Clinical performance of a novel modular intraocular lens system

Session Details

Session Title: Pseudophakic IOLs: Monofocal

Session Date/Time: Monday 09/10/2017 | 16:30-18:00

Paper Time: 17:29

Venue: Room 2.1

First Author: : R.Ang PHILIPPINES

Co Author(s): :    H. Uy   D. Corbett   M. Kahook              

Abstract Details

Purpose:

To report on the safety and effectiveness of the Harmoni Modular Intraocular Lens (IOL) System compared to a single piece control IOL

Setting:

Multi-center comparative clinical trial

Methods:

Eyes received the Harmoni modular IOL (HMIOL) in one eye and a standard single piece acrylic control IOL in the contralateral eye. Post-operatively, all patients underwent standard assessments, including uncorrected and best corrected visual acuity, intraocular pressure (IOP), and slit lamp examination. Specular microscopy was also performed preoperatively and during follow-up to determine endothelial cell density (ECD) loss. Additionally, HMIOL implants were photographed intra-operatively and post-operatively to assess rotational stability over the duration of follow-up. Eyes underwent anterior chamber depth (ACD) measurement with anterior segment optical coherence tomography (AS-OCT) to assess lens stability over time.

Results:

112 and 108 eyes were enrolled in the HMIOL and control IOL arms respectively. There were no statistically significant differences in preoperative demographics or baseline testing between groups. Visual acuity, IOP and ECD were similar between groups for the duration of follow-up (p>0.05). The HMIOL implants exhibited enhanced rotational stability compared to historical controls, with 97.6% of lenses rotating less than 5 degrees after 3 months of follow-up. 96% of HMIOLs, compared to 81% of control IOLs, moved less than 350um between the day of implantation and the 3-month follow-up visit (p<0.05).

Conclusions:

The HMIOL System is a safe and effective option for correcting vision in aphakic eyes. In addition, the modular system appears to offer enhanced rotational stability, along with less variability in ACD, from the day of implantation through 3 months of follow-up. Further studies are underway to validate these findings in a larger cohort of patients.

Financial Disclosure:

receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented