Résumé
Objective: to assess the functional and glare outcomes as well as the safety of artificial iris (Customflex Artificial Iris) implantation. Methods: retrospective observational study of artificial iris reconstruction in 17 eyes from 16 patients with congenital aniridia or post-traumatic damage, requiring an artificial iris reconstruction between January 2023 and May 2024. All patients were examined preoperatively, at 8 days and 1, 2, 3 and 6 months postoperatively. The primary outcomes were visual acuity, refraction, complications and photophobia. Results: patients more frequently had blunt trauma (5 eyes) and penetrating injuries (10 eyes) than congenital aniridia (2 eyes from 1 patient). The iris protheses were either placed in the sulcus or fixed by transscleral suturing. Aphakia was treated, for eleven patients, with an intra ocular lens fixed at the back of the artificial iris. Three patients required keratoplasty. Monocular best corrected distance visual acuity improved from a mean of 0.92 LogMar to 0.55 LogMar (p=0.028). The spherical equivalent improved from 7.54 to -1.78 post operatively (p=0.0012). However, we noted a corneal astigmatism in patients with scleral fixations (keratotomy of 5.5 or 6 mm) from -1.22, to -3.47 (p=0.0006) because of larger incisions. Thirteen patients (76.5%) had complications but were minor for ten patients (76.9% of them). Three patients (17.6%) had severe complications. Intra-ocular pressure (IOP) did not differ between before surgery and after implantation but significantly differed between before surgery and the maximam IOP during the follow-up (p=0.001), without any repercussions on retinal nerve fiber layer thickness. Glare was significantly reduced with implantation (p=0.0003), with esthetic satisfaction by the patient. Conclusion: artificial iris implantation seems an effective and a safe option for major iris reconstructions. Complications such as hypertonia should be considered in patients at risk of post-traumatic glaucoma.