The short-term physiological impact of switching reusable silicone hydrogel wearers into a hydrogel daily disposable multifocal
Received 16 March 2019
Accepted for publication 14 May 2019
Published 10 July 2019 Volume 2019:13 Pages 1193—1202
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 3
Editor who approved publication: Dr Scott Fraser
Amir M Moezzi,1 Jalaiah Varikooty,1 Doerte Luensmann,1 Marc-Matthias Schulze,1 Alison Ng,1 Thomas Karkkainen,2 Jing Xu,2 Lyndon Jones1
1Centre for Ocular Research & Education (CORE, formerly Centre for Contact Lens Research), School of Optometry and Vision Science, University of Waterloo, Waterloo, Ontario, Canada; 2Research and Development, Johnson & Johnson Vision, Jacksonville, FL, USA
Purpose: To evaluate ocular physiological responses to etafilcon A multifocal (etMF) daily disposable (DD) lenses after 4 weeks of wear, when switching from habitual silicone hydrogel (SiHy) daily wear.
Method: A single-arm, open-label, bilateral dispensing study was conducted in 39 habitual spherical SiHy wearers (14 hyperopes; 25 myopes). Clinical visits occurred with habitual SiHy (control) at baseline and after 4 weeks of etMF DD open-eye lens wear at exit. Objective limbal/bulbar hyperemia using the Oculus K5M (0–4) and subjective grading of lid wiper epitheliopathy (LWE) (0–4) were tested for non-inferiority (NI), using a margin of 1 grade. Corneal thickness along a 10 mm cord was measured using the Visante OCT and tested for NI using a 30 μm margin. Corneal staining area was graded (0–100%).
Results: The least-square mean differences (LSMD) and 95% confidence interval (95% CI) between etMF DD and habitual SiHy in central and peripheral corneal thickness (μm) were 3.64 (−2.0, 9.29) and 3.0 (−7.72, 13.72) in hyperopic, and 3.56 (−0.66, 7.78) and 6.40 (−1.62, 14.42) in myopic subjects. The LSMD (95% CI) for bulbar and limbal hyperemia were −0.08 (−0.19, 0.02) and −0.01 (−0.12, 0.09) in hyperopes, and 0.04 (−0.03, 0.12) and 0.04 (−0.04, 0.11) in myopes. The LSMD (95% CI) for LWE were 0.11 (−0.39, 0.60) and 0.30 (−0.07, 0.67) for hyperopes and myopes, respectively.
Conclusions: No clinically significant differences in a variety of physiological responses were found when habitual reusable SiHy daily wear subjects were refitted into hydrogel etMF, when the subjects were followed for 4 weeks.
Keywords: corneal swelling, corneal thickness, limbal hyperemia, oxygen transmissibility, presbyopia, OCT
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