Multicentre evaluation of visual acuity, refractive and quality-of-vision results following bilateral implantation of an intraocular lens (IOL) that can be non-invasively adjusted after implantation

Session Details

Session Title: New IOL Optic Design

Session Date/Time: Tuesday 17/09/2019 | 16:30-18:00

Paper Time: 16:36

Venue: Free Paper Forum: Podium 1

First Author: : B.Dick GERMANY

Co Author(s): :    F. Hengerer   S. Srinivasan   A. Cummings                       

Abstract Details

Purpose:

Study to compare pre-adjustment (post-implantation) and post-adjustment; visual acuity, refractive and quality of vision results of an intraocular lens (RxLAL) that can be optimized postoperatively using ultraviolet (UV) radiation. Uncorrected and best corrected visual acuity (UCDVA/BCDVA), as well as accuracy to target refraction and quality of vision were measured for all patients before and after lens adjustment.

Setting:

Study performed at Ruhr University Eye Hospital, Bochum, Germany and 3 additional European sites. Setting includes both hospital and private practices. All subjects presented with visually significant cataracts and participated voluntarily. All sites received ethics committee approvals.

Methods:

Multi-center, prospective, randomized study involving bilateral implantation of the RxLAL in 38 patients (76 eyes). All subjects received small incision phacoemulsification followed by implantation of a photoreactive, light adjustable lens. After post-op wound healing and refractive stabilization (~2-3 weeks) all eyes were refracted and underwent visual acuity (BCDVA, UDCVA) and quality of vision testing (McAlinden QOV). All subject eyes were treated with UV light to induce a targeted spherical and cylindrical refractive change. Once the desired correction was achieved, the lens was treated to prevent any further changes. Following the final treatment of the RxLAL, subjects returned for ophthalmic examinations.

Results:

38 subjects, with a mean age of 68.4 years, were implanted bilaterally with the RxLAL. Following implantation, and prior to the initial adjustment, 38.7% of study eyes achieved UCVA 20/20 or better. Post-adjustment, 76.5% of eyes achieved UCVA 20/20 or better (p<.001). 62.7% of pre-adjustment eyes were within ± 0.50 D of target MRSE, and 37.3% within ± 0.50 D of MRCYL. Post-adjustment, 85.2% were within ± 0.50 D (MRSE) and 95.1% within ± 0.50 D (MRCYL) (all values p<.001). Subjective quality of vision results showed an improvement after surgery, with low frequency of photic phenomena.

Conclusions:

The ability to adjust the light adjustable lens after surgery enables us to overcome many of the ‘prediction’ limitations of cataract surgery. The light adjustable technology was developed by Nobel prize winning chemist Robert Grubbs in 1997. While initially developed and commercialized in 2007, the product was ‘re-invented’ in 2015. This is the first reported study outcomes with the new technology, which includes proprietary injector, lens material changes, a new LDD, and additional treatment patterns. This initial study is meant to validate changes, and future studies will evaluate binocular vision techniques such as (mini-)monovision and other presbyopic solutions.

Financial Disclosure:

receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented