Refractive and Visual Outcomes of SUPRACOR TENEO 317 LASIK for Presbyopia in Hyperopic Eyes: 24-Month Follow-up

Title Page This is an Accepted Manuscript of an article published by Slack, Inc. in Journal of Refractive Surgery 35 (9), 591 – 598 on 2019, available at: https://doi.org/10.3928/1081597X-20190815-01 . It is deposited under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reuse, distribution, and reproduction in any medium, provided the original work is properly cited, and is not altered, transformed, or built upon in any way. Title Refractive and visual outcomes of SUPRACOR TENEO 317 laser-assisted insitu keratomileusis of presbyopia in hyperopia eyes: 24 months follow-up. Authors 1. Sánchez-González, José-María OD, PhD a b 2. Alonso-Aliste, Federico MD b 3. Amián Cordero, Jonatan MD b 4. Sánchez-González, María Carmen OD, PhD a 5. De-Hita-Cantalejo, Concepción OD, PhD a a Department of Physics of Condensed Matter, Optics Area. University of Seville Reina Mercedes S/N, 41012, Seville, Spain b Department of Ophthalmology (Tecnolaser Clinic Vision®). Refractive Surgery Center Juan Antonio Cavestany, 41018 Seville, Spain. Corresponding author Name: Sánchez-González, María Carmen, OD, PhD, University of Seville Address: Reina Mercedes St., Physic Faculty, University of Seville, Seville, Spain Telephone number: +34 954 55 28 91 / +34 618 20 41 10 E-mail address: msanchez7[email protected] Conflicts of Interest and Source of Funding The authors whose names are listed immediately below certify that they have no affiliations with or involvement in any organization or entity with any financial interest (such as honoraria; educational grants; participation in speakers’ bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements) or nonfinancial interest (such as personal or professional relationships, affiliations, knowledge, or beliefs) in the subject matter or materials discussed in this manuscript; Sánchez-González, José-María, Alonso-Aliste, Federico, Amián- Cordero, Jonatan, Sánchez-González, María Carmen and De-Hita-Cantalejo, Concepción. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The corresponding author is who receives reprints. 1 Clean Manuscript 1 Abstract 2 Purpose 3 PresbyLASIK surgery is based on LASIK principles and creates a multifocal cornea 4 surface that simultaneously corrects distance and near vision. The aim of our 5 retrospective study was to analyze the efficacy, safety, predictability, and stability in 6 hyperopes presbyopic LASIK surgeries with TENEO™ 317 algorithm. 7 8 Method 9 Eighty eyes from 40 patients who underwent hyperopic and presbyopic LASIK in this 10 retrospective, observational, and longitudinal study were included. All patients had a 11 24-month follow-up. Excimer laser was performed with TECNOLAS ® Perfect Vision 12 GmbH TENEO™ 317 software version 1.25 (Bausch + Lomb, Munich, Germany) with 13 the PROSCAN platform for distance dominance eye and SUPRACOR™ mild platform 14 for near dominance eye. 15 16 Results 17 Eighty eyes from 40 patients underwent TECNOLAS® Perfect Vision GmbH 18 TENEO™ 317. Mean age was 53.90 ± 4.84 (42 to 66) years. Postoperative 19 uncorrected distance visual acuity (UDVA) was 0.00 ± 0.04 (20/19.97) for the 20 dominant eye and 0.14 ± 0.05 (20/27.65) for the non-dominant eye. Postoperative 21 uncorrected near visual acuity (UNVA) was 0.51 ± 0.17 (J9) for the dominant eye 22 and 0.09 ± 0.06 (J1.5) for the non-dominant eye, while 2.5% of non-dominant eyes 23 lost 2 lines. Half of non-dominant eyes lost 1 line, and 2.5% of dominant and non- 24 dominant eyes changed 0.50 D or more between 3 and 24 months. 