Keratopigmentation: A Comparative Review of Safety, Indications, and Clinical Outcomes

Throughout the years, there has been an upsurge in the quantity of cosmetic procedures aimed at changing eye color or appearance. This trend raises significant concerns about patient safety and visual health, as although many methods are promoted worldwide, their efficacy and, most importantly, safety varies greatly. This review looks at the safety of procedures that alter eye color or appearance, focusing mainly on cosmetic keratopigmentation, which is currently the only legally accepted method for changing eye color in the U.S. A review of clinical studies was conducted to evaluate the outcomes and complications related to keratopigmentation. Then, these findings were compared to other cosmetic eye procedures used internationally. Data from large clinical studies, including a retrospective analysis of 234 eyes treated with keratopigmentation, show that while many patients maintain stable vision, a notable number face complications. These issues include persistent light sensitivity, changes or fading of pigment, corneal neovascularization, limitations in visual fields, and MRI alterations. These outcomes suggest that even legally approved procedures carry risks. In contrast, more invasive cosmetic treatments like synthetic iris implants and laser iris depigmentation have been linked to much higher rates of serious complications. These problems include glaucoma, chronic uveitis, loss of endothelial cells, corneal failure, and permanent vision loss, which have led to these procedures being banned or lacking approval in the U.S. As such, it can be concluded that procedures that do not involve permanent changes inside the eye and that maintain corneal structure tend to have safer outcomes. This review concludes that among the known eye color-altering procedures, cosmetic keratopigmentation poses a lower risk but still carries significant dangers when performed with modern techniques and regulated pigments. However, the risk of serious complications emphasizes the need for careful patient selection, thorough informed consent, and better public education. Additionally, prioritizing safety in decision-making is crucial for reducing preventable vision loss in cosmetic eye treatments.