In the past decade, refractive surgery for presbyopia has been one of the most discussed subjects in refractive ophthalmology. There are currently different techniques for presbyopia treatment, including intraocular lens replacement,1 intrastromal implants (inlays),2 conductive keratoplasty,3 scleral expansion procedures,4 monovision laser in situ keratomileusis (LASIK),5 micro-monovision,6 contact lens,7 presbyopia drops,8 intrastromal femtosecond laser treatment (IntraCOR; Technolas Perfect Vision GmbH, Munich, Germany),9 and presbyopic laser-assisted in situ keratomileusis (PresbyLASIK).10 The IntraCOR technique remodels the central cornea by producing circular concentric intrastromal incisions with the femtosecond laser, preserving the epithelium.11 The term PresbyLASIK was first introduced by Ruiz12 and designates different multifocal corneal techniques based on a LASIK procedure. There are different commercial versions of PresbyLASIK: Nidek EC-5000 excimer laser (Nidek, Gamagori, Japan),13,14 VISX STAR S4 excimer laser system (Abbott Medical Optics, Santa Ana, CA),15 WaveLight ALLEGRETTO Eye-Q (Alcon Laboratories, Inc., Fort Worth, TX),16 SCHWIND PresbyMAX (SCHWIND eye-tech-solutions, Kleinostheim, Germany),17 and SUPRACOR 217P and TENEO 317 (both Bausch & Lomb Technolas, Munich, Germany).18
PresbyLASIK surgery is based on LASIK principles and creates a multifocal corneal surface that simultaneously corrects distance and near vision. Multifocal ablations could be classified into two ablative profiles: central PresbyLASIK (center for near vision) and peripheral PresbyLASIK (peripheral cornea for near vision).19 Central PresbyLASIK creates topographical corneal profiles with a central elevation for near vision and a topography flatter toward the periphery for intermediate and distance vision.20 SUPRACOR available algorithms are Technolas 217P and TENEO 317 (both Bausch & Lomb Technolas). The 217P and 317 platforms use a 6-mm area; the near zone represents the central 3 mm and from 3 to 6 mm is used as the peripheral zone. The main difference between the 217P and 317 lies in the central bump. The 217P only has a regular platform (larger bump) and the 317 has mild (softer bump) and regular platforms. The ablation profile algorithm was improved to minimize aberration inside the pupil region.21 SUPRACOR may be used in one eye or both according to the patient's needs and expectations.22 The aim of our retrospective study was to analyze the efficacy, safety, predictability, and stability in hyperopic presbyopic LASIK surgeries with the TENEO 317 algorithm.
Patients and Methods
Eighty eyes from 40 patients who underwent hyperopic and presbyopic femtosecond laser–assisted LASIK in this retrospective, observational, and longitudinal study were included. Patients underwent surgery between January and October 2016. All surgeries were performed at the facilities of the Ophthalmology Center Tecnolaser Clinic Vision in Seville, Spain. All patients had a 24-month follow-up.
All patients included in this study were adequately informed verbally and in writing of the benefits, characteristics, and risks of the surgeries. All patients signed an informed consent prior to the surgery and after the interview performed with the ophthalmologist. This study was conducted in accordance with the tenets of the Declaration of Helsinki. The Institutional Review Board of Andalusia approved the research.
