PMID- 35968054
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220816
IS  - 1177-5467 (Print)
IS  - 1177-5483 (Electronic)
IS  - 1177-5467 (Linking)
VI  - 16
DP  - 2022
TI  - Clinical Performance and Surgeon Acceptability of a New Dual Mode 
      Phacoemulsification System.
PG  - 2441-2451
LID - 10.2147/OPTH.S363061 [doi]
AB  - PURPOSE: The purpose of this first in-human study was to evaluate the overall 
      clinical performance of the VERITAS Vision System in patients scheduled to 
      undergo cataract extraction and to confirm overall surgeon acceptability. 
      PATIENTS AND METHODS: This prospective, open-label multinational study included 
      adults with cataracts scheduled for planned cataract extraction and posterior 
      chamber IOL implantation. Standard small-incision phacoemulsification cataract 
      surgery with the VERITAS Vision System was conducted. Surgeons completed a 
      questionnaire regarding their clinical experience with the VERITAS Vision System 
      for each patient following surgery and 1-day postoperative. Corneal clarity and 
      adverse events (AEs) were assessed. Surgeon acceptability was scored on a 5-point 
      scale, with acceptability considered favorable for scores of 4 and 5. RESULTS: A 
      total of 115 eyes (79 patients) were treated. The El Salvador site treated 41 
      patients (58 eyes), and the US site treated 38 patients (57 eyes). Overall, 
      surgeons were satisfied with the clinical performance regardless of the cataract 
      grade. The satisfaction with anterior chamber stability, post-occlusion surge, 
      followability, holdability, cutting efficiency, usability, and overall 
      satisfaction with the VERITAS Vision System was clinically favorable in >/=99% of 
      cases. Overall satisfaction with the swivel handpiece, foot pedal, and enhanced 
      ergonomics were clinically favorable in >/=97% of cases regardless of the cataract 
      grade. Satisfaction with corneal clarity at same-day postoperative and 1-day 
      postoperative, and 1-day overall clinical results of surgery with the VERITAS 
      Vision System were clinically favorable in >/=94% of cases regardless of cataract 
      grade. CONCLUSION: The new dual-mode phacoemulsification system with 
      dual-durometer tubing, gas forced infusion, new swivel handpiece, and ergonomics 
      improvements resulted in a high rate of user satisfaction with clinical 
      performance and ergonomics. The VERITAS Vision System is safe and effective when 
      used as indicated.
CI  - (c) 2022 Quesada et al.
FAU - Quesada, Gabriel
AU  - Quesada G
AD  - Grupo Oftalmo & Plastico, San Salvador, El Salvador.
FAU - Chang, Daniel H
AU  - Chang DH
AUID- ORCID: 0000-0001-6307-6342
AD  - Empire Eye and Laser Center, Bakersfield, CA, USA.
FAU - Waltz, Kevin L
AU  - Waltz KL
AD  - Central American Ophthalmic Research Consultants, Indianapolis, IN, USA.
FAU - Kao, Andrew A
AU  - Kao AA
AD  - Empire Eye and Laser Center, Bakersfield, CA, USA.
FAU - Quesada, Rodrigo
AU  - Quesada R
AD  - Grupo Oftalmo & Plastico, San Salvador, El Salvador.
FAU - Wang, Ying
AU  - Wang Y
AD  - Johnson & Johnson Surgical Vision, Inc, Santa Ana, CA, USA.
FAU - Ji, Leilei
AU  - Ji L
AD  - Johnson & Johnson Surgical Vision, Inc, Santa Ana, CA, USA.
FAU - Parizadeh, Dari
AU  - Parizadeh D
AD  - Johnson & Johnson Surgical Vision, Inc, Santa Ana, CA, USA.
FAU - Atiles, Luis
AU  - Atiles L
AD  - Johnson & Johnson Surgical Vision, Inc, Santa Ana, CA, USA.
LA  - eng
PT  - Case Reports
PT  - Clinical Trial
DEP - 20220806
PL  - New Zealand
TA  - Clin Ophthalmol
JT  - Clinical ophthalmology (Auckland, N.Z.)
JID - 101321512
PMC - PMC9365053
OTO - NOTNLM
OT  - VERITAS Vision System
OT  - cataract
OT  - ergonomics
OT  - fluidics
OT  - satisfaction
COIS- GQ, DHC, KLW, AK, and RQ are consultants to Johnson & Johnson Surgical Vision, 
      Inc. YW, LJ, DP, and LA are employees of Johnson & Johnson Surgical Vision, Inc. 
      DHC reports grants, personal fees, and non-financial support from Johnson & 
      Johnson Vision during the conduct of the study; grants, personal fees, and 
      non-financial support from Johnson & Johnson Vision; and personal fees from Carl 
      Zeiss Meditec outside the submitted work. AK reports grants from Johnson and 
      Johnson during the conduct of the study; consulting fees and travel arrangements 
      for Veritas Surgical System meeting at their headquarters July 2021 from Johnson 
      and Johnson; grants; and lecture fees for dinner meeting January 2020; and 
      research and grant support for clinical trial ongoing from Glaukos outside the 
      submitted work. The authors report no other conflicts of interest in this work.
EDAT- 2022/08/16 06:00
MHDA- 2022/08/16 06:01
PMCR- 2022/08/06
CRDT- 2022/08/15 04:08
PHST- 2022/02/18 00:00 [received]
PHST- 2022/07/25 00:00 [accepted]
PHST- 2022/08/15 04:08 [entrez]
PHST- 2022/08/16 06:00 [pubmed]
PHST- 2022/08/16 06:01 [medline]
PHST- 2022/08/06 00:00 [pmc-release]
AID - 363061 [pii]
AID - 10.2147/OPTH.S363061 [doi]
PST - epublish
SO  - Clin Ophthalmol. 2022 Aug 6;16:2441-2451. doi: 10.2147/OPTH.S363061. eCollection 
      2022.