Clinical Comparison of Patients Implanted With Clear Hydrogel Corneal Inlay Under Various Femtosecond Laser Flap Thicknesses
To assess visual outcomes and safety of the Raindrop Near Vision Inlay implanted under various femtosecond laser flap thicknesses.
Prospective, multicenter, series of cases. Emmetropes (refractions) implanted with the Raindrop Inlay in the non-dominant eye under a thicker femtosecond flap (A group) with a target flap of 32% to 34% of the central corneal thickness (CCT) versus a thinner flap (B group) with target of 24% to 28% of CCT. ETDRS visual acuities at various distances, visual symptoms (glare, halos), and ocular discomfort (dryness, pain, light sensitivity), cornea clarity were evaluated at 1M, 3M, 6M, and 12M.
The A group with mean age of 51.6 yrs (SD: 4.1) was implanted at a target depth of 33%. The B group with mean age of 50.3 yrs (SD: 3.9) was implanted at a target depth of 26%. Monocularly in the inlay eye at 12M, mean UNVA was 20/20 in the A group versus 20/21 in the B group. Both groups maintained high patient satisfaction (93%-A, 92%-B) and low reports of moderate or worse ocular dryness (3%-A, 0%-B). The A group showed less corneal reaction with 93% of patients with clear corneas versus 87% in the B group.
Raindrop Inlay provided equally good visual performance at near and distance, low reports of ocular dryness, and high overall patient satisfaction regardless of targeted flap depth (33% vs. 26%). The thicker flap group A showed less corneal reaction with 93% of patients with clear corneas.