25 26 Conclusion 27 PROSCAN surgery in the dominant eye and SUPRACOR in the non-dominant eye 28 using the TENEO™ 317 algorithm have demonstrated that hyperope presbyopic 29 excimer laser surgery technique is effective, safe, predictable, and stable after 24 30 months of follow-up. 2 31 32 Introduction 33 In the last decade, presbyopia refractive surgery has been 1 of the most discussed 34 subjects in refractive ophthalmology. At present, there are different techniques for 35 presbyopia treatment, including intraocular lens replacement,1 intraestromal implants 36 (inlays),2 conductive keratoplasty,3 scleral expansion procedures,4 monovision 37 LASIK ,5 micro-monovision,6 contact lens,7 presbyopia drops,8 intraestromal 38 femtosecond laser treatment (IntraCOR®)9 and presbyopic laser-assisted in-situ 39 keratomileusis (PresbyLASIK).10 The IntraCOR® technique remodels the central 40 cornea by producing circular concentric intrastromal incisions with femtosecond 41 laser, preserving the epithelium.11 The term PresbyLASIK was first introduced by 42 Ruiz et al.12 and designates different multifocal corneal techniques based on a 43 LASIK procedure. There are different commercial versions of PresbyLASIK: Nidek 44 EC-5000 excimer laser (Nidek, Gamagori, Japan),13,14 VISX STAR S4 excimer laser 45 system (Abbot Medical Optics, Santa Ana, California),15 WaveLight ALLEGRETTO 46 Eye-Q (Alcon Laboratories Inc, Ft Worth, Texas),16 SCHWIND PresbyMAX 47 (SCHWIND eye-tech-solutions, Kleinostheim, Germany),17 SUPRACOR 217P, and 48 TENEO™ 317 (both Bausch and Lomb Technolas, Munich, Germany).18 49 PresbyLASIK surgery is based on LASIK principles and creates a multifocal cornea 50 surface that simultaneously corrects distance and near vision. Multifocal ablations 51 could be classified into 2 ablative profiles: central PresbyLASIK (center for near 52 vision) and peripheral PresbyLASIK (peripheral cornea for near vision).19 Central 53 PresbyLASIK creates topographical corneal profiles with a central elevation for near 54 vision and a topography flatter toward the periphery for intermediate and distance 55 vision.20 SUPRACOR® available algorithms are Technolas 217P and TENEO™ 317 56 (both Bausch and Lomb Technolas, Munich, Germany). Platforms 217P and 317 use 57 a 6-mm area; the near zone represents the central 3 mm and from 3 to 6 mm is used 58 as the peripheral zone. The main difference between 217P and 317 lies in the 59 central bump. The 217P only had a regular platform (larger bump), and 317 had mild 60 (softer bump) and regular platforms. The ablation profile algorithm was improved to 61 minimize aberration inside the pupil region.21 SUPRACOR® may be used in 1 eye or 62 both according to patient's needs and expectations.22 The aim of our retrospective 63 study was to analyze the efficacy, safety, predictability, and stability in hyperopes 64 presbyopic LASIK surgeries with the TENEO™ 317 algorithm. 3 65 66 Patients and Methods 67 Design 68 Eighty eyes from 40 patients who underwent hyperopic and presbyopic femtosecond 69 laser-assisted in-situ keratomileusis (LASIK) in this retrospective, observational and 70 longitudinal study were included. Patients underwent surgery between January 2016 71 and October 2016. All surgeries were performed at the facilities of the 72 Ophthalmology Center Tecnolaser Clinic Vision® in Seville, Spain. All patients had a 73 24-month follow-up. 74 75 Ethical aspects 76 All patients included in this work were adequately informed verbally and in writing of 77 the benefits, characteristics, and risks of the surgeries. All patients signed an 78 informed consent prior to the surgery and after the interview performed with the 79 ophthalmologist. This study was conducted in accordance with the tenets of the 80 Helsinki Declaration. The Institutional Review Board of Andalusia approved the 81 research. 