Clear Nonrefractive Hydrogel Corneal Inlay for Correction of Presbyopia in Emmetropic Eyes: Single-Center Clinical Results
Purpose
To evaluate my cohort of subjects implanted with a Raindrop Near Vision Inlay (ReVision Optics, Inc.) as part of a multicenter prospective FDA IDE study.
Methods
Thirty-nine (39) emmetropic presbyopes (MRSE -0.50 to +1.00) were implanted with the Raindrop Inlay (FDA investigational device) in the non-dominant eye under a femtosecond flap, centered over the light-constricted pupil. The implant is designed to change the curvature of the overlying cornea creating a gradient of power that improves near and intermediate vision. ETDRS visual acuities were collected in the Optec Vision Tester (Stereo Optical CO) at near (40 cm), intermediate (80 cm), and distance (6 m) at preop, 1W, 1M, 3M, 12M postop. NEI Quality of Life questionnaires on visual symptoms and patient satisfaction were also evaluated.
Results
At 12 months (n=28), monocular near and intermediate visual acuities (logMAR) improved from preop (UNVA 0.63 to 0.04; UIVA 0.44 to 0.09). DCNVA (to eliminate the effect of refractive errors) improved from 0.54 preop to 0.01 at 12 months. Binocularly, all subjects were 20/25 or better at near, 20/40 or better at intermediate, and 20/20 or better at distance. Overall patient satisfaction was high at 96%.
Conclusion
Raindrop Inlay improved near vision by nearly 6 lines of acuity and intermediate vision by 3.5 lines. The full range of vision and high patient satisfaction supports this corneal inlay as a valid tool to treat presbyopia.