Forty patients (31 women and 9 men) voluntarily went to the clinic to undergo the tests and, after the ophthalmologist determined their suitability for surgery, underwent hyperopic and presbyopic femtosecond laser–assisted LASIK surgery voluntarily. The inclusion criteria were (1) age older than 40 years; (2) a stable refraction for at least 1 year, meaning a change 0.50 diopters (D) or less in the spherical and cylindrical refraction; (3) presence of hyperopia in spherical equivalent between +1.00 and +6.00 D; (4) presence of astigmatism between 0.00 and −1.25 D; (5) preoperative corrected distance visual acuity of 20/25 or better in both eyes; (6) the maximum and minimum values of the corneal curvature could not differ by more than 10.00 D; and (7) a disparity of 0.50 D or less in the keratometry between two measurements with a minimum interval of 1 week. The exclusion criteria were: (1) eye diseases, such as glaucoma and cataracts; (2) progressive corneal diseases, such as keratoconus or presumed keratoconus and pellucid marginal degeneration; (3) pathologies on the ocular surface; (4) signs of retinal vascular pathology; (5) immunodeficient patients or those diagnosed as having connective tissue diseases; (6) pregnant or lactating patients; (7) patients with known sensitivity to the drugs used in the standard laser refractive surgery; (8) patients with disorders of the eye muscles, such as strabismus or nystagmus, or any other disorder that affects ocular fixation; and (9) fellow eyes without vision or with amblyopia.
Before the presbyopic surgeries, a thorough preoperative study of all patients was conducted. Soft contact lens wearers discontinued wearing their contact lenses for a minimum period of 2 weeks. In the case of hard lenses, the period was 4 weeks. Visual examinations were performed in a full 20-foot lane; digital screen visual acuity projection and photopic lighting conditions were used. Motor dominance was measured with a hole-in-card test, and sensory ocular dominance was measured with a +1.00 D test.23 The examination was performed by an expert optometrist and included uncorrected (UDVA) and corrected (CDVA) distance visual acuity in distance and near vision (decimal and Snellen scale) and manifest refraction with and without cycloplegia by the maximum positive refraction method. Astigmatism was assessed by the Jackson cross-cylinder method. These data were checked with the Wavefront Supported Custom Ablation (WASCA) autorefractor-aberrometer (Carl Zeiss Meditec AG, Jena, Germany). Horizontal and vertical heterophoria, near point of convergence, directional and sensory dominance, and stereopsis studies were completed in all patients. Corneal pachymetry, keratometry, and topography patterns were measured with the Pentacam HR single rotation Scheimpflug camera (Oculus Optikgeräte GmbH, Wetzlar, Germany). Intraocular pressure and corneal biomechanics were measured with the CORVIS ST (Oculus Optikgeräte GmbH). Epithelial thickness and retinal optical coherence tomography were measured with spectral-domain optical coherence tomography (SD-OCT) (Optovue Inc., Fremont, CA). Finally, prior to the surgery planning, topography was performed using ZYOPTIX ORBSCAN IIz Anterior Segment Analyzer (Bausch & Lomb, Rochester, NY) and ZYOPTIX ZYWAVE II Aberrometer (Bausch & Lomb).
All surgeries were performed by two surgeons with experience in presbyopia laser correction (FA-A, JA-C). Ten minutes prior to surgery, the eye contour was disinfected with 5% povidone-iodine (Betadine; Meda Manufacturing, Bordeaux, France). Just before the surgery, a drop of double anesthetic (tetracaine 0.1% and oxybuprocaine 0.4%) (Alcon Cusí, El Masnou, Barcelona, Spain) was instilled in both eyes.
A flap was created with the VisuMax femtosecond laser system (Carl Zeiss Meditec AG). The patient was placed on the table under the cone. The laser was focused on the patient's pupil. The patient was asked to observe a green light inside the cone. The pulses of the laser were applied with a pulse energy of approximately 130 nJ. The frequency of the laser was 500 kHz. The line and spot distance of each laser spot was 4.5 µm. The raster pattern was circular. The estimated flap thickness was 100 µm, and the flap diameter was 8.5 mm.
Excimer laser treatment was performed with TECNOLAS Perfect Vision GmbH TENEO 317 software version 1.25 (Bausch & Lomb, Munich, Germany) with PROSCAN platform (target at 0.00, optical zone at 6.5 mm, and nomogram at 100%) for the distance dominant eye and SUPRACOR mild platform (target from 0.00 to −0.50, optical zone at 6 mm and nomogram at 117%) for the near dominant eye. The laser type was excimer pulsed argon and fluoride. The shooting frequency was 500 Hz. The wavelength was 193 nm. The size of the spot was 1 mm. The shooting energy was 120 mJ/cm2.
