Creating Range of Uninterrupted Vision Using Nonrefractive Hydrogel Corneal Inlay
To evaluate a subset of subjects implanted with a Raindrop Near Vision Inlay (ReVision Optics, Inc.) as part of a multicenter prospective FDA IDE study.
Thirty (30) emmetropic presbyopes (MRSE -0.50 D to +1.00 D) were implanted with a hydrogel (FDA investigational device) in the non-dominant eye under a femtosecond flap. The implant is designed to change the curvature of the overlying cornea creating a gradient of power that allows a full range of uninterrupted vision. ETDRS visual acuities were collected in the Optec Vision Tester (Stereo Optical CO, Chicago, IL) at near (40 cm), intermediate (80 cm), and distance (6 m) at preop, 1W, 1M, 3M, and 12M postop. Defocus curves and contrast sensitivity were measured as part of a substudy at preop and 12M.
At 12 months (n=30), monocular near and intermediate visual acuities improved from preop (UNVA 20/72 to 20/22; UIVA 20/46 to 20/26). Binocularly, all subjects were 20/32 or better at near, 20/32 or better at intermediate, and 20/20 or better at distance. Defocus curve measurements showed an extended depth of focus with minus lenses when compared to preop (20/40 or better from +1.0 D to -3.0 D). Mesopic contrast sensitivity in the inlay eye showed no difference preop to 12M. Overall patient satisfaction in this cohort of subjects was high at 93%.
The hydrogel inlay improved range of vision by extending the depth of focus from +1.0 D to -3.0 D. All patients showed functional binocular vision at all distances without effecting mesopic contrast sensitivity.