PMID- 29438120
OWN - NLM
STAT- MEDLINE
DCOM- 20181211
LR  - 20181211
IS  - 1542-233X (Electronic)
IS  - 1542-2321 (Linking)
VI  - 44 Suppl 2
DP  - 2018 Nov
TI  - MiSight Assessment Study Spain: Adverse Events, Tear Film Osmolarity, and 
      Discontinuations.
PG  - S180-S186
LID - 10.1097/ICL.0000000000000484 [doi]
AB  - OBJECTIVES: To assess the relative clinical success of MiSight contact lenses 
      (CLs) (study group) and distance single-vision (SV) spectacles (control group) in 
      children in terms of adverse events (AEs), discontinuations, and tear film 
      osmolarity over a 2-year period. METHODS: Seventy-four subjects aged 8 to 12 with 
      myopia of -0.75 to -4.00 D and astigmatism less than 1.00 D were randomly 
      assigned to MiSight CLs or SV groups. Subjects were monitored at 6-month 
      intervals over the course of 24 months and advised to report to the clinic 
      immediately should AEs occur. Adverse events were categorized as serious, 
      significant, and nonsignificant. Discontinuation was defined as cessation of 
      participation in the study. RESULTS: Forty-four children were corrected with 
      MiSight CLs and 33 with SV spectacles. No serious or significant AEs were found 
      in any of the participants in either group. Two nonsignificant AEs were found in 
      MiSight group, corresponding to a foreign body on the cornea in two children. 
      There were five discontinuations in MiSight group, one because of change of 
      residence and four because of unwillingness to use the CL. There were no 
      discontinuations in SV group. Neither group showed any significant changes in 
      osmolarity data over the 24 months of follow-up (P>/=0.05). CONCLUSIONS: No 
      clinically serious events were observed in either group. Our results show that 
      correct use of MiSight CLs is a safe option for myopia correction. The success of 
      this treatment requires a combination of proper lens fitting, good adherence to 
      routine follow-ups, and timely treatment of complications.
FAU - Ruiz-Pomeda, Alicia
AU  - Ruiz-Pomeda A
AD  - Department of Pharmacy, Biotechnology, Optics and Optometry (A.R.-P.), 
      Universidad Europea de Madrid, Madrid, Spain; Department of Statistics, 
      Mathematics and Informatics (B.P.-S.), Miguel Hernandez University of Elche, 
      Elche, Spain; Department Optics I: Optometry and Vision (F.L.P.-G.), Universidad 
      Complutense de Madrid, Madrid, Spain; Clinica Oftalmologica Novovision (R.G.-O.), 
      Madrid, Spain; and Doctoral and Research School (C.V.-C.), Universidad Europea de 
      Madrid, Madrid, Spain.
FAU - Perez-Sanchez, Belen
AU  - Perez-Sanchez B
FAU - Prieto-Garrido, Francisco L
AU  - Prieto-Garrido FL
FAU - Gutierrez-Ortega, Ramon
AU  - Gutierrez-Ortega R
FAU - Villa-Collar, Cesar
AU  - Villa-Collar C
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Eye Contact Lens
JT  - Eye & contact lens
JID - 101160941
SB  - IM
MH  - Analysis of Variance
MH  - Astigmatism/physiopathology/*therapy
MH  - Child
MH  - *Contact Lenses, Hydrophilic/adverse effects
MH  - Corneal Diseases/*etiology/physiopathology
MH  - *Eyeglasses/adverse effects
MH  - Female
MH  - Humans
MH  - Male
MH  - Myopia/physiopathology/*therapy
MH  - Orthokeratologic Procedures/*adverse effects/methods
MH  - Osmolar Concentration
MH  - Tears/*physiology
EDAT- 2018/02/14 06:00
MHDA- 2018/12/12 06:00
CRDT- 2018/02/14 06:00
PHST- 2018/02/14 06:00 [pubmed]
PHST- 2018/12/12 06:00 [medline]
PHST- 2018/02/14 06:00 [entrez]
AID - 10.1097/ICL.0000000000000484 [doi]
PST - ppublish
SO  - Eye Contact Lens. 2018 Nov;44 Suppl 2:S180-S186. doi: 
      10.1097/ICL.0000000000000484.