Aphakic IOL for Children: Multicenter Prospective Study

Trivedi, Rupal

Aphakic IOL for Children: Multicenter Prospective Study

Friday, April 25, 2014

KIOSKS (Boston Convention and Exhibition Center)

Rupal H. Trivedi, MD, Storm Eye Institute, Charleston, South Carolina, USA

M. Edward Wilson, MD, Storm Eye Institute, MUSC, Charleston, SC, USA

Narrative Responses:

Purpose
To study the outcome of the ARTISAN aphakia lens in children.

Methods
Prospective, open-label, multicenter, ongoing FDA Investigational Device Exemption (IDE) study in children between 2 to 21 years of age. N = 25 eyes of 18 children.

Results
Age at implantation: 12.0±4.7 years (4.8 to 18.4). Follow-up: median 1.0 month (0.4 to 6 months). Postoperative outcome: pupillary block, n=1; hyphema, n=1; iris atrophy 1; cell deposits on IOL: n=7. At 1-month postoperative visit, VA has remained stable/improved in 12/16 eyes with available VA data.

Conclusion
Implantation of the ARTISAN aphakic IOL in children under an FDA IDE reveals acceptable safety and visual outcomes. Monitoring is ongoing.