispensing > 91 points reported good OVS at 1-week and 73.4 % with OVS on dispensing ≤ 80 points reported poor OVS at 1-week. For ITP predictability, 74.6 % with OVS at dispensing > 94 points reported a positive ITP at 1-week and 65.9 % with OVS on dispensing ≤ 63 points reported negative ITP at 1-week.
CONCLUSION
Overall vision satisfaction at the time of dispensing MFCLs is a powerful indicator of both OVS and ITP after 1-week of wear. Initial patient subjective assessments provide a clinically useful indicator of the likeliness of success.
Topics: Humans; Male; Female; Visual Acuity; Prospective Studies; Vision, Ocular; Contact Lenses, Hydrophilic; Presbyopia
PubMed: 38216392
DOI: 10.1016/j.clae.2023.102105 -
Clinical Therapeutics Feb 2024This study was undertaken to evaluate the safety and efficacy of CSF-1 (0.4% pilocarpine hydrochloride ophthalmic solution) for use in individuals with presbyopia. (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
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.
METHODS
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.
FINDINGS
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.
IMPLICATIONS
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).
Topics: Female; Humans; Middle Aged; Lens Implantation, Intraocular; Lenses, Intraocular; Macrophage Colony-Stimulating Factor; Ophthalmic Solutions; Pilocarpine; Presbyopia
PubMed: 38216351
DOI: 10.1016/j.clinthera.2023.12.005 -
Journal of Refractive Surgery... Jan 2024
PubMed: 38190569
DOI: 10.3928/1081597X-20231205-06 -
Journal of Refractive Surgery... Jan 2024To determine the visual outcomes and safety 12 months after implantation of the Presbia Flexivue Microlens refractive corneal inlay. (Clinical Trial)
Clinical Trial
PURPOSE
To determine the visual outcomes and safety 12 months after implantation of the Presbia Flexivue Microlens refractive corneal inlay.
METHODS
In this prospective, non-randomized trial, 22 patients with a mean age of 52.54 ± 2.86 years were implanted with the Flexivue Microlens refractive corneal inlay in the non-dominant eye at the Department of Ophthalmology, Goethe University, Frankfurt, Germany. Corrected near, intermediate, and distance (CNVA, CIVA, and CDVA) visual acuity and uncorrected near, intermediate, and distance (UNVA, UIVA, and UDVA) visual acuity, manifest refraction, subjective quality of vision, endothelial cell count, and contrast sensitivity were measured 1 day, 1 week, and 1, 3, 6, and 12 months postoperatively.
RESULTS
For binocular CDVA, no patient lost two or more lines and 30% lost only one line at the 12-month visit. In the eye that had surgery, 85% of the patients lost two or more lines of UDVA, which was statistically significant. Sixty-five percent of the patients gained one or more lines in binocular UIVA, and 80% achieved 20/40 or better in DCIVA. UNVA showed a statistically significant improvement, with 90% of the patients achieving 20/40 or better 12 months after implantation. A total of 85% gained two or more lines in binocular UNVA.
CONCLUSIONS
This refractive corneal inlay showed an improvement in binocular UNVA, UIVA, CNVA, and CIVA, whereas binocular CDVA and UDVA were not statistically affected. .
Topics: Humans; Middle Aged; Presbyopia; Prospective Studies; Refraction, Ocular; Vision Tests; Visual Acuity
PubMed: 38190559
DOI: 10.3928/1081597X-20231204-02 -
Optics Express Jan 2024What we believe to be a new type of transparent photon sieve is presented with application for presbyopia correction. Inspired by blazed gratings, we propose to design...
What we believe to be a new type of transparent photon sieve is presented with application for presbyopia correction. Inspired by blazed gratings, we propose to design an intracorneal implant with slanted holes. The slopes introduce a new degree of freedom, breaking the symmetry of energy distribution along the optical axis and allowing to balance the energy between near and far vision. This new implant design is presented together with the simulation, manufacturing and validation methods. The first experimental results obtained with an implant manufactured in a biocompatible material are presented confirming the potential of the approach.
PubMed: 38175070
DOI: 10.1364/OE.509300