Using Transparent Hydrogel Inlay to Create Profocal Shape Cornea: Clinical Trial Update
Purpose
To evaluate visual outcomes and overall satisfaction in emmetropic presbyopes unilaterally implanted with a transparent hydrogel corneal inlay (Raindrop Near Vision Inlay, ReVision Optics, Inc.) as part of a US FDA IDE study.
Methods
As part of a multi-center, non-randomized, prospective FDA IDE study, 373 subjects were enrolled into the study. ETDRS visual acuities were collected at various distances preoperative, 1W, 1M, 3M, 6M, 9M, 12M, 18M, and 24M postoperatively. Ocular symptoms and patient satisfaction were evaluated with a validated NEI Quality of Life questionnaire. Endothelial cell loss (ECL) and explant rates will also be analyzed.
Results
Interim data at 12M (n= 328), 94% of patients were 20/25 or better binocularly at all distances (near, intermediate, and distance). Monocularly at 12M in the inlay eye, 93% of patients were 20/25 or better (UNVA) and 85% of patients were 20/32 or better (UDVA). Overall patient satisfaction was high at 93% being Somewhat Satisfied, Very Satisfied, or Completely Satisfied. Complications were minimal with 3% explant rate and ECL of 0.26% from preop to 12M.
Conclusion
Raindrop Inlay provided patients with good binocular acuity (near, intermediate, distance) with 94% of patients seeing 20/25 or better at all distances at 12M. A combination of good visual performance and minimal complications ultimately achieved high patient satisfaction of 93%.