ArticleClinical ophthalmology (Auckland, N.Z.)2021
Effectiveness and Safety of the Clareon Monofocal Intraocular Lens: Outcomes from a 12-Month Single-Arm Clinical Study in a Large Sample.
Article in Clinical ophthalmology (Auckland, N.Z.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05697978 (Distance and Intermediate Visual Acuity in Patients With Implanted Monofocal Negative Aspheric Intraocular Lens), which is not on this map. Cited by 18 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Distance and Intermediate Visual Acuity in Patients With Implanted Monofocal Negative Aspheric Intraocular Lens
Who cites it
18 citing papers in PubMed, 34 citations in OpenAlex.
- Photic Phenomena and Quality of Vision Following Aspheric Toric Monofocal IOL with a Double C-Loop Haptic Design Implantation.Clinical ophthalmology (Auckland, N.Z.) · 2026Trial
- Outcomes of Bilateral Implantation of a New Aspheric Hydrophobic Non-Diffractive Extended Depth of Focus IOL with a Mini-Monovision Approach.Clinical ophthalmology (Auckland, N.Z.) · 2025Trial
- Twelve-Months Follow-Up Postmarket Study of a Hydrophobic Intraocular Lens Using a Preloaded Automated Injector in an Indian Population.Clinical ophthalmology (Auckland, N.Z.) · 2022Trial
- Non-Interventional Study to Evaluate the Effect of Non-Diffractive Extended Depth of Focus Intraocular Lens Centration and Tilt on Visual Performance.Clinical ophthalmology (Auckland, N.Z.) · 2026Article
- Long-Term Clarity of High-Water-Content Hydrophobic Acrylic Intraocular Lens: A 3-Year Randomized Comparison with a Hydrophobic Lens of Similar Material and Design.Ophthalmology and therapy · 2025Article
- Review
- Visual Performance After Bilateral Implantation of a New Enhanced Monofocal Hydrophobic Acrylic Intraocular Lens Targeted for Mini-Monovision.Life (Basel, Switzerland) · 2025Article
- Multicenter Retrospective Analysis of Intraoperative Aberrometer Measurements and Associated Visual Outcomes with a Monofocal Aspheric Intraocular Lens.Clinical ophthalmology (Auckland, N.Z.) · 2025Article
- Posterior Capsular Opacification and Glistening in Hydrophobic Monofocal Biaspheric Intraocular Lens Two Years After Implantation: A Case Control Study.Journal of ophthalmology · 2024Article
- Impact of Aspheric Monofocal Intraocular Lens Implantation on Uncorrected Intermediate Visual Acuity: a Combined Analysis.Clinical ophthalmology (Auckland, N.Z.) · 2024Article
- Evaluation of Intermediate Visual Outcomes in Eyes Implanted with Bilateral Advanced Monofocal Intraocular Lens Targeting for Mini-Monovision and Its Association with Age and Corneal Asphericity.Clinical ophthalmology (Auckland, N.Z.) · 2024Article
- The Clareon Vs AcrySof PanOptix Trifocal IOL: A Comparative Study of Patient Satisfaction and Visual Performance.Clinical ophthalmology (Auckland, N.Z.) · 2024Article
- Visual Outcomes and Patient Satisfaction with a Hydrophobic Acrylic Monofocal IOL Delivered Using a Manual System.Clinical ophthalmology (Auckland, N.Z.) · 2024Article
- Clinical Evaluation of a Hydrophobic Intraocular Lens Using a Preloaded Automated Injector in a Korean Population.Clinical ophthalmology (Auckland, N.Z.) · 2023Article
- Evaluation of Visual Outcomes and 3-Month Refractive Stability of a New Hydrophobic Acrylic Intraocular Lens.Clinical ophthalmology (Auckland, N.Z.) · 2023Article
- YAG Capsulotomy Rates in Patients Following Cataract Surgery and Implantation of New Hydrophobic Preloaded Intraocular Lens in an Australian Cohort: 3-Year Results.Clinical ophthalmology (Auckland, N.Z.) · 2023Article
- Comparison Between L-312 Hydrophobic-Hydrophilic Acrylate and US-860 UV Hydrophilic Acrylate IOL Opacification Characteristic.Frontiers in medicine · 2022Article
- Rotational Stability of the Clareon Monofocal Aspheric Hydrophobic Acrylic Intraocular Lens 6 Months After Implantation.Clinical ophthalmology (Auckland, N.Z.) · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThis study assessed effectiveness and safety of the novel Clareon intraocular lens (IOL; model SY60CL; Alcon Vision LLC). PATIENTS AND
methodsThis was a prospective, single-arm, unmasked clinical trial at 16 investigative clinical sites in the United States. Included were adults ≥22 years who required cataract extraction by phacoemulsification. Following phacoemulsification, 350 subjects received SY60CL IOL unilaterally; 342 completed the study. Monocular best corrected distance visual acuity (CDVA) and uncorrected distance visual acuity (UDVA) were evaluated. The primary effectiveness endpoint was the percentage of subjects with CDVA ≤0.3 logMAR at month 12. Safety was assessed by monitoring adverse events (AEs). Visual acuity and safety outcomes were compared with historical safety and performance endpoint (SPE) rates.
resultsAt 12 months post-implantation, 99.7% of subjects receiving the SY60CL IOL achieved monocular CDVA ≤0.3 logMAR (primary effectiveness endpoint; 1-sided 95% upper confidence limit >SPE rate); 99.7% and 86.8% of subjects achieved monocular CDVA of ≤0.34 (20/40 Snellen or better) and ≤0.04 logMAR (20/20 Snellen or better), respectively. At 12 months, >95% of subjects achieved mean monocular UDVA ≤0.3 logMAR; 97.1% and 57.6% of subjects achieved monocular CDVA of ≤0.34 and ≤0.04 logMAR, respectively. Mean monocular CDVA and UDVA were -0.05 and 0.04 logMAR, respectively. AEs were within SPE limits. The most common nonserious ocular AE was posterior capsule opacification (5.4%). Serious AEs were <1%, and no serious ocular AEs were assessed as related to the device. There were no observations for IOL glistenings at 12 months.
conclusionResults of this study supported effectiveness and safety of the SY60CL IOL. Visual acuity outcomes with the SY60CL IOL exceeded the SPE rates for monocular CDVA and AEs were within the limit of historic SPE rates. (Model number SY60WF is the Clareon lens approved by the FDA.).
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.