Rayner ASCRS Highlights: What Surgeons Are Saying About Rayner on the Podium

The 2015 meeting of the American Society of Cataract and Refractive Surgery (ASCRS) held in San Diego, CA, featured a number of presentations describing surgeons’ experience with Rayner’s portfolio of lenses including the C-flex, T-flex Aspheric Toric and Sulcoflex.

The Rayner Sulcoflex Pseudophakic Supplementary IOL
Correction of Residual Refractive Error
Guenal Kahraman, MD, and colleagues from the Academic Teaching Hospital of St. John, Vienna, Austria, presented long-term follow-up data of Sulcoflex implantation in pseudophakic patients with a significant residual refractive error following the primary intraocular lens (IOL) implantation.

In this prospective, non-randomized study, 45 eyes (mean age, 67.02 ± 11.1 years) received a Sulcoflex 653L to correct residual refractive error post cataract surgery. The Sulcoflex power ranged from -7.0 D to + 8.0 D; all lenses were implanted through a 2.75 mm clear cornea incision into the cilary sulcus. No intraoperative complications were observed in 43 of 45 patients; two eyes had IOL damage during the implantation (one haptic tear and one optic tear).

At a mean follow-up of 29 months (range 12 to 84 months), emmetropia or target refraction (±0.50 D) were achieved in all cases; with stable refraction during the follow-up period. The Sulcoflex lens showed high rotational stability, with no lens decentration observed. Five years post-surgery, one eye showed refraction change due to macular edema and choroidal neovascularisation associated with age-related macular degeneration. Flare values were lower than the values measured after standard cataract procedures and intraocular pressure (IOP) was within the normal range at all visits. These data indicate that the Sulcoflex IOL was well tolerated in all study eyes, and that secondary implantation of the Sulcoflex IOL in the ciliary sulcus is a safe and predictable option for patients with pseudophakic refractive errors.

Centration of Sulcus-Fixated Supplementary IOLs
Franz Prager, MD also from the Academic Teaching Hospital of St. John, Vienna, Austria, presented findings from a retrospective image analysis to assess IOL centration (capsular bag and sulcus) in cases of implantation of a sulcus-fixated supplementary IOL .

The study included 48 eyes of 43 patients. Patients had either the AMO Tecnis Z9002 (n=29, 60%), the Alcon Acrysof SN60AT/SA60AT (n=12, 25%) or the C-flex Aspheric monofocal (n=7, 15%) implanted in the capsular bag. Patients also had a sulcus-fixated supplementary IOL - either the Sulcoflex Multifocal (n=25, 52%), the Sulcoflex Aspheric (n=17, 35%) or the Sulcoflex Toric (n=6, 13%).

The analysis showed that at a mean follow-up of 25 months (range, 12 to 84 months), the mean decentration of capsular bag-fixated IOLs was 0.29mm (+/- 0.02) compared to the centre of the limbus, and 0.29mm (+/- 0.03) compared to centre of the pupil. The mean decentration of the sulcus-fixated IOL was 0.23mm (+/- 0.02) compared to the centre of the limbus and 0.22mm (+/- 0.02) compared to center of the pupil. Although both capsular bag-fixated and sulcus-fixated IOLs showed good centration and there was a statistically significant better centration of ciliary sulcus-fixated IOLs both with the limbus and the pupil when compared to the capsular bag IOLs.

Supplementary IOLs versus LASIK
In a comparative case series study, pseudophakic patients with myopic astigmatism were submitted to implantation of a supplementary IOL (n=11; Sulcoflex Aspheric 653L or Sulcoflex Toric 653T) or wavefront-guided LASIK (n=11; Technolas 217z, Bausch & Lomb Surgical). In both treatment groups, the postoperative refractive target was emmetropia.

Tiago Ferreira, MD, and colleagues showed that at 12 months postoperative, the mean uncorrected distance visual acuity (UDVA) was 0.06 ± 0.04 (Sulcoflex) and 0.06 ± 0.06 (LASIK) (p=0.817). Mean spherical equivalent (SE) refraction was -0.03 ± 0.63 (Sulcoflex) and -0.53 ± 0.90 (LASIK) (p=0.219). All eyes in the Sulcoflex group and 8 (73%) eyes in the LASIK group were within ±1.00 D of emmetropia. The mean change in SE refraction from 1 week to 12 months was 0.02 ± 0.13 D (Sulcoflex) and -0.36 ± 0.32 D (LASIK); p=003. Higher order aberrations were similar between groups, and there was no significant difference in contrast sensitivity except at 12 cpd and 18 cpd mesopic (better in the Sulcoflex group; p=0.005 and p=0.004, respectively).

These findings demonstrate that both surgical techniques provided excellent and comparable visual outcomes. However, the predictability and stability of SE correction were better in the Sulcoflex group. Overall, these data suggest that implantation of a supplementary toric IOL is a safe and effective surgical alternative for the correction of myopic astigmatism in pseudophakic patients.

