Revolutionary, not evolutionary: early results of subjects implanted with the Model SC9 intraocular lens (CORD LLC, Cumming Ophthalmic Research and Development)

Session Details

Session Title: New IOLs: Material & Preload IOL

Session Date/Time: Monday 24/09/2018 | 08:00-10:30

Paper Time: 08:39

Venue: Room A3, Podium 2

First Author: : A.Aker USA

Co Author(s): :    J. Rodilla                    

Abstract Details

Purpose:

Several surgical options for correcting presbyopia while maintaining distance vision in subjects who have had cataract surgery have been evaluated with varying degrees of success. Multifocal and Extended Depth of Focus lenses have been associated with unwanted visual symptoms and the accommodating intraocular lens has shown to be unpredictable in some cases. This new lens design, the Model SC9, a single focus optic has been designed to reduce or eliminate the need for corrective lenses after cataract surgery with minimal visual symptoms.

Setting:

Aker Kasten Eye Center, Private Practice, Boca Raton, Florida. USA

Methods:

Thirty-one subjects signed an informed consent prior to pre-operative testing to determine their eligibility to be enrolled into a multicenter clinical study. Cataract surgery was performed with manual phacoemulsification. At the time of implantation, BCDVA was worse than 0.2 LogMAR (20/32) with or without a glare source. Corneal Astigmatism was less than 1 diopter, subjects were targeted closest to emmetropia. To determine the lens power, the SRK-T formula was selected for eyes with an axial length longer than 22.0 mm. The Holliday formula was used for eyes measuring less than 22.0mm. Lens powers ranged from 18.D to 25.5D.

Results:

Post-operatively visual acuity was tested using the Optec 6500 Vision tester, luminance calibrated at 85cdm2. At the 1-day post-operative visit UCDVA was 20/40 or better in 28/31 subjects (91%), UCIVA and UCNVA was 20/40 (J3) or better in 23/31 subjects (74%). At the 1-week post-operative visit UCDVA was 20/25 or better in all subjects (100%) and UCIVA was 20/32 or better in 27/31 (88%) and UCNVA was J2 or better in 26/31 (83%). In this group, one subject had CME which resolved, one subject reported mild glare at 1 week. No reports of CCS, lens tilt, or vaulting.

Conclusions:

Although early, these excellent FDA phase 1 preliminary results confirm the extended depth of focus design, The Model SC9 consistently locates posteriorly closest to the nodal point acting like a virtual pin hole. The unique patented design enables subjects to have a full range of vision at all distances with no significant visual symptoms. Additionally, the Model SC9 design is confirmed by demonstrating depth of focus through depth of focus testing from +1.00 to -5.00D. Of interest, cycloplegia had no effect on uncorrected visual acuities. Visual acuities were the same with or without cycloplegia.

Financial Disclosure:

... has significant investment interest in a company producing, developing or supplying product or procedure presented, ... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented