PMID- 35297798
OWN - NLM
STAT- MEDLINE
DCOM- 20221004
LR  - 20221004
IS  - 1873-4502 (Electronic)
IS  - 0886-3350 (Linking)
VI  - 48
IP  - 10
DP  - 2022 Oct 1
TI  - Twelve-month clinical outcomes after implantation of a new, modular, anterior 
      shape-changing fluid optic intraocular lens.
PG  - 1134-1140
LID - 10.1097/j.jcrs.0000000000000935 [doi]
AB  - PURPOSE: To report the initial safety and effectiveness profile for an anterior 
      shape-changing, modular IOL, Juvene IOL (JIOL), for the treatment of aphakia and 
      presbyopia after removal of the natural crystalline lens due to cataract. 
      SETTING: 2 private practices in Monterrey and Tijuana, Mexico. DESIGN: 
      Exploratory prospective multicenter open-label noncomparative clinical trial. 
      METHODS: A convenience sample of patients aged 50 to 80 years with planned 
      cataract surgery was recruited to undergo unilateral or bilateral implantation 
      with the JIOL. Patients were required to complete an informed consent and be able 
      to dilate to at least 6.0 mm pharmacologically, be in good overall health, and 
      have no significant eye health history to qualify. Visual acuities, defocus 
      curves, and contrast sensitivity were measured for all patients 12 months 
      postoperatively. RESULTS: 51 of 58 eyes completed the 12-month visit. 
      Intraoperative complication rates were extremely low (n = 1; missed base lens 
      tab). The most frequent adverse events (AEs) were prolonged inflammation (N = 6) 
      and cystoid macular edema (N = 4); all AEs were resolved without sequelae by the 
      12-month visit. The mean monocular logMAR corrected distance visual acuity, 
      distance-corrected intermediate visual acuity, and distance-corrected near visual 
      acuity were 0.01, 0.08, and 0.24, respectively. Defocus testing showed visual 
      acuity > 20/40 from approximately +1.00 through -2.00 diopters. Binocular 
      implantation (n = 16) provided superior performance over monocular implantation. 
      CONCLUSIONS: The JIOL offers a new solution to treat presbyopia, providing clear 
      functional vision performance across a range of distances with an acceptable 
      initial safety profile.
CI  - Copyright (c) 2022 Published by Wolters Kluwer on behalf of ASCRS and ESCRS.
FAU - Garg, Sumit
AU  - Garg S
AUID- ORCID: 0000-0001-5081-0771
AD  - From the University of California Irvine, Irvine, California (Garg); LensGen, 
      Inc., Irvine, California (De Jesus, Fletcher, Casey); CODET Vision Institute, 
      Tijuana, Mexico (Chayet); Dr. Enrique Barragan Private Practice, Monterrey, 
      Mexico (Barragan).
FAU - De Jesus, Melinda T
AU  - De Jesus MT
AUID- ORCID: 0000-0001-9818-7691
FAU - Fletcher, Laura M
AU  - Fletcher LM
FAU - Chayet, Arturo
AU  - Chayet A
FAU - Barragan, Enrique
AU  - Barragan E
FAU - Casey, Patrick
AU  - Casey P
AUID- ORCID: 0000-0001-5670-2990
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PL  - United States
TA  - J Cataract Refract Surg
JT  - Journal of cataract and refractive surgery
JID - 8604171
SB  - IM
MH  - *Cataract/complications
MH  - Humans
MH  - Lens Implantation, Intraocular/adverse effects
MH  - *Lenses, Intraocular
MH  - *Phacoemulsification
MH  - *Presbyopia
MH  - Prospective Studies
MH  - Prosthesis Design
MH  - Pseudophakia
MH  - Vision, Binocular
EDAT- 2022/03/18 06:00
MHDA- 2022/10/05 06:00
CRDT- 2022/03/17 12:13
PHST- 2021/07/16 00:00 [received]
PHST- 2022/03/10 00:00 [accepted]
PHST- 2022/03/18 06:00 [pubmed]
PHST- 2022/10/05 06:00 [medline]
PHST- 2022/03/17 12:13 [entrez]
AID - 02158034-202210000-00007 [pii]
AID - 10.1097/j.jcrs.0000000000000935 [doi]
PST - ppublish
SO  - J Cataract Refract Surg. 2022 Oct 1;48(10):1134-1140. doi: 
      10.1097/j.jcrs.0000000000000935.