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Alan J Lang, Arturo Chayet, Enrique Barragán-Garza; Remodeling of the Cornea Induced by a Shape-Changing Hydrogel Inlay. Invest. Ophthalmol. Vis. Sci. 2016;57(12):2378.
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© 2017 Association for Research in Vision and Ophthalmology.
Assess epithelial and stromal remodeling anterior to a hydrogel inlay placed within the cornea.
The analysis was performed on subjects (N = 30) enrolled in a prospective clinical investigation of the Raindrop® Near Vision Inlay, implanted in corneal of the non-dominate eye of emmetropic presbyopic subjects. The inlay had a meniscus shape with a 2 mm diameter and a 34 micron central thickness. The inlay was placed beneath a targeted 150 microns corneal flap (femtosecond laser), over the center of the light constricted pupil. The change to the anterior corneal surface profile (△C) was measured using postoperative minus preoperative wavefront measurements. The change to the epithelial thickness profile (△E) was measured using Fourier domain optical coherence tomography (OCT). Changes to the anterior stroma (flap) were reflected in alteration of Bowman’s layer shape (△Bow) and visible OCT images, but this changes was more accurately calculated from the above two measurements; △Bow = △C - △E.
When placed on the flap bed, the inlay’s volume displaced stroma anterior to the inlay, with 91% of the inlay volume reflected in the change to Bowman’s layer directly above the inlay’s diameter. The 8% loss is approximately accounted for by a slight increase in stromal volume just outside the inlay diameter. Bowman’s layer rose centrally by 28 ± 8.5 microns, 85% of the inlay’s central thickness. The stromal rise thinned the overlying epithelium by -18 ± 5.1 microns, equivalent to 35% of the preoperative epithelial thickness. The volume of the epithelium thinned was redistributed peripheral to the inlay diameter (2 mm), extending the change at the anterior corneal surface to about twice the inlay diameter. The central anterior corneal surface rose by 10 ± 3.2 microns, creating a progressive Add power profile with a central peak of -5 D.
When a meniscus shaped corneal inlay is placed beneath a corneal flap, epithelial remodeling redistributed most of the inlay’s volume, with a much smaller biomechanical remodeling of the stroma anterior to the inlay.*CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
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