While iris prostheses were initially developed for managing congenital or traumatic iris defects, some ophthalmologists now offer them as an option to change the color of their patients’ eyes. However, a French study warns these cosmetic applications can cause complications in the majority of patients, including corneal decompensation, and the lenses had to ultimately be removed more than 80% of the time.

The researchers sent questionnaires to university hospital ophthalmology departments and private ophthalmologists, asking questions about demographic and clinical data for each implanted eye. Questions touched on safety, a description of ocular complications (corneal edema, endothelial cell loss, increased IOP and intraocular inflammation) and therapeutic management.

The final study included 33 questionnaires representing 65 eyes and two types of implants. Of the 65 eyes, only five (7.7%) were free of any complication, while 92.3% of eyes had at least one complication. The investigators reported the most common complication was corneal decompensation (78.5%). Additionally, the study found the diagnosis of glaucoma was made in more than half of the cases (52.3%), and responding MDs said explantation was needed in 81.5% of cases. The researchers noted the mean final visual acuity was 0.45 ± 0.08 LogMAR (0-2 LogMAR).

The retrospective study is the largest of its kind to date, the investigators wrote in their paper. “We described several ocular complications in a young healthy population with a decreased mean visual acuity,” they explained. “In addition, patient information on the safety of this procedure appeared insufficient.”