Evaluation of a Novel Zonular Tension Restoring Accommodating Silicone IOL Design: Pilocarpine and Cyclopentolate-Induced Effect 20 Months after Implantation

PURPOSE: To investigate a novel zonular-stress restoring accommodating 1-piece silicone IOL. Setting. Angeles City, Philippines. DESIGN: Prospective randomized bilateral study. METHODS: Each patient received a study IOL (ActaLens™, Emmetrope, La Canada, CA) in one eye and a control IOL (CrystaLens® AO, B&L, USA, or an AcrySof IQ®, Alcon, USA) in the contralateral eye to allow for intraindividual comparison. At the 20-month follow-up, two measurement days were set to measure all eyes before and after instilling 2% pilocarpine on the first day and 1% cyclopentolate on the second measurement day using an optical biometry device (Lenstar, Haag-Streit AG, Switzerland), respectively. PCO was graded by two examiners independently at the slit lamp. RESULTS: In total, 16 eyes of 8 patients were included. In the study group and the control group, the pilocarpine-induced ACD shift was 0.32 mm (SD: 0.12) (p=0.014) and 0.04 mm (SD: 0.16) (p=0.854), respectively. In the study group and the control group, the mean cyclopentolate-induced ACD shift was 0.14 (SD: 0.06) (p=0.014) and 0.03 mm (SD: 0.03) (p=0.181), respectively. PCO and Nd : YAG rates were higher in the study group, but differences were not found to be significant (AcrySof vs. ActaLens p=0.100 and CrystaLens vs. ActaLens p=0.174). CONCLUSION: The investigated IOL is a novel concept for an accommodating IOL, and results showed a moderate pilocarpine-induced forward shift of the IOL 20 months following implantation. For all patients, the investigated IOL seems to have a higher PCO rate compared to standard monofocal IOLs.