New Device for the Correction of Aphakia Without Capsular Support.

Purpose: This study describes a prototype developed for aphakia without capsular support (AWCS) and its proof of concept.

Methods: This descriptive study used a 3D software to create and analyze virtual prototypes before manufacturing. A nylon-6/nylon-6.6 copolymer filament and a 3D printer were used for prototyping. A device implantation technique was developed using a 23-gauge hypodermic needle. Two opposing markings, 2 mm posterior to the limbus, were made to determine the location of the scleral punctures and the final position of the device. After adequate centralization and positioning of the device, its haptics were cut and cauterized to generate thermal modeling of the extremity and allow the thickening of the tips (flange), serving as an anchoring mechanism to the sclera. The efficacy and adequacy of the technique and device were then evaluated.

Results: Vitreous tissue extrusion was not observed during the sclerotomy. The device was well fixed to the sclera; however, adequate IOL stability and centralization still needed to be achieved. The surgeon evaluated the adequacy of all the other devices' characteristics.

Conclusions: The development of a technology prototype for correcting AWCS was possible. Although the proposed prototype met most of the established concept guidelines, the stability of the IOL position remains challenging.