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result(s) for
"Lens Implantation, Intraocular - methods"
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Visual and optical quality of enhanced intermediate monofocal versus standard monofocal intraocular lens
2022
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.
Journal Article
Efficacy and Safety of CSF-1 (0.4% Pilocarpine Hydrochloride) in Presbyopia: Pooled Results of the NEAR Phase 3 Randomized, Clinical Trials
2024
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).
Journal Article
Tolerance to residual astigmatism of an isofocal intraocular lens
2024
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.
Journal Article
Comparison of clinical outcomes between different combinations of hybrid multifocal, extended-depth-of-focus and enhanced monofocal intraocular lenses
2025
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.
Journal Article
Prediction of Implantable Collamer Lens Vault Based on Preoperative Biometric Factors and Lens Parameters
2023
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.]
Journal Article
Comparison of Visual Outcomes of Two Trifocal IOLs
2023
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.
.
Journal Article
Clinical outcomes with a low add multifocal and an extended depth of focus intraocular lenses both implanted with mini-monovision
by
Sevik, Mehmet Orkun
,
Toker, Ebru
,
Akkaya Turhan, Semra
in
Acuity
,
Binocular vision
,
Intraocular lenses
2022
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.
Journal Article
Vault of the phakic intraocular lens during vertical and horizontal fixation within patient comparison
2025
This study aimed to compare the postoperative vault and preoperative predictions between vertical and horizontal fixation of implantable collamer lenses (ICLs). In this prospective case series, 63 patients (126 eyes) who underwent bilateral ICL insertion for myopia were randomly assigned to either horizontal or vertical fixation for each eye. An additional control group consisted of 63 patients receiving bilateral horizontal non-toric ICL fixation. Biometric measurements, including anterior chamber depth (ACD) and vault, were obtained using anterior-segment three-dimensional optical coherence tomography preoperatively and at 2 h, 1 day, 1 week, and 1 month postoperatively. ACD values remained stable and similar between both groups (
P
> 0.05). However, vault values were consistently lower in the vertical group than in the horizontal group at all time points (
P
< 0.001). The vault difference between preoperative predictions and actual measurements was significantly larger in the vertical group compared to the horizontal group (
P
< 0.001). The intergroup vault difference was significantly larger than the left–right eye difference in the control group (
P
< 0.001). Vertical ICL fixation reduced the vault by approximately 150 μm compared to horizontal fixation, a deviation from preoperative predictions, which should be considered when determining ICL size.
Journal Article
Evaluation of Perception of Photic Phenomena Through Diffractive Multifocal Intraocular Lens Designs by Its Virtual Implantation
2025
Purpose
To analyze the difference in objective and subjective photic phenomena following virtual implantation of three different presbyopia-correcting diffractive intraocular lens (IOL) designs.
Methods
The study was conducted at JENVIS Research Germany. A prospective cross-over and double-masked trial design was used. Seventy-four healthy individuals without cataract (age: 18 to 50 years) were enrolled. All participants assessed photic phenomena with three diffractive IOL designs by virtual implantation using the VirtIOL device (10Lens S.L.U), which allows participants to view through the IOL imaged at the iris plane as if it were implanted: IOL A (Tecnis Synergy ZFR00V; J&J Vision), IOL B (AcrySof IQ PanOptix TFNT00; Alcon Laboratories, Inc), and IOL C (AT ELANA 841P; Carl Zeiss Meditec). The size of the starburst and annular light pattern was measured in degrees, and participants were asked about their preference in terms of quality of night vision when comparing by pairs the IOLs.
Results
The starburst pattern size was significantly larger with IOL A (5.54 ± 0.62º) compared to the IOLs B (3.82 ± 0.90º, P < .001) and C (3.65 ± 0.57º, P < .001). However, there were no significant differences between IOLs B and C (P = .078). Regarding the induced annular light pattern, no significant differences were found between IOLs (P > .05). In a pairwise short-term comparison of the IOLs using a simulated night scene with a glare source, participant preference was in favor of IOL C (P < .001).
Conclusions
IOL A had objectively a significantly larger starburst pattern than the other two. In a short-term comparison, the new trifocal IOL C was significantly preferred in a night driving scene.
Journal Article
Extended Depth of Focus Versus Monofocal IOLs: Objective and Subjective Visual Outcomes
2020
To evaluate and compare the objective and subjective outcomes between bilateral implantation of the extended depth of focus (EDOF) Mini Well intraocular lens (IOL) and the aspheric monofocal Mini-4-Ready IOL (both SIFI S.p.A., Catania, Italy).
This prospective comparative study included 25 patients (50 eyes) bilaterally implanted with an EDOF Mini Well IOL (EDOF group) and 25 patients (50 eyes) bilaterally implanted with a Mini-4-Ready IOL (monofocal group). Three-month follow-up data included corrected and uncorrected distance visual acuity at 4 m and 80, 67, and 40 cm. Defocus curves, subjective and objective contrast sensitivity, and objective optical quality (modulation transfer function cutoff and Strehl ratio calculated with Optical Quality Analysis System [OQAS]; Visiometrics SL, Terrassa, Spain), halometry, and reading performance were measured. Subjective visual quality was evaluated based on National Eye Institute Refractive Error Quality of Life Instrument 42 (NEI RQL-42) scores.
Postoperative uncorrected and corrected monocular and binocular intermediate and near visual acuity was significantly better in the EDOF group (P < .001). No differences were observed for distance visual acuity (P ⩾ .312). Defocus curve outcomes for myopic values were better in the EDOF group (P < .001). No significant differences were found in hyperopic (obtained in steps of +0.50 diopters [D] from emmetropia to 1.50 D) values (P ⩾ .095), contrast sensitivity curves (P ⩾ .087), or OQAS outcomes (P ⩾ .138). Halometric values were significantly better in the monofocal group (P < .05). There was a correlation between mean keratometry values and intermediate/near visual acuity. Significantly better NEI RQL-42 subscale scores for near vision, far vision, activity limitations, glare, dependence on correction, and suboptimal correction were noted in the EDOF group (P < .05).
Intermediate and near visual acuity was better after EDOF IOL than after aspheric monofocal IOL implantation while maintaining similar levels of visual quality, except for halo perception. [J Refract Surg. 2020;36(4):214-222.].
Journal Article