82 83 Subjects 84 Forty patients (31 women and 9 men) voluntarily went to the clinic to undergo the 85 tests, and after the ophthalmologist determined their suitability for surgery, they 86 underwent hyperopic and presbyopic femtosecond LASIK surgery voluntarily. The 87 inclusion criteria were (1) age over 40 years; (2) a stable refraction for at least 1 88 year, means a change ≤ to 0.50 diopters (D) in the spherical and cylindrical 89 refraction; (3) presence of hyperopia in spherical equivalent (MSRE) between + 1.00 90 D and + 6.00 D; (4) presence of astigmatism between 0.00 D and - 1.25 D; (5) best 91 preoperative corrected visual acuity ≥ 20/25 in both eyes; (6) the maximum and 92 minimum values of the corneal curvature could not differ by more than 10 diopters; 93 and (7) a disparity ≤ 0.50 diopters in the keratometry between 2 measurements with 94 a minimum interval of 1 week. The exclusion criteria were: (8) eye diseases, such as 95 glaucoma and cataracts; (9) progressive corneal diseases, such as keratoconus or 96 presumed keratoconus and pellucid marginal degeneration; (10) pathologies on the 97 ocular surface; (11) signs of retinal vascular pathology; (12) immunodeficient 98 patients or those diagnosed with connective tissue diseases; (13) pregnant or 4 99 lactating patients; (14) patients with known sensitivity to the drugs used in the 100 standard laser refractive surgery; (15) patients with disorders of the eye muscles, 101 such as strabismus or nystagmus, or any other disorder that affects ocular fixation; 102 and (16) mate eyes without vision or amblyopia. 103 103 104 Preoperative examinations 105 Before the presbyopic surgeries, a thorough preoperative study of all patients was 106 conducted. Soft contact lens wearers had their contact lenses removed for a 107 minimum period of 2 weeks. In the case of hard lenses, the period was 4 weeks. 108 Visual examinations were performed in a full 20-foot lane; digital screen visual acuity 109 projection and photopic lighting conditions were used. Motor dominance was 110 measured with a hole-in-card test, and sensory ocular dominance was measured 111 with plus-one diopter test.23 The examination was performed by an expert 112 optometrist, and it included uncorrected and corrected visual acuity in distance and 113 near vision (decimal and Snellen scale), manifest refraction without and with 114 cycloplegia by the maximum positive refraction method. Astigmatism was assessed 115 by the Jackson cross cylinder method. These data were checked with the Wavefront 116 Supported Custom Ablation (WASCA) autorefractor-aberrometer (Carl Zeiss Meditec 117 AG, Jena, Germany). Horizontal and vertical heterophoria, near point of 118 convergence, directional and sensory dominance, and stereopsis studies were 119 completed in all patients. Corneal pachymetry, keratometry, and topography patterns 120 were measured with the Pentacam HR® single rotation Scheimpflug camera (Oculus 121 Optikgeräte GmbH, Wetzlar, Germany). Intraocular pressure and corneal 122 biomechanics were measured with CORVIS ST® (Oculus Optikgeräte GmbH, 123 Wetzlar, Germany). Epithelial thickness and retinal optical coherence tomography 124 were measured with spectral domain optical coherence tomography (SD-OCT) 125 (Optovue Inc., Fremont, CA). Finally, prior to the surgery planning, a topography was 126 performed using ZYOPTIX® ORBSCAN® II z Anterior Segment Analyzer (Bausch & 127 Lomb, Rochester, New York, USA) and ZYOPTIX® ZYWAVE® II Aberrometer 128 (Bausch & Lomb, Rochester, New York, USA). 129 129 130 Surgical technique 131 All surgeries were performed by 2 surgeons with experience in presbyopia laser 132 correction (F.A.A and J.A.C). Ten minutes prior to surgery, the eye contour was 5 133 disinfected with 5% povidone-iodine (Betadine; Meda Manufacturing, Bordeaux, 134 France). Just before the surgery, a drop of double anesthetic (tetracaine 0.1% and 135 oxybuprocaine 0.4%) (Alcon Cusí, El Masnou, Barcelona, Spain) was instilled in both 136 eyes. 137 137 138 Flap was performed with the VisuMax Femtosecond Laser System (Carl Zeiss 139 Meditec AG, Jena, Germany). The patient was placed on the table under the cone. 140 The laser was focused on the patient's pupil. The patient was asked to observe a 141 green light inside the cone. The pulses of the laser were applied with a pulse energy 142 of approximately 130 nJ. The frequency of the laser was 500 KHz. The line and spot 143 distance of each laser spot was 4.5 µm. The raster pattern was circular. The 144 estimated flap thickness was 100 µm, and the flap diameter was 8.5 mm. 145 Excimer laser was performed with TECNOLAS ® Perfect Vision GmbH TENEO™ 317 146 software version 1.25 (Bausch + Lomb, Munich, Germany) with PROSCAN platform 147 (target at 0.00, optical zone at 6.5 mm and nomogram at 100%) for distance 148 dominance eye and SUPRACOR ™ Mild platform (target from 0.00 to -0.50, optical 149 zone at 6.00 mm and nomogram at 117%) for near dominance eye. The laser type 150 was excimer pulsed argon and fluoride (ArF). The shooting frequency was 500 Hz. 151 The wavelength was 193 nm. The size of the spot was 1 mm. The shooting energy 152 was 120 mJ/cm2. 