New Device for the Correction of Aphakia Without Capsular Support.

Area of Science:

• Ophthalmology
• Biomedical Engineering
• Medical Device Development

Background:

• Aphakia without capsular support (AWCS) presents a surgical challenge for intraocular lens (IOL) implantation.
• Existing methods for managing AWCS may have limitations in achieving stable IOL positioning.
• Novel approaches are needed to address the complexities of IOL fixation in the absence of a capsular bag.

Purpose of the Study:

• To describe a novel 3D-printed prototype device for managing aphakia without capsular support (AWCS).
• To demonstrate the proof of concept for this new AWCS management technology.
• To evaluate the feasibility and initial performance of the prototype device and its implantation technique.

Main Methods:

• Virtual prototyping using 3D software for design and analysis.
• Manufacturing of the prototype using a nylon-6/nylon-6.6 copolymer filament and a 3D printer.
• Development of a surgical implantation technique utilizing a 23-gauge hypodermic needle and specific scleral marking guidelines.
• Haptic modification involving cutting and cauterization for scleral anchoring and flange formation.

Main Results:

• Successful prototyping and development of an implantation technique for AWCS.
• No vitreous tissue extrusion observed during sclerotomy, indicating a safe initial procedure.
• The device demonstrated good initial fixation to the sclera.
• Challenges remain in achieving adequate IOL stability and centralization post-implantation.

Conclusions:

• The development of a 3D-printed technology prototype for correcting aphakia without capsular support is feasible.
• The prototype addresses several key design considerations for AWCS management.
• Further refinement is necessary to overcome challenges related to IOL stability and centralization for optimal clinical outcomes.