Safety and efficacy of custom foldable silicone artificial iris implantation: prospective compassionate-use case series

Abstract

To assess the preliminary safety and efficacy of custom silicone artificial iris implantation.Setting: Stein Eye Institute.Design: Prospective consecutive case series.Methods: Review of medical records of patients implanted with the artificial iris and followed for 1 year. Safety measures included corrected distance visual acuity (CDVA), intraocular pressure (IOP), endothelial cell count (ECC), surgical complications, secondary interventions, and adverse events (AEs). Efficacy measures included CDVA with glare, subjective daytime and nighttime glare graded from 0 to 10 (very significant), and subjective cosmetic appearance graded from 0 to 10 (very satisfied).Results: Twenty eyes (19 patients) were implanted. Safety data were mixed. CDVA improved in 13 eyes and worsened in 6. ECC decreased from 1918 ± 870 to 1405 ± 705 cells/mm 2 (P = 0.02). Eight eyes experienced postoperative complications. There were 4 IOP elevations, 2 corneal decompensations, 1 case of cystoid macular edema, and 1 device dislocation. Four eyes underwent secondary surgical interventions including 2 AEs (1 glaucoma surgery, 1 device dislocation). Efficacy outcomes were excellent. CDVA with glare improved from 1.5 ± 0.6 to 0.7 ± 0.8 logMAR (P < 0.01). Mean subjective daytime glare decreased from 8.9 ± 1.8 to 2.7 ± 2.6 (P < 0.01) and nighttime glare decreased from 7.9 ± Page 3 Custom artificial iris implantation 1.8 to 2.5 ± 2.7 (P < 0.01). Mean cosmesis improved from 2.2 ± 1.6 to 8.8 ± 2.1 (P < 0.01). Conclusion:Custom artificial iris implantation was moderately risky but very effective at reducing light and glare sensitivity and improving ocular cosmesis.

Complications of Cosmetic Artificial Iris Implantation and Post Explantation Outcomes

“…unctional prosthetic iris devices such as the Cus-tomFlex Artificial Iris (HumanOptics, Erlangen, Germany); black iris diaphragm intraocular lenses (IOLs) and modified capsule tension rings (Morcher GmbH, Stuttgart, Germany); and the iris prosthesis system and model 311 colored iris diaphragm IOLs (Ophtec BV, Groningen, the Netherlands) are designed to treat large acquired or congenital iris defects in eyes that are aphakic, pseudophakic, or cataractous. [1][2][3][4][5][6][7][8][9][10] They are not indicated for implantation into eyes with clear crystalline lenses. On the other hand, cosmetic iris devices are implanted to change iris color in healthy phakic eyes.…”

Iris reconstruction

“…A number of studies have published encouraging cosmetic and functional results with the HumanOptics CustomFlex® artificial iris including improvements in contrast sensitivity, glare, and cosmetic disturbance. [ 7 12 15 ] Furthermore, high levels of patient satisfaction have been reported. [ 7 12 ] Visual acuity outcomes are highly variable with some patients experiencing an improvement in vision,[ 16 ] others a decline,[ 15 ] and others experiencing no change.…”

“…[ 7 12 15 ] Furthermore, high levels of patient satisfaction have been reported. [ 7 12 ] Visual acuity outcomes are highly variable with some patients experiencing an improvement in vision,[ 16 ] others a decline,[ 15 ] and others experiencing no change. [ 12 ] However, it is worth noting that visual acuity outcomes are often confounded by the high prevalence of ocular comorbidities and previous trauma in study eyes.…”

“…[ 12 ] However, it is worth noting that visual acuity outcomes are often confounded by the high prevalence of ocular comorbidities and previous trauma in study eyes. [ 15 ]…”

Surgical Management for Silicone Oil Barrier of Traumatic Aniridia with Aphakia: Suturing of Temporary Iris-Diaphragm Prior to Final Iris-Lens-Diaphragm Implantation

“…The AI implantation significantly reduces the pupillary aperture and can therefore reduce the sensitivity to glare and improve contrast sensitivity. 33,34 It also provides excellent aesthetic results as it is customized to match the patient's iris tissue and as a result patient satisfaction with the functional and cosmetic result is very high. 33,[35][36][37] An advantage of this device is the fact that any commercially available artificial lens can be sutured to the posterior side of the silicone-iris.…”