153 153 154 Postoperative evaluation 155 Patients were trained to use plastic shields though sleeping for 2 nights. Tobramycin 156 0.3% and dexamethasone 0.1% (Tobradex ®, Alcon Cusí, Barcelona, Spain) and 157 fluorometholone 0.3% (FML, Allergan, Westport, Ireland) were applied 5 times daily 158 for the first week, 3 times daily for the second week, and finally 1 time daily for the 159 third week. Patients were revised at 1 day, 15 days and 1, 3, 6, 12, and 24 months. 160 160 161 Statistical analysis 162 Statistical analysis was carried out with SPSS statistics 25.0 (IBM Corporation, 163 Armonk, NY, USA). All visual acuity data were converted into Snellen formats. The T 164 Student’s t-test was performed for parametric dependent variables. All statistical 165 tests were performed with 95% confidence levels (p < 0.05). 166 166 6 167 167 168 Results 169 Eighty eyes from 40 patients underwent TECNOLAS ® Perfect Vision GmbH 170 TENEO™ 317 software version 1.25 (Bausch + Lomb, Munich, Germany). There 171 were 31 females and 9 males. The mean age of the patients was 53.90 ± 4.84 (42 to 172 66) years. In the preoperative examination, for the dominant eye, mean sphere was 173 +1.92 ± 1.17 (0.00 to +4.50) D, mean cylinder was +0.43 ± 0.38 (0.00 to +1.25) D, 174 and mean spherical equivalent was +2.14 ± 1.14 (+0.63 to +5.00) D. For the non- 175 dominant eye; mean sphere was +2.10 ± 1.10 (+0.75 to +4.50) D (P > .05), mean 176 cylinder was +0.31 ± 0.43 (-1.25 to +1.00) D (P > .05), and mean spherical 177 equivalent was +2.26 ± 1.12 (+0.38 to +5.00) D (P > .05). Preoperative visual acuity 178 data is reported in Table 1. 179 179 180 In terms of efficacy, postoperative UDVA was 0.00 ± 0.04 (20/20) for the dominant 181 eye and 0.14 ± 0.05 (20/30) for the non-dominant eye. Binocular UDVA was 0.00 ± 182 0.04 (20/20). Postoperative UNVA was 0.51 ± 0.17 (J9) for the dominant eye and 183 0.09 ± 0.06 (J1.5) for the non-dominant eye. Binocular UNVA was 0.09 ± 0.06 (J1.5). 184 Distance cumulative Snellen visual acuity (20 / x or better) for the dominant and non- 185 dominant eyes are presented in Figure 1A and Figure 2A, respectively. Near 186 cumulative Jaeger visual acuity (Jx or better) for dominant and non-dominant eyes 187 are presented in Figure 3A and Figure 3B, respectively. Binocular cumulative visual 188 acuity (20/x or better for distance/Jx or better for near) are presented in Figure 3C 189 and Figure 3D, respectively. Regarding safety, at 24-months postoperative, 18% of 190 dominant eyes did not change CDVA lines. Eighty-three percent of dominant eyes 191 gained 1 line of CDVA (Figure 1B). 2.5% of non-dominant eyes lost 2 lines. Half of 192 non-dominant eyes lost 1 line. Finally, 48% of non-dominant eyes did not change 193 CDVA lines (Figure 2B). There were no intraoperative or postoperative 194 complications, although 2 patients needed a near enhancement in 12 months after 195 the surgery. Surgeries were performed with excimer laser in the non-dominant eye 196 with +0.25 D treatment (MEL® 80, Carl Zeiss Meditec, Germany). Near Jaeger visual 197 acuity changed from J3 to J2 in both patients. 