PMID- 33907378
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220422
IS  - 1177-5467 (Print)
IS  - 1177-5483 (Electronic)
IS  - 1177-5467 (Linking)
VI  - 15
DP  - 2021
TI  - Effectiveness and Safety of the Clareon Monofocal Intraocular Lens: Outcomes from 
      a 12-Month Single-Arm Clinical Study in a Large Sample.
PG  - 1647-1657
LID - 10.2147/OPTH.S295008 [doi]
AB  - PURPOSE: This study assessed effectiveness and safety of the novel Clareon 
      intraocular lens (IOL; model SY60CL; Alcon Vision LLC). PATIENTS AND METHODS: 
      This 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. RESULTS: At 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. CONCLUSION: Results 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.).
CI  - (c) 2021 Lehmann et al.
FAU - Lehmann, Robert
AU  - Lehmann R
AUID- ORCID: 0000-0002-6605-8307
AD  - Lehmann Eye Center, Nacogdoches, TX, USA.
FAU - Maxwell, Andrew
AU  - Maxwell A
AD  - California Eye Institute, Fresno, CA, USA.
FAU - Lubeck, David M
AU  - Lubeck DM
AD  - Arbor Centers for EyeCare, Homewood, IL, USA.
FAU - Fong, Raymond
AU  - Fong R
AD  - Manhattan Eye, Ear, and Throat Hospital, Lenox Hill Hospital, New York, NY, USA.
FAU - Walters, Thomas R
AU  - Walters TR
AUID- ORCID: 0000-0001-6092-9733
AD  - Texan Eye, Austin, TX, USA.
FAU - Fakadej, Anna
AU  - Fakadej A
AD  - Carolina Eye Associates, PA, Southern Pines, NC, USA.
LA  - eng
PT  - Journal Article
DEP - 20210420
PL  - New Zealand
TA  - Clin Ophthalmol
JT  - Clinical ophthalmology (Auckland, N.Z.)
JID - 101321512
PMC - PMC8068507
OTO - NOTNLM
OT  - cystoid macular edema
OT  - dysphotopsia
OT  - glistenings
OT  - posterior capsule opacification
OT  - visual acuity
COIS- RL, AM, and DML are Alcon consultants. AF is a researcher and a speaker for 
      Alcon. Dr David M Lubeck reports he is a consultant for NovaEye, 
      consultant/investigator for Glaukos, outside the submitted work. Dr Andrew 
      Maxwell reports personal fees from Alcon, outside the submitted work. Dr Robert 
      Lehmann reports grants from Alcon, during the conduct of the study. The authors 
      report no other conflicts of interest in this work.
EDAT- 2021/04/29 06:00
MHDA- 2021/04/29 06:01
PMCR- 2021/04/20
CRDT- 2021/04/28 06:17
PHST- 2020/12/01 00:00 [received]
PHST- 2021/03/30 00:00 [accepted]
PHST- 2021/04/28 06:17 [entrez]
PHST- 2021/04/29 06:00 [pubmed]
PHST- 2021/04/29 06:01 [medline]
PHST- 2021/04/20 00:00 [pmc-release]
AID - 295008 [pii]
AID - 10.2147/OPTH.S295008 [doi]
PST - epublish
SO  - Clin Ophthalmol. 2021 Apr 20;15:1647-1657. doi: 10.2147/OPTH.S295008. eCollection 
      2021.