PMID- 21616703
OWN - NLM
STAT- MEDLINE
DCOM- 20120319
LR  - 20110720
IS  - 1476-5411 (Electronic)
IS  - 1367-0484 (Linking)
VI  - 34
IP  - 4
DP  - 2011 Aug
TI  - Prospective multicenter trial assessing effectiveness, refractive predictability 
      and safety of a new aberration free, bi-aspheric intraocular lens.
PG  - 188-92
LID - 10.1016/j.clae.2011.04.003 [doi]
AB  - PURPOSE: To determine the effectiveness and safety of the Softec HD IOL; and to 
      present refractive outcomes for lenses manufactured at an IOL power tolerance of 
      0.11 D. METHODS: Three-hundred and ninety adult patients requiring removal of a 
      cataractous lens with implantation of a monofocal IOL in at least one eye were 
      eligible for study participation across eight US investigative sites. Patients 
      were enrolled unilaterally. After routine surgery, subjects were examined for 
      adverse events (AEs), best corrected visual acuity (BCVA) and manifest refraction 
      correction at 12 months postoperatively. RESULTS: Three-hundred and sixty-six 
      (95%) of patients completed the 12-month postoperative visit. The percent of 
      patients achieving best corrected Snellen acuity 20/40 or better was 98.9%, and 
      81.1% of patients achieved best corrected Snellen acuity 20/25 or better. Of 
      those patients (80%) implanted with a lens available in 0.25 D increments 
      (manufactured at a tolerance of 0.11 D) 40.9%, 69.8% and 93.8% of patients were 
      within +/-0.25 D, +/-0.50 D and +/-1.0 D of predicted target refraction respectively. 
      Overall incidence of cumulative and persistent IOL Grid AEs was 2.2% with no AE 
      meeting or exceeding the FDA Grid of Historical Controls. CONCLUSIONS: The Softec 
      HD IOL is a safe and effective lens. The high manufacturing tolerance of the lens 
      appears to enhance refractive outcomes.
CI  - Copyright (c) 2011 British Contact Lens Association. Published by Elsevier Ltd. All 
      rights reserved.
FAU - Brown, David C
AU  - Brown DC
AD  - Eye Centers of Florida, Fort Myers, FL 33901, USA. david.brown@ecof.com
FAU - Gills, J Pit 3rd
AU  - Gills JP 3rd
FAU - Trattler, William B
AU  - Trattler WB
FAU - Newsom, T Hunter
AU  - Newsom TH
FAU - Weinstock, Robert J
AU  - Weinstock RJ
FAU - Sanders, Donald R
AU  - Sanders DR
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20110525
PL  - England
TA  - Cont Lens Anterior Eye
JT  - Contact lens & anterior eye : the journal of the British Contact Lens Association
JID - 9712714
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Equipment Failure Analysis
MH  - Female
MH  - Humans
MH  - Lenses, Intraocular/*adverse effects
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Prosthesis Design
MH  - Refractive Errors/*rehabilitation
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2011/05/28 06:00
MHDA- 2012/03/20 06:00
CRDT- 2011/05/28 06:00
PHST- 2011/02/24 00:00 [received]
PHST- 2011/04/14 00:00 [revised]
PHST- 2011/04/14 00:00 [accepted]
PHST- 2011/05/28 06:00 [entrez]
PHST- 2011/05/28 06:00 [pubmed]
PHST- 2012/03/20 06:00 [medline]
AID - S1367-0484(11)00063-4 [pii]
AID - 10.1016/j.clae.2011.04.003 [doi]
PST - ppublish
SO  - Cont Lens Anterior Eye. 2011 Aug;34(4):188-92. doi: 10.1016/j.clae.2011.04.003. 
      Epub 2011 May 25.