Single-Center Experience With Hydrogel Corneal Inlay for Correction of Presbyopia in Emmetropic Eyes
Narrative Responses:
Purpose
To evaluate my cohort of subjects implanted with a Raindrop™ Near Vision Inlay (ReVision Optics, Inc., Lake Forest, CA) as part of a multicenter prospective FDA IDE study.
Methods
Forty-five (45) 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 a light constricted pupil. The implant is designed to change the curvature of the overlying cornea creating a gradient of power that allows near and intermediate vision. ETDRS visual acuities were collected in the Optec Vision Tester (Stereo Optical CO, Chicago, IL) at near (40cm), intermediate (80cm), and distance (4m) at preop, 1W, 1M, 3M, and 6M postop. NEI Quality of Life questionnaires on visual symptoms and patient satisfaction were also evaluated.
Results
At 6 months (n=18), monocular near and intermediate visual acuities (logMAR) improved from pre-op (UNVA 0.52 to 0.01; UIVA 0.4 to 0.08). DCNVA (to eliminate the effect of refractive errors) 20/25 or better was achieved by 89% of eyes; average DCNVA improved from 0.44 preop to 0.06 at 6 months. 83% achieved monocular UDVA 20/25 or better. Binocularly, all subjects were 20/25 or better at near, 20/32 or better at intermediate, and 20/20 or better at distance. All subjects achieved 20/20 or better CDVA. Patient satisfaction was 94%.
Conclusion
Raindrop improved near vision by 5 lines and intermediate by 3 lines. There was no compromise to distance vision which is one of the main drawbacks of the monovision approach. Lack of photic phenomena and excellent patient satisfaction also supports this corneal inlay as a valid tool to treat presbyopia.