First Clinical Data on Primary Implantation of a Dedicated Pediatric Modular Intraocular Lens in Infants.

PURPOSE: To report early implantation results of a pediatric modular intraocular lens (IOL).

METHODS

This prospective cohort study included 14 consecutive eyes of 11 patients (4 boys, 7 girls) with visually significant congenital cataract who had surgery in the first year of life at a single clinical site. Intervention involved lens aspiration, IOL placement, primary pars plana posterior capsulectomy and anterior vitrectomy. A two-piece hydrophobic acrylic device composed of an 11-mm haptic and a 5.5-mm exchangeable optic disc was injected into the bag in one piece after prior ex vivo assembly.

RESULTS

Mean patient age at the time of surgery was 6.2 ± 3.0 months. On average the patients were followed up for 8.2 ± 7.9 months. Mean targeted initial refraction was 4.11 ± 1.68 diopters. The surgery was uneventful in every case. There were no intraoperative or implant-related postoperative complications. Three eyes (21%) developed retrolenticular visual axis opacification necessitating surgical clearing.

CONCLUSIONS

The dedicated pediatric modular implant demonstrated acceptable intraoperative and early postoperative safety profile. Given extraocular assembly of the study IOL, its implantation procedure is technically comparable to that of regular non-adjustable IOLs, whereas its modular design allows for future optical modification to address changing refractive status.