The Rayner T–flex Aspheric Toric IOL
Evaluation of Contrast Sensitivity and Straylight
Khoramnia et al presented findings from an ongoing 18-eye (13 patients; mean age, 56 years) prospective study designed to evaluate straylight and contrast sensitivity following implantation of the T-flex (623T/573T).

At two and four months post-surgery, median UDVA was 0.06 logMAR (range: 0.30 to -0.18 logMAR) postoperatively and median corrected distance visual acuity (CDVA) increased from 0.20 logMAR (range: 0.64 to 0.00 logMAR) preoperatively to -0.07 logMAR (range: 0.16 to -0.26 logMAR) postoperatively. The median difference between achieved versus intended spherical equivalent was -0.08 D (range: -1.25 to +0.65 D). Median subjective cylinder improved from -2.00 D (range: -6.50 to -0.25 D) preoperatively to -0.50 D (range: -1.25 to 0.00 D) postoperatively.

Measurements of stray light (C-Quant) revealed a median value of 1.28 log(s) (range: 0.92 to 1.61 log(s)), i.e., within the normal limit; contrast sensitivity was also within the normal limit. Satisfaction with postoperative outcomes was high; 91% stated that they were satisfied with the results and would repeat surgery with the T-flex Aspheric Toric IOL.

Overall, study findings indicated that the T-flex is an effective method of correcting corneal astigmatism with good contrast sensitivity under photopic and mesopic conditions.

Visual Quality after Toric IOL Implantation
Ewa Mrukwa-Kominek MD, PhD, and colleagues presented findings from a 40 eye study (28 patients; mean age, 59.85 years) designed to assess patients satisfaction, the visual function index and rotational stability after cataract surgery followed by implantation of the T-flex Aspheric Toric IOL in patients with corneal astigmatism ≥ 1.25 D.

At a follow-up of 48-60 months, UDVA was 3.63 times better than pre-operative UDVA. With respect to CDVA, 94% and 5% of eyes gained 1 and 9 lines, respectively; whilst 1% of eyes lost 1 line of CDVA. Spectacle usage reduced by 48.1%. Refractive predictability increased from 85% (Day 1) to 95% (1 month) and a residual refractive astigmatism of 1.00 D or less was achieved in almost all eyes. There was also a significant improvement in contrast sensitivity. Overall, patient satisfaction and the visual function index were both high. Additional findings showed that the mean rotation of the T-flex was minimal and remained stable during the follow-up period; the average rotation after 6 months was 2.85˚ and less than 10˚ in 97.5% of eyes. Dr Mrukwa-Kominek added that during the follow-up period, no adhesions with the iris, no pupillary capture, and no infections were observed.

The Rayner C-flex Monofocal IOL
In Vitro Optical Bench Analysis
In a study undertaken at the International Vision Correction Research Centre, Ramin Khoramnia, MD, and colleagues analyzed the optical bench quality of the spherical and aspheric models of the C-flex IOL (570C and 970C, respectively).

The 26 D spherical C-flex and aspheric C-flex were analysed (n=10 per design) using the OptiSpheric (Trioptics) optical bench. The team evaluated the modulation transfer function (MTF) at 50 lp/mm and 100 lp/mm and the Strehl ratio using a 3 mm (photopic) and 4.5 mm (mesopic) aperture.

The analysis showed that at 50 lp/mm, the MTF values were 0.783/0.784 (C-flex 570C / C-flex 970C) for a 3 mm aperture and 0.386/0.582 for a 4.5 mm aperture. At 100 lp/mm, the MTF values were 0.613/0.606 for a 3 mm and 0.275/0.332 for a 4.5 mm aperture. The Strehl ratio was 0.909/0.914 for a 3 mm and 0.356/0.463 for a 4.5 mm aperture. The authors concluded that since differences between the aspheric and spherical design were more pronounced at mesopic conditions, patients with larger pupil sizes and/or working in mesopic conditions might benefit more from an aspheric IOL design.

Incidence of Dysphotopsia
Ashokkumar Vyas FRCS presented results from a consecutive case series of 40 eyes, designed to evaluate incidence of dysphotopsia associated with the (hydrophilic) C-flex 570C monofocal IOL..

Patients underwent a slit lamp examination one day, one week, one month and three months postoperative, and were asked to complete a questionnaire describing any visual symptoms at their one-month or three-month visit. Eighteen (45%) patients reported no ocular symptoms at their one or three month postoperative visit, and none of the 22 (55%) patients who did report visual disturbances found their symptoms debilitating. The most common post-operative visual phenomenon was glare, reported by 23% of patients; unwanted imagery was noted in 17% (7) patients. Almost all patients (98%) patients stated that they were either very satisfied or satisfied with their visual outcomes following C-flex lens implantation.

Overall, the C-flex IOL was associated with a low incidence of dysphotopsia and a high degree of satisfaction with postoperative visual outcomes. Unwanted imagery, which could be related to the lens implant, occurred in only one out of forty patients.