<
p>
<
strong>
Purpose:<
/strong>
To assess the safety of scleral-lens designs, we model and clinically assess central corneal edema induced by scleral-lens wear for healthy subjects. <
/p>
<
p>
<
strong>
Materials and Methods: <
/strong>
Typically, central corneal swelling during scleral-lens wear is measured using optical coherence tomography (OCT). Transport resistances are modeled for oxygen diffusion through the scleral lens and post-lens tear-film (PoLTF), and into the cornea. Oxygen deficiency in the cornea activates anaerobic metabolic reactions that induce corneal edema. Oxygen permeability, carbon-dioxide permeability, settled-lens PoLTF thickness, and scleral-lens thickness are varied in the calculations to mimic different lens fits. <
/p>
<
p>
<
strong>
Results:<
/strong>
Transport modeling predicts that for open eyes, increasing PoLTF thickness from 50 to 400��m increases central corneal swelling by approximately 1?1.5% when oxygen transmissibility (<
em>
Dk/L<
/em>
) is greater than 10 hBarrer/cm (i.e., hectoBarrer/cm). Although swelling is larger for oxygen <
em>
Dk/L<
/em>
�<
�10 hBarrer/cm, PoLTF thickness has minimal impact in this range. For open eye, oxygen transmissibility of the lens plays a significant role in corneal edema, but is negligible when oxygen <
em>
Dk/L<
/em>
is >
�40 hBarrer/cm. For closed eye, central corneal swelling is greater than 5% for an oxygen <
em>
Dk/L<
/em>
range of 0?100 hBarrer/cm with typical lens-fitting parameters. For carbon-dioxide transmissibilities increasing from 50 to 250 hBarrer/cm and with a fixed oxygen <
em>
Dk/L<
/em>
of 25 hBarrer/cm, calculated swelling diminishes by an additional 0.5%. Comparison of model calculations to clinical-swelling data is within the error range of the clinical measurements. <
/p>
<
p>
<
strong>
Conclusions:<
/strong>
Oxygen/metabolite transport calculations for open-eye scleral-lens wear demonstrate that normal PoLTF thicknesses fitted by clinicians (i.e., PoLTF thicknesses <
�400��m) with modern scleral lenses (i.e., oxygen <
em>
Dk/L<
/em>
�>
�25 hBarrer/cm) produce corneal swelling of less than 2% in agreement with experiment. Therefore, scleral lenses prescribed today evoke less than physiological hypoxic swelling (i.e., less than 4%) for healthy corneas during open-eye. Closed-eye wear, however, appears clinically unsafe.<
/p>