Profocal cornea: mechanism of action of a transparent corneal inlay and clinical implications

Session Details

Session Title: Presbyopic Corrections

Session Date/Time: Monday 15/09/2014 | 16:30-18:30

Paper Time: 17:16

Venue: Boulevard F (Level 1)

First Author: : J.Güell SPAIN

Co Author(s): :    E. Barragan   A. Chayet           

Abstract Details

Purpose:

Demonstrate how a transparent corneal inlay that changes the shape of the cornea provides a functional range of vision from near to distance, using ray-tracing to simulate clinical data.

Setting:

Institute of Ocular Microsurgery, Barcelona, Spain, Laser Ocular Hidalgo, Monterrey Mexico, CODET Vision Institute, Tijuana Mexico

Methods:

177 presbyopes were implanted with a hydrogel corneal inlay in their non-dominant eye (Raindrop Near Vision Inlay, ReVision Optics, Lake Forest, CA USA), at two clinical sites. Uncorrected ETDRS visual acuity (VA) for distance, intermediate and near, and task performance assessed using self-administered questionnaire were used as clinical outputs. The inlay-induced anterior corneal surface change was derived from the difference between postop and preop wavefront measurements, and was used in a ray-trace eye model for simulation of letter charts. The wavefront difference yields the mean axial power profile induced by the inlay.

Results:

Mean preop UNVA (logMAR) was 0.51 and by 3 months improved to 0.06. Similarly, UIVA improved 2.5 lines (0.38 preop to 0.12 at 3 months). Near task performance and near satisfaction improved after inlay implantation (p < 0.001). The axial power profile plotted as a function of the area within the pupil indicates the sub-aperture zones contributing to distance, intermediate and near visual function. Letter chart simulations confirm the visual acuity recorded clinically.

Conclusions:

Raindrop creates a gradual steepening in the central cornea (Profocal cornea), which generates a range of powers. This smooth elevation provides good near visual acuity, near task performance and patient satisfaction, while additionally improving intermediate vision and maintaining functional distance vision in the treated eye.

Financial Interest:

One or more of the authors... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented