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    Improving the precision and consistency of scleral implant surgery

    New implant system demonstrates capacity to successfully restore or improve vision

    Take-home message: Since scleral implant surgery for presbyopia correction was first introduced, numerous enhancements have standardized and simplified the procedure. In this article, Dr Cummings discusses binocular visual improvement outcomes observed with a new generation implant system, and explains which patients may benefit from the procedue.

     

    Since scleral implant surgery for presbyopia correction was first introduced, there have been numerous enhancements in implant design, instrumentation, and technique that have standardized and simplified the procedure. The VisAbility Implant System (Refocus Group, Inc. Dallas, Texas, US) is a complete presbyopia correction that is made up of the VisAbility Implants and the VisAbility Incision System (VIS - consisting of the VIS Docking Station and VIS Sclerotome) (Figure 1).

    Next generation system for presbyopia correction

    The VIS Procedure is performed using the VIS Docking Station, which “locks” onto the sclera using four-point fixation (after conjunctival peritomy). The docking station fixes at the limbus, holds the eye steady, and eliminates the need for manual marking of the scleral tunnel sites. The VIS Docking Station serves as a guide for the disposable VIS Sclerotome so it can “dock” into position. Once the docking station is in place, the VIS sclerotome is used to create the four uniform tunnels in each quadrant of the eye, with each incision measuring 400 microns deep, 4 mm long and 4 mm from the limbus oriented tangentially. The added benefits of the disposable sclerotome are that it is easy to use (lightweight and ergonomic) and less surgeon dependent.

    Once the tunnel is created, the 2-piece PMMA implant is pulled into place by a shuttle assembly and held in place using the locking insert. The minimally invasive procedure typically takes 15-20 minutes per eye in experienced hands. In European sites tissue glue is used for hemostasis and to close and seal the conjunctiva once the implants are in place, which further increases comfort and improves recovery time. These improvements in surgical instrumentation and techniques have resulted in better tunnel consistency (location, length and depth), shorter surgical time, and quicker recovery and have standardized implantation outside the visual axis.

    Binocular improvement of near and intermediate vision

    The VIS procedure for the correction of presbyopia works in theory by increasing the space surrounding the ciliary muscle and reducing the crowding of the underlying ciliary muscle to restore effective ciliary muscle function and hence accommodation.

    In Europe, outcomes performed using the CE marked VisAbility System were analysed using data from 66 eyes (33 patients) that underwent the binocular procedure 1 month after surgery. Near distance corrected near visual acuity (DCNVA) was J3 or better in 70% of eyes (monocular) and the proportion of eyes achieving that outcome increased to 85% at 3 months, 92% at 6 months and 93% and 12 months.1

    The European VIS procedure outcomes were compared with results from eyes enrolled in the US FDA investigational device examption study, which included previous versions and earlier generation technology. In the US IDE cohort, only 63% of eyes achieved J3 or better DCNVA at 1 month and while the proportion of eyes achieving that outcome increased to 81% at 12 months, the VIS procedure showed more patients are achieving J3 or better distance corrected near visual acuity (DCNVA) sooner after their surgery (Figure 2).2 Binocular DCNVA was even better with 96% of patients in the European cohort reading J3 or better at 3 months (Figure 3).

     

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