Early Commercial Experience With Nonrefractive Hydrogel Corneal Inlay for Correction of Presbyopia
Purpose
To report my early clinical results in presbyopes implanted unilaterally with Raindrop Near Vision Inlay. Reporting both refractive and surgical experience from a new implanting surgeon.
Methods
Case series on my first patients implanted with Raindrop Inlay in a single site setting. Unilateral implantation in the non-dominant eye and centered over the miotic pupil. Manifest refraction, distance (6 meters) and near (40 cm and preferred distance) visual acuities were collected at preop, 1W, 1M, and 3M.
Results
Mean age (range): 54.3 (45 to 64) years old at preop. Interim analysis at 1M (n=7), average uncorrected distance VA in the inlay eye was 20/32. Uncorrected near VAs at 40 cm and preferred distance showed 66.6% of inlay eyes were 20/20 or better and 100% were 20/32 or better with a preferred working distance of 38 cm. 100% of patients were satisfied or very satisfied. Complications were low with one case of microstriae at 1 day with complete resolution by 1 month.
Conclusion
Initial Raindrop refractive results delivered very consistent near improvement of 20/32 or better. Low complication rates and high patient satisfaction in my cases make this an exciting and valuable addition to my armamentarium for presbyopia correction.
* CAUTION: Investigational device. Limited by Federal United States law to investigational use