Dataset Information

Three-year multinational clinical study on an aspheric hydrophobic acrylic intraocular lens.

ABSTRACT:

Purpose

To present the results of a study investigating the 3-year effectiveness and safety of the Clareon single-piece intraocular lens (IOL).

Setting

19 multinational sites.

Design

Prospective multicenter single-arm study.

Methods

Patients were bilaterally implanted with Clareon IOLs. Assessments included uncorrected distance visual acuity, corrected distance visual acuity (CDVA), manifest refraction, tilt, decentration, applanation tonometry, and fundus examination, including glistenings and posterior capsule opacification (PCO) evaluation. The primary outcomes for effectiveness and safety were evaluated at 1 year and compared with ISO historical safety and performance endpoint (SPE) rates. Patients were followed for up to 3 years after implantation.

Results

424 eyes of 215 patients were implanted (n = 215 first eye, n = 209 second eye), and 183 patients completed the trial at 3 years (with 364 binocular and 1 monocular patient). At 1 year, the cumulative and persistent adverse event rates were below SPE targets, and 99.5% of eyes achieved a monocular CDVA of ≤0.3 logMAR (vs the SPE target of 92.5%). At 3 years, the mean monocular CDVA was -0.032, with 93.4% (341/365) of eyes achieving a CDVA of 0.1 logMAR or better, 100% of eyes presented with grade 0 glistenings ≤25 MV/mm 2 , and 92.9% of eyes (394/424) had either no PCO or clinically nonsignificant PCO.

Conclusions

This study supports the long-term safety and effectiveness of the Clareon IOL. The visual outcomes were excellent and stable over the 3-year study period, PCO rates were very low, and 100% of IOLs had grade 0 glistenings.

SUBMITTER: Nuijts RMMA

PROVIDER: S-EPMC10284131 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature

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Publications

Three-year multinational clinical study on an aspheric hydrophobic acrylic intraocular lens.

Nuijts Rudy M M A RMMA Bhatt Uday U Nanavaty Mayank A MA Roberts Timothy V TV Peterson Rachael R Teus Miguel A MA

Journal of cataract and refractive surgery 20230222 7

<h4>Purpose</h4>To present the results of a study investigating the 3-year effectiveness and safety of the Clareon single-piece intraocular lens (IOL).<h4>Setting</h4>19 multinational sites.<h4>Design</h4>Prospective multicenter single-arm study.<h4>Methods</h4>Patients were bilaterally implanted with Clareon IOLs. Assessments included uncorrected distance visual acuity, corrected distance visual acuity (CDVA), manifest refraction, tilt, decentration, applanation tonometry, and fundus examinatio ...[more]

PMID: 36848238

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Project description:PurposeTo assess refractive and visual outcomes post-cataract surgery with bilateral implantation of a bi-aspheric diffractive trifocal intraocular lens (IOL).MethodsA total of 24 patients who underwent bilateral implantation with the Asqelio Trifocal IOL TFLIO130C were evaluated at the 6 months postoperative mark. Key outcome measures included refractive error, photopic monocular and binocular uncorrected and corrected distance visual acuity (UDVA, CDVA), uncorrected and corrected intermediate visual acuity (UIVA, CDIVA) at 60 cm, and uncorrected and corrected near visual acuity (UNVA, CDNVA) at 40 cm. Additionally, monocular and binocular CDNVA were assessed under mesopic conditions. Monocular and binocular defocus curves, and binocular contrast sensitivity under photopic and mesopic conditions, with and without glare, were measured. Catquest-9SF and visual symptoms questionnaires were also administered.ResultsPostoperative average values of binocular logMAR photopic CDVA, photopic CDIVA, photopic CDNVA and mesopic CDNVA were -0.01±0.06, 0.03±0.09, 0.02±0.05 and 0.19±0.13, respectively. About 100% of patients showed cumulative CDVA and CDNVA ≥20/25, and CDIVA ≥20/32. The average absolute depth-of-focus was about 4.50D. The average postoperative spherical equivalent was 0.05±0.30D and 100% and 93.75% eyes were within ±1.00D and ±0.50D, respectively. Contrast sensitivity was either within or above normal levels under both photopic and mesopic conditions, both with and without glare, except for 12 cpd under mesopic conditions with glare where the mean falls just below the normal range. Questionnaires revealed that 87.5% of patients were either satisfied or very satisfied with their vision after the surgery, and higher percentages for no difficulty in performing different activities, ranging from 70.83% to 95.83%, were reported.ConclusionThis study demonstrates that the bi-aspheric diffractive trifocal IOL yields very good visual performance across distances, fostering high satisfaction levels and minimal difficulties in daily activities.

Project description:PurposeTo analyze internal spherical aberration in pseudophakic eyes that underwent aspheric intraocular lens (IOL) implantation, and to investigate the relationships between biometric data and the effectiveness of aspheric IOL implantation.MethodsThis retrospective study included 40 eyes of 40 patients who underwent implantation of an IOL having a negative spherical aberration of -0.20 μm (CT ASPHINA 509M; Carl Zeiss Meditec Inc., Germany). The IOLMaster (version 5.0; Carl Zeiss AG, Germany) was used for preoperative biometric measurements (axial length, anterior chamber depth, central corneal power) and the measurement of postoperative anterior chamber depth. The spherical aberrations were measured preoperatively and 3 months postoperatively using the iTrace (Tracey Technologies, Houston, TX, USA) at a pupil diameter of 5.0 mm. We investigated the relationships between preoperative biometric data and postoperative internal spherical aberration, and compared biometric measurements between 2 subgroups stratified according to internal spherical aberration (spherical aberration ≤ -0.06 μm vs. spherical aberration > -0.06 μm).ResultsThe mean postoperative internal spherical aberration was -0.087 ± 0.063 μm. Preoperative axial length and residual total spherical aberration showed statistically significant correlations with internal spherical aberration (p = 0.041, 0.002). Preoperative axial length, postoperative anterior chamber depth, IOL power, and residual spherical aberration showed significant differences between the 2 subgroups stratified according to internal spherical aberration (p = 0.020, 0.029, 0.048, 0.041 respectively).ConclusionThe corrective effect of an aspheric IOL is influenced by preoperative axial length and postoperative anterior chamber depth. Not only the amount of negative spherical aberration on the IOL surface but also the preoperative axial length should be considered to optimize spherical aberration after aspheric IOL implantation.

Dataset Information

Three-year multinational clinical study on an aspheric hydrophobic acrylic intraocular lens.

Purpose

Setting

Design

Methods

Results

Conclusions

Publications

Three-year multinational clinical study on an aspheric hydrophobic acrylic intraocular lens.

Similar Datasets

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