Purpose: To examine the hypothesis that the corneal overnight swelling response (ONSR) is a predictor of ocular complications in contact lens extended wear (EW).
Methods: The Berkeley Contact Lens Extended Wear Study (CLEWS) was a randomized, concurrently controlled clinical trial in which more than 200 subjects in EW with rigid gas-permeable (RGP) lenses were observed for 1 year. After adapting to EW, subjects were randomized to either medium or high oxygen-permeable (Dk) RGP lenses and underwent clinical assessments, keratometry, and corneal pachometry at 3-month intervals.
Results: The ONSR was directly related to lens Dk (P = 0.01) and exhibited substantial variability across subjects. The probability of remaining free of complications over time was not significantly lower for subjects with a mild ONSR compared with those with greater edema (P = 0.84). The risk of development of keratopathy was not significantly related to the ONSR (relative risk = 1.00).
Conclusions: The corneal ONSR is not a good predictor of ocular complications in 1 year of RGP EW. Lenses that cause little or no corneal edema are not necessarily safer for overnight wear.