PMID- 33179359
OWN - NLM
STAT- MEDLINE
DCOM- 20211122
LR  - 20211122
IS  - 1475-1313 (Electronic)
IS  - 0275-5408 (Print)
IS  - 0275-5408 (Linking)
VI  - 41
IP  - 1
DP  - 2021 Jan
TI  - Adverse event rates in the retrospective cohort study of safety of paediatric 
      soft contact lens wear: the ReCSS study.
PG  - 84-92
LID - 10.1111/opo.12753 [doi]
AB  - PURPOSE: To ascertain the safety of soft contact lens (SCL) wear in children 
      through a retrospective chart review including real-world clinical practice 
      settings. METHODS: The study reviewed clinical charts from 963 children: 782 
      patients in 7 US eye care clinics and 181 subjects from 2 international 
      randomised clinical trials (RCTs). Subjects were first fitted while 8-12 years 
      old with various SCL designs, prescriptions and replacement schedules, and 
      observed through to age 16. Clinical records from visits with potential adverse 
      events (AEs) were electronically scanned and reviewed to consensus by an 
      Adjudication Panel. RESULTS: The study encompassed 2713 years-of-wear and 4611 
      contact lens visits. The cohort was 46% male, 60% were first fitted with daily 
      disposable SCLs, the average age at first fitting was 10.5 years old, with a mean 
      of 2.8 +/- 1.5 years-of-wear of follow-up observed. There were 122 potential ocular 
      AEs observed from 118/963 (12.2%) subjects; the annualised rate of non-infectious 
      inflammatory AEs was 0.66%/year (95% CI 0.39-1.05) and 0.48%/year (0.25-0.82) for 
      contact lens papillary conjunctivitis. After adjudication, two presumed or 
      probable microbial keratitis (MK) cases were identified, a rate of 
      7.4/10 000 years-of-wear (95% CI 1.8-29.6). Both were in teenage boys and one 
      resulted in a small scar without loss of visual acuity. CONCLUSION: This study 
      estimated the MK rate and the rate of other inflammatory AEs in a cohort of SCL 
      wearers from 8 through to 16 years of age. Both rates are comparable to 
      established rates among adults wearing SCLs.
CI  - (c) 2020 The Authors. Ophthalmic and Physiological Optics published by John Wiley & 
      Sons Ltd on behalf of College of Optometrists.
FAU - Chalmers, Robin L
AU  - Chalmers RL
AUID- ORCID: 0000-0003-3724-5872
AD  - Clinical Trial Consultant, Atlanta, USA.
FAU - McNally, John J
AU  - McNally JJ
AD  - CooperVision, Inc., Pleasanton, USA.
FAU - Chamberlain, Paul
AU  - Chamberlain P
AD  - CooperVision, Inc., Pleasanton, USA.
FAU - Keay, Lisa
AU  - Keay L
AD  - School of Optometry and Vision Science, UNSW Sydney, Sydney, NSW, Australia.
AD  - The George Institute for Global Health, UNSW Sydney, Sydney, NSW, Australia.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20201111
PL  - England
TA  - Ophthalmic Physiol Opt
JT  - Ophthalmic & physiological optics : the journal of the British College of 
      Ophthalmic Opticians (Optometrists)
JID - 8208839
SB  - IM
MH  - Adolescent
MH  - Child
MH  - Contact Lenses, Hydrophilic/*adverse effects
MH  - Corneal Ulcer/epidemiology/*microbiology
MH  - Disposable Equipment
MH  - Eye Infections, Bacterial/epidemiology/*microbiology
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Inflammation/epidemiology/*etiology
MH  - Male
MH  - Myopia/*therapy
MH  - Prosthesis Fitting
MH  - Retrospective Studies
PMC - PMC7839756
OTO - NOTNLM
OT  - adverse events
OT  - epidemiology
OT  - myopia control contact lenses
OT  - paediatric
COIS- Robin Chalmers is a consultant for AcuFocus Inc., Alcon Research, Ltd., 
      CooperVision Inc., Johnson & Johnson Vision, Inc., and Vision Service Plan, Inc. 
      John McNally and Paul Chamberlain are employees of CooperVision, Inc. Lisa Keay 
      is a consultant for CooperVision, Inc.
EDAT- 2020/11/13 06:00
MHDA- 2021/11/23 06:00
PMCR- 2021/01/27
CRDT- 2020/11/12 05:48
PHST- 2020/07/29 00:00 [received]
PHST- 2020/09/10 00:00 [revised]
PHST- 2020/09/30 00:00 [accepted]
PHST- 2020/11/13 06:00 [pubmed]
PHST- 2021/11/23 06:00 [medline]
PHST- 2020/11/12 05:48 [entrez]
PHST- 2021/01/27 00:00 [pmc-release]
AID - OPO12753 [pii]
AID - 10.1111/opo.12753 [doi]
PST - ppublish
SO  - Ophthalmic Physiol Opt. 2021 Jan;41(1):84-92. doi: 10.1111/opo.12753. Epub 2020 
      Nov 11.