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Optimizing the performance of RaindropTM Near Vision inlay with concurrent LASIK

Session Details

Session Title: Intracorneal inlays for correction of presbyopia

Session Date/Time: Tuesday 08/10/2013 | 08:00-10:30

Paper Time: 10:12

Venue: Main Lecture Hall (Ground Floor)

First Author: : J.Güell SPAIN

Co Author(s): :    D. Elies   A. Chayet   E. Barragan   K. Holliday   A. Lang   A.

Abstract Details

Purpose:

To provide clinical guidance, based on empirical data, for the unilateral implantation of the RaindropTM Near Vision Inlay across the -6.00 D to +3.00 D preoperative refractive range.

Setting:

Institute of Ocular Microsurgery, Barcelona, Spain

Methods:

An analysis of 177 subjects that have beenimplanted with the RaindropTM Near Vision Inlay* was performed. The RaindropTM Near Vision Inlay is a small hydrogel corneal device that is implanted in the non-dominant eye under a femtosecond laser flap and is designed to change the curvature of the overlying cornea in the pupil center, with a subsequent increase in refractive power. The Optec® 6500 Vision Tester was used to record uncorrected visual acuity(UVA) and patient self-evaluation monitored the incidence of visual symptoms, visual task performance, and satisfaction with vision. Statistical methods were employed to quantitatively compare patient outcomes across the -0.50 D to +1.75 D preoperative refractive range. Based on the results as well as clinical experience, a range of optimum preoperative refraction was isolated to maximize the performance of Raindrop. Based on the ranges of pre-op refraction that result in good near and good distance vision, the best target refraction for using the device concurrently with LASIK in the range of -6.00 D +3.00 D was determined.

Results:

Good near UVA (averaging 0.1 logMAR or better) in eyes treated only with an inlay was found to be achieved across the whole range studied. Good distance UVA (averaging 0.1 logMAR or better) in eyes treated with only an inlay was found to be achieved for subjects between about +0.25 D and +1.75 D. This very large range of pre-op acuity allowed other clinical factors to be considered. In order to minimize visual symptoms and maximize patient satisfaction, a statistical analysis found that the range of approximately +0.25 D to +1.25 D is optimum. Accounting for imprecision of ablation it was therefore concluded that the ideal target refraction for use with the Raindrop Near Vision Inlay is +0.75 D.To maximize overall visual function, it suffices to maximize the visual performance of the non-dominant and dominant eyes independently. Based on established optical and clinical principles, the dominant eye (without inlay) best target is plano-emmetropia (0.00 D).Other factors to be considered are the surgeon’s minimum ablation preference and variation in the patient’s visual performance as a function of refraction.

Conclusions:

Based on empirical data and clinical experience, the overall performance of the Raindrop Near Vision Inlay is optimized for a preoperative refraction of+0.75 D in the inlay (non-dominant) eye and 0.00 D in the fellow (dominant) eye. An ideal zone extends above and below by 0.50 D for both the inlay and fellow eyes. Subjects treated in this zone usually report very good near, intermediate, and distance UVA, nearly perfect visual task performance, and minimal incidence of visual symptoms. Each of these positive factors contributes to high patient satisfaction. When necessary, concurrent LASIK should target+0.75 D in the inlay eye and 0.00 D in the fellow eye. This optimizes patient outcomes across the full -6.00 D to +3.00 D preoperative refractive range currently treated with the Raindrop Near Vision Inlay.

Financial Interest:

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