PMID- 29910600
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220317
IS  - 1177-5467 (Print)
IS  - 1177-5483 (Electronic)
IS  - 1177-5467 (Linking)
VI  - 12
DP  - 2018
TI  - Prospective multicenter clinical trial to evaluate the safety and effectiveness 
      of a new glistening-free one-piece acrylic toric intraocular lens.
PG  - 1031-1039
LID - 10.2147/OPTH.S167726 [doi]
AB  - PURPOSE: Glistening formation in the intraocular lens (IOL) optic has the 
      potential to impact quality of vision. The enVista One-Piece Hydrophobic Acrylic 
      Spherical IOL Model MX60 (MX60 IOL) is currently the only US Food and Drug 
      Administration-approved IOL with a label of "no glistenings". The purpose of this 
      prospective, multicenter, partially randomized, partially controlled, 
      double-masked, pivotal study was to evaluate the safety and effectiveness of the 
      enVista One-Piece Hydrophobic Acrylic MX60T Toric IOL (enVista MX60T Toric IOL). 
      PATIENTS AND METHODS: Subjects (n=191) were implanted with the enVista MX60T 
      Toric IOL (cylinder powers 1.25, 2.00, or 2.75 D) or the parent MX60 IOL 
      (control). Eyes within the lowest range of corneal astigmatism were randomized to 
      receive either Toric 1.25 D IOL or control IOL in a 1:1 ratio. All subjects with 
      corneal astigmatism requiring 2.00 or 2.75 D cylinder IOLs received toric IOLs. 
      Rotational stability, cylinder reduction, and best-corrected distance visual 
      acuity were primary effectiveness endpoints measured at Visit 4 (120-180 days 
      postoperatively). RESULTS: Visit 4 mean absolute axis misalignment in the All 
      Toric group was 4.68 degrees +/-7.33 degrees , and all subjects had </=5 degrees  absolute rotation from 
      Visit 3 to Visit 4. The 1.25 D group had significantly greater improvement in 
      dioptric cylinder reduction (P<0.001), percent cylinder reduction (P<0.001), and 
      mean uncorrected distance visual acuity (P<0.001), compared to control at Visit 
      4. Most adverse events (AEs) were mild, with no serious AEs in the study eyes. 
      The rates of cumulative AEs through Visit 4 were below International Organization 
      for Standardization (ISO) standard 11979-7 AE rates. CONCLUSION: enVista MX60T 
      Toric IOL is safe and effective for patients with preoperative corneal 
      astigmatism undergoing IOL implantation.
FAU - Packer, Mark
AU  - Packer M
AD  - Mark Packer MD Consulting, Inc., Boulder, CO, USA.
FAU - Williams, Jon I
AU  - Williams JI
AD  - Surgical Clinical and Medical Affairs, Bausch & Lomb Inc., Irvine, CA, USA.
FAU - Feinerman, Gregg
AU  - Feinerman G
AD  - Feinerman Vision Center, Newport Beach, CA, USA.
FAU - Hope, Richard S
AU  - Hope RS
AD  - Surgical Clinical and Medical Affairs, Bausch & Lomb Inc., Irvine, CA, USA.
LA  - eng
PT  - Journal Article
DEP - 20180601
PL  - New Zealand
TA  - Clin Ophthalmol
JT  - Clinical ophthalmology (Auckland, N.Z.)
JID - 101321512
PMC - PMC5987786
OTO - NOTNLM
OT  - IOL
OT  - astigmatism
OT  - cataract
OT  - clinical
OT  - enVista
OT  - human
COIS- Disclosure Dr Williams and Dr Hope are employees of Bausch & Lomb; Dr Packer and 
      Dr Feinerman are consultants to Bausch & Lomb. The authors report no other 
      conflicts of interest in this work.
EDAT- 2018/06/19 06:00
MHDA- 2018/06/19 06:01
PMCR- 2018/06/01
CRDT- 2018/06/19 06:00
PHST- 2018/06/19 06:00 [entrez]
PHST- 2018/06/19 06:00 [pubmed]
PHST- 2018/06/19 06:01 [medline]
PHST- 2018/06/01 00:00 [pmc-release]
AID - opth-12-1031 [pii]
AID - 10.2147/OPTH.S167726 [doi]
PST - epublish
SO  - Clin Ophthalmol. 2018 Jun 1;12:1031-1039. doi: 10.2147/OPTH.S167726. eCollection 
      2018.