Background: The custom-made, flexible artificial iris developed by HumanOptics and Koch can reconstruct the anterior segment of patients with aniridia. The aim of this study was to evaluate the long-term clinical outcome and complication spectrum after artificial iris implantation and the role of the embedded fiber mesh in view of specific complications.
Methods: In this retrospective interventional case series, patients received an artificial iris between 2004 and 2013. Only eyes with a minimum follow-up period of 2 years were included. Indications were congenital, traumatic, or iatrogenic aniridia. The artificial iris was used either with or without embedded fiber mesh for partial or full prostheses.
Results: We included 34 patients (mean age 48.8 years; SD ±17.2) with a mean follow-up of 50.0 months (SD ±18.9 months). No repositioning of prostheses was necessary. In cases of keratopathy (17.6 %) visual function increased from baseline mean 1.6 logMAR (SD ±0.7) to 1.2 logMAR (SD ±0.7) after artificial iris implantation. The remaining iris tissue darkened during the follow-up in 23.5 % (83.3 % with and 10.7 % without mesh), 8.8 % developed glaucoma (50 % with and 0 % without mesh) and 14.7 % needed consecutive surgery after prostheses implantation (50 % with and 7.1 % without mesh). In three out of seven trauma cases (42.9 %) silicone oil was spilled into the anterior chamber after 2.5 years on average.
Conclusion: The artificial iris prosthesis revealed a good clinical outcome in terms of long-term stability, cosmetic appearance, visual function, and represents a good functional iris diaphragm for compartmentalisation. Complications such as glaucoma, darkening of iris tissue, and need for consecutive anterior segment surgery are clearly associated with implants with integrated fiber mesh, but not to those without. Hence, the use of full iris prostheses without embedded fiber mesh, even in cases with remnant iris, and the use of slightly smaller implants than officially recommended may be beneficial.
Keywords: Aniridia; Artificial iris; Iris prosthesis.