Complications and Management of Cosmetic Iris Implants.

OBJECTIVE

To evaluate the complications, management, and outcomes associated with cosmetic iris implants.

DESIGN

Single-center retrospective interventional case series.

SUBJECTS

30 eyes of 15 patients who presented to Moorfields Eye Hospital, London, UK with complications related to cosmetic iris implants between January 2008 and December 2023. Mean age at implantation was 34.13 ± 9.51 years, with predominantly Asian ethnicity (53%) and male gender (60%).

METHODS

Medical records were reviewed for patient demographics, pre-explantation parameters, complications, management, and outcomes. Best-corrected visual acuity (BCVA), intraocular pressure (IOP), endothelial cell count (ECC), and central corneal thickness (CCT) were analyzed before and after explantation. Secondary interventions were documented, and statistical analyses were performed using paired t-tests and Pearson correlation coefficients.

MAIN OUTCOME MEASURES

BCVA, IOP, ECC, CCT, presence of uveitis, glaucoma, corneal decompensation, cataract formation, and need for secondary surgical interventions.

RESULTS

Median time to explantation was 45.5 months (range: 6.0-140.1 months). The most common complications included uveitis (60%), elevated IOP requiring glaucoma surgery (33.3%), corneal decompensation requiring Descemet's Membrane Endothelial Keratoplasty (20%), and cataract formation requiring phacoemulsification (13.3%). A statistically significant positive correlation was found between time to explantation and corneal decompensation (r = 0.392, P = .048). In patients who underwent DMEK (n=6), ECC increased significantly from 778.33 ± 191.53 cells/mm² to 1107.33 ± 17.96 cells/mm² postoperatively (P = .009), and mean CCT decreased from 783.17 ± 293.93 µm to 508.83 ± 48.94 µm (P = .1). Despite these interventions, a considerable proportion of patients experienced persisting symptoms requiring secondary surgery.

CONCLUSIONS

This case series demonstrates that cosmetic iris implants are associated with serious sight-threatening complications including corneal decompensation, glaucoma, and uveitis. Many patients required multiple surgical interventions after explantation, highlighting the long-term morbidity associated with these devices. The authors recommend that cosmetic iris implantation should be banned worldwide given the substantial risks and lack of therapeutic value, and greater regulatory oversight is needed to prevent further harm to patients.