198 198 199 For predictability, dominant and non-dominant achieved spherical equivalent 200 refraction versus attempted spherical equivalent refraction are presented in Figure 7 201 1C and 2C, respectively. The percentage of dominant and non-dominant eyes in 202 postoperative spherical equivalent refraction are presented in Figure 1D and 2D, 203 respectively. The percentage of dominant and non-dominant eyes in postoperative 204 refractive astigmatism are presented in Figure 1E and 2E, respectively. Finally, 205 among stability, the preoperative dominant eye spherical equivalent was 2.14 ± 1.13 206 D and after 24 months changed to +0.23 ± 0.37 D; 2.5% of eyes changed 0.50 D or 207 more between 3 and 24 months (Figure 1F). The preoperative non-dominant eye 208 spherical equivalent was 2.24 ± 1.15 D and after 24 months changed to - 0.24 ± 0.57 209 D; 2.5% of eyes changed 0.50 D or more between 3 and 24 months (Figure 2F). At 210 the 6th month of follow-up, 4 patients did not attend their appointment. 14 384 385 Figure Legends 386 Figure 1 – PROSCAN ® (dominant eye) standard graphs for reporting refractive 387 surgery. (A) uncorrected visual distance acuity (UDVA): efficacy histogram. (B) 388 Change in corrected distance visual acuity (CDVA): safety histogram. (C) Spherical 389 equivalent attempted versus achieved. (D) Spherical equivalent refractive accuracy. 390 (E) Refractive astigmatism. C, D, and E graphs represent predictability. (F) Stability 391 of spherical equivalent refraction. 392 Figure 2 – SUPRACOR ® (non-dominant eye) standard graphs for reporting refractive 393 surgery. (A) uncorrected visual distance acuity (UDVA): efficacy histogram. (B) 394 Change in corrected distance visual acuity (CDVA): safety histogram. (C) Spherical 395 equivalent attempted versus achieved. (D) Spherical equivalent refractive accuracy. 396 (E) Refractive astigmatism. C, D, and E graphs represent predictability. (F) Stability 397 of spherical equivalent refraction. 398 Figure 3 – Distance and near complementary visual outcomes for reporting refractive 399 surgery. (A) Near cumulative Jaeger visual acuity (Jx or better) for dominant eye. (B) 400 Near cumulative Jaeger visual acuity (Jx or better) for non-dominant eye. (C) 401 Distance binocular cumulative visual acuity (20/x or better). (D) Near binocular 402 cumulative visual acuity (Jx or better). 403 404 405 406 407 408 Table 1 Table 1. Preoperative visual acuity data logMAR scale (Snellen for distance and Jaeger for near). Uncorrected distance visual acuity (UDVA), uncorrected near visual acuity (UNVA), corrected distance visual acuity (CDVA) and corrected near visual acuity (CNVA). Visual acuity Dominant eye Non-dominant eye Binocular P value between both eyes UDVA 0.37 ± 0.19 (20/60) 0.36 ± 0.18 (20/60) 0.30 ± 0.13 (20/40) P > .05 UNVA 0.45 ± 0.28 (J11) 0.45 ± 0.28 (J11) 0.46 ± 0.15 (J8) P > .05 CDVA 0.08 ± 0.04 (20/25) 0.08 ± 0.04 (20/25) 0.00 ± 0.00 (20/20) P > .05 CNVA 0.10 ± 0.00 (J1.5) 0.10 ± 0.00 (J1.5) 0.00 ± 0.00 (J1) P > .05 Table 2 Table 2. SUPRACOR results among previous studies. Efficacy. Percentage postoperative uncorrected binocular distance and visual acuity (UDVA) (with 20/20 or better for distance / J2 or better for near distance) (Efficacy index is also shown when percentage was not available). Safety. Percentage of eyes with corrected distance visual acuity CDVA with 1 and 2 lines of loss or more (in unilateral SUPRACOR surgery, this eye data was presented). Autor Year Algorithm Eyes Eye surgery Efficacy Safety Follow up (months) Ryan and O´Keefe18 2013 217P 46 Both 48% / 73.9% 15.2% / 6.5% 6 Abreu- Lacaille et al24 2014 217P 58 Both ≈ 95% / 100% ≈ 2.5% / 0% 6 Cosar and Sener26 2014 217P 123 Both / NDE 22% / 89.4% 28.5% / 10.6% 6 Saib et al10 2015 217P 74 Both 100% / 93.1% 9.45% / 4.05% 12 Soler Tomás et al25 2015 217P 24 NDE 100% / 100% 0% / 0% 18 Ang et al22 2016 217P 69 Both / NDE 63% / 93% 12.1 % / 6.1% 6 Schlote and Heuberger21 2017 217P 39 Both 77% / 93% NR / 20% 12 NR: Not reported; DE: Dominant eye; NDE: Non-dominant eye Figure 1 Click here to access/download;Figure with Hyperlink;Figure 1 - Proscan Eye Six Graphs.tif Figure 2 Click here to access/download;Figure with Hyperlink;Figure 2 - Supracor Eye Six Graphs.tif Figure 3 Click here to access/download;Figure with Hyperlink;Figure 3. Efficacy Complementary.tiff