Complete depigmentation of a small aperture corneal inlay implanted for compensation of presbyopia

ABSTRACT We describe a case of late-onset remarkable depigmentation of a small aperture corneal inlay implanted for presbyopia compensation. The patient was a participant in a clinical trial designed to evaluate the safety and efficacy of the AcuFocusTM ACU-10R160, which is a 10 µm-thick polyimide film tinted with an organic dye. Inlay implantation occurred under mechanical microkeratome Lasik flaps set for a depth of 120 µm. The patient returned to the clinic 11 years after surgery and reported loss of near-vision acuity. Clinical examination showed the complete absence of pigments in the device and the total loss of the initial effect on near vision, despite normal distance vision. Manifest refraction remained stable during the follow-up period. Scheimpflug images characterized the loss of the small aperture effect on incoming light. Confocal analysis revealed small hyper-reflective round images on the endothelium and no signs of inflammation.