Research Sulcoflex Piggyback Intraocular Lens Implantation For Correction Of Refractive Errors Following Cataract Surgery Mona Purba, Associate Optometrist, Calgary, Alberta Cynthia Mardinger BHSc, Cumming School of Medicine, University of Calgary Abby Hibma BSc, Loma Linda University School of Medicine Dr. Howard V Gimbel, MD, MPH, Clinical Professor University of Calgary, Clinical Professor Loma Linda University Correspondence may be directed to: [email protected] Abstract Purpose: To investigate the visual and refractive outcomes following implantation of a Sulcoflex intraocular lens (IOL) to correct pseudophakic refractive error. Methods: This retrospective chart review included 14 pseudophakic eyes of 13 patients who underwent implantation of a Sulcoflex IOL. The Sulcoflex IOL is a piggyback IOL technique where a secondary, supplementary lens is implanted in the ciliary sulcus. Results: Eleven eyes (78.6%) had a postoperative SE within 0.50 D of the targeted SE. Preoperative UDVA was 20/30 in 4 eyes (28.6%), and 20/40 or worse in 10 eyes (71.4%). Postoperative UDVA was 20/30 or better in all eyes, where half (50.0%) of eyes were 20/20 or better. The mean preoperative logMAR (0.50 ± 0.33) significantly improved to 0.06 ± 0.09, p<.01. There were no complications. Conclusions. The significant improvement in UDVA and the precision in reaching the target refraction suggest that the Sulcoflex is a viable and successful treatment option for pseudophakic refractive error. Introduction period before capsular bag fibrosis and adhesions occur.2,3 Although today’s patients expect exact refractive results Unlike IOL exchange, the piggyback technique can be safely following cataract surgery, more than minimal residual performed at any time after cataract surgery.6,7 Piggyback IOLs refractive errors still occur in some cases.1 Current surgical also show good predictability and accuracy because the IOL treatment options for correction of pseudophakic residual power can be calculated without knowing the cause of the refractive error include: intraocular exchange (IOL) exchange, residual refractive error.1,2 Although laser refractive surgery laser refractive surgery, and implantation of a piggyback is commonly used to enhance pseudophakic refraction, it is IOL.1,2,3 The piggyback technique has classically consisted of best performed in patients with normal corneal topography the implantation of a secondary, supplementary IOL in the and a stable refractive error.8 Piggyback IOLs are an excellent sulcus or in the capsular bag anterior to the primary IOL.4,5 treatment option for patients who are not suitable candidates Recently, piggyback IOLs, such as the Sulcoflex (Rayner for laser treatment, such as those with high refractive error, a Intraocular Lenses Ltd.), have been specifically designed for history of radial or astigmatic keratotomy, as well as those with implantation in the ciliary sulcus. corneal pathologies not amenable to refractive surgery.8,9 The Removing the primary IOL can increase the risk of piggyback lens is also seen as an attractive alternative to laser incurring capsular tears and zonular damage, IOL exchange is a treatment, as it is reversible and avoids the significant corneal procedure that is best performed during the early postoperative healing that follows excimer laser ablation.1,9 20 Volume 78, Issue 2, 2016 Canadian Journal of Optometry | Revue Canadienne d’Optométrie Purba Et al. The Sulcoflex lens was the first anterior chamber piggyback on the individual’s refraction, lifestyle and needs. The IOL IOL commercially available for the correction of both spherical power and alignment was determined using Rayner’s online and astigmatic refractive errors, and can provide patients with IOL power calculator (Raytrace). near or distance vision.4,10 In addition, Sulcoflex zonal refractive multifocal IOLs are available for the correction of presbyopia Surgical Technique so as to provide patients freedom from spectacles.11,12 The One surgeon, Dr. Howard Gimbel, performed all surgeries purpose of this study was to investigate the safety and visual under topical and intracameral anesthetic. Eye-dependent and refractive outcomes following implantation of the incisions were made at variable meridians so as not to surgically Sulcoflex lens to correct pseudophakic residual refractive error induce or worsen pre-existing astigmatism. Sulcoflex IOLs were after routine cataract surgery. placed in the ciliary sulcus using the supplied injector. Good IOL centration was ensured. Toric IOLs were rotated into position Methods by exact alignment of the reference marks on the toric IOL with Study Design and Sample Recruitment corneal axis marks that were made prior to surgery. The wounds This retrospective case series investigated the outcomes of were watertight requiring no sutures. Patients were taken to patients who received implantation of a Sulcoflex IOL to the recovery room, and discharged when stable. Patients were correct residual refractive error following cataract surgery. instructed on postoperative ophthalmic medications. This study included 14 pseudophakic eyes of 13 patients that received implantation of either a Sulcoflex aspheric IOL Statistical Analysis (Rayner 653L) or a Sulcoflex toric IOL (Rayner 653T) in the Mean, standard deviation, frequency, and percentage were ciliary sulcus between October 2011 and June 2014 at the used for descriptive statistics. For visual acuity evaluation, Gimbel Eye Centre in Calgary, Alberta. Patients with previous Snellen scale values were converted to logMAR notation. radial or astigmatic keratotomy were excluded due to possible The Student paired t-test was used to compare preoperative diurnal visual fluctuations affecting the refractive outcome and postoperative UDVA. The paired t-test was also used to assessment. Patients who received implantation of Sulcoflex compare the preoperative spectacle corrected distance visual Multifocal IOLs were also excluded, as the scope of this study acuity (SCDVA) with the postoperative UDVA, as a reference was limited to refractive outcome only. Data including target indicator to the efficacy of the Sulcoflex lens implantation. refraction, preoperative refraction and uncorrected distance P-values less than 0.05 were considered statistically significant. visual acuity (UDVA) were collected. Postoperative refraction Statistical analyses were conducted using SPSS version 21. and UDVA data were collected at least 1 month after Sulcoflex implantation to ensure stability of visual outcomes. Results All participants provided informed consent for the surgical This study included 7 women and 6 men of mean age 64 years procedure, data collection and the establishment of a database. (range 49 to 82 years). Table 1 shows patient demographics, as well as the type and power of the implanted Sulcoflex IOL. IOL Model Selection and Power Calculations Of 8 aspheric and 6 toric IOLs, the mean IOL power was -0.36 The Sulcoflex is the first commercially available IOL specifically D ± 3.93 (range -9.00 to +5.00 D). The time between primary designed for secondary implantation in the ciliary sulcus.13 It surgery and Sulcoflex implantation was less than 1 year in 8 is a one-piece hydrophilic acrylic IOL that is 14mm in haptic eyes (57.1%), between 1 and 5 years in 3 eyes (21.4%), and diameter and 6.5mm in optic diameter.14 The anterior convex over 5 years in 3 eyes (21.4%), ranging from 7 months to 18 and posterior concave lens configuration allow for adequate years. Postoperative follow-up visits ranged from 1.2 months space between both IOLs, while its undulating haptics with to 14.6 months after surgery. 10° of angulation allow for adequate uveal clearance.10,13 The The mean spherical equivalent (SE) decreased from 0.16 Sulcoflex IOL is currently manufactured in aspheric, toric, and D ± 2.54 (range -5.13 to +3.00 D) preoperatively to -0.28 multifocal models. The Rayner 653L lens power is available D ± 0.60 (range -1.00 to +1.38 D) postoperatively. The from -10.00 to +10.00 D, and the Rayner 653T ranges from mean target SE was -0.15 D ± 0.21 (range -0.50 to 0.00 D). -7.00 to +7.00 D with cylinders between +1.00 to +6.00 D.14 The postoperative SE was within 0.25 D of the targeted SE in The Sulcoflex is not yet approved in Canada and was obtained 7 eyes (50.0%), 0.50 D in 11 eyes (78.6%), 0.75 D in 13 eyes with Health Canada approval. IOL types were selected based (92.9%), and had a greater than 1.00 D difference in 1 eye (7.1%). Canadian Journal of Optometry | Revue Canadienne d’Optométrie Volume 78, Issue 2, 2016 21 Sulcoflex Piggyback Intraocular Lens Implantation Table 1. Patient demographics and Sulcoflex intraocular lens (IOL) selection. Eye Age (Y) Gender IOL Type IOL Power (D) Time between primary and secondary surgery (years) 1 52 F RAY653T +0.50 0.85 2 69 M RAY653L +3.00 0.70 3 65 M RAY653L +2.50 0.81 4 56 F RAY653L +2.50 1.73 5 68 F RAY653L +3.00 0.76 6 65 M RAY653L +2.50 0.81 7 73 F RAY653L -2.00 1.30 8 75 F RAY653L -5.00 8.38 9 49 M RAY653T -4.50 0.63 10 82 F RAY653L +5.00 18.02 11 75 F RAY653T -1.00 0.94 12 53 M RAY653T +0.50 1.79 13 62 M RAY653T -3.00 0.55 14 58 M RAY653T -9.00 11.55 Table 2. Patient preoperative and postoperative refraction. Eye Preoperative Refraction Postoperative Refraction 1 +3.25 -0.50 x 67 -0.75 -0.25 x 66 2 +2.25 -0.50 x 158 0.00 -0.25 x 180 3 +2.25 0.00 x 0 plano 4 +2.00 -0.25 x 74 0.00 -0.50 x 15 5 +2.00 -0.25 x 30 +0.25 -0.25 x 50 6 +1.50 -0.25 x 146 -0.25 -0.50 x 100 7 -1.25 -1.25 x 85 -0.25 -0.25 x 65 8 -4.25 -0.75 x 52 +0.50 -1.00 x 75 9 +2.50 -2.00 x 165 +0.75 -0.50 x 133 10 +1.25 -1.00 x 67 +0.25 -0.25 x 55 11 +1.25 -2.25 x 95 -0.50 -0.50 x 48 12 +1.00 -0.50 x 50 -0.50 -0.25 x 171 13 -1.00 -1.25 x 124 +1.75 -0.75 x 89 14 -3.25 -3.75 x 4 -0.25 -0.25 x 90 Table 3.