Patients were trained to use plastic shields while sleeping for two nights. Tobramycin 0.3% and dexamethasone 0.1% (Tobradex; Alcon Cusí) and fluorometholone 0.3% (FML; Allergan, Westport, Ireland) were applied five times daily for the first week, three times daily for the second week, and finally one time daily for the third week. Patients were observed at 1 day, 15 days, and 1, 3, 6, 12, and 24 months.
Statistical analysis was performed with SPSS statistics program version 25.0 (IBM Corporation, Armonk, NY). All visual acuity data were converted into Snellen format. The Student's t test was performed for parametric dependent variables. All statistical tests were performed with 95% confidence levels (P < .05).
Eighty eyes from 40 patients underwent treatment with TECNOLAS Perfect Vision GmbH TENEO 317 software version 1.25. There were 31 women and 9 men. The mean age of the patients was 53.90 ± 4.84 years (range: 42 to 66 years). In the preoperative examination, for the dominant eye, mean sphere was +1.92 ± 1.17 D (range: 0.00 to +4.50 D), mean cylinder was +0.43 ± 0.38 D (range: 0.00 to +1.25 D), and mean spherical equivalent was +2.14 ± 1.14 D (range: +0.63 to +5.00 D). For the non-dominant eye, mean sphere was +2.10 ± 1.10 D (range: +0.75 to +4.50 D) (P > .05), mean cylinder was +0.31 ± 0.43 D (range: −1.25 to +1.00 D) (P > .05), and mean spherical equivalent was +2.26 ± 1.12 D (range: +0.38 to +5.00 D) (P > .05). Preoperative visual acuity data are reported in Table 1.
Preoperative Visual Acuity Data logMAR Scale (Snellen for Distance and Jaeger for Near)
In terms of efficacy, postoperative UDVA was 0.00 ± 0.04 (20/20) for the dominant eye and 0.14 ± 0.05 (20/30) for the non-dominant eye. Binocular UDVA was 0.00 ± 0.04 (20/20). Postoperative uncorrected near visual acuity (UNVA) was 0.51 ± 0.17 (J9) for the dominant eye and 0.09 ± 0.06 (J1.5) for the non-dominant eye. Binocular UNVA was 0.09 ± 0.06 (J1.5). Distance cumulative Snellen visual acuities (20/x or better) for the dominant and non-dominant eyes are presented in Figure 1A and Figure 2A, respectively. Near cumulative Jaeger visual acuities (Jx or better) for dominant and non-dominant eyes are presented in Figure 3A and Figure 3B, respectively. Binocular cumulative visual acuities (20/x or better for distance/Jx or better for near) are presented in Figure 3C and Figure 3D, respectively. Regarding safety, at 24 months postoperatively, 18% of dominant eyes did not have a change in the number of lines of CDVA. Eighty-three percent of dominant eyes gained one line of CDVA (Figure 1B), 2.5% of non-dominant eyes lost two lines, 50% of non-dominant eyes lost one line, and 48% of non-dominant eyes had no change in the number of lines of CDVA (Figure 2B). There were no intraoperative or postoperative complications, although 2 patients needed a near enhancement 12 months after the surgery. Surgeries were performed with excimer laser in the non-dominant eye with +0.25 D treatment (MEL 80; Carl Zeiss Meditec AG). Near Jaeger visual acuity changed from J3 to J2 in both patients.
PROSCAN (Bausch & Lomb Technolas, Munich, Germany) (dominant eye) standard graphs for reporting refractive surgery. (A) Uncorrected distance visual acuity (UDVA): efficacy histogram. (B) Change in corrected distance visual acuity (CDVA): safety histogram. (C) Spherical equivalent attempted versus achieved. (D) Spherical equivalent refractive accuracy. (E) Refractive astigmatism. C, D, and E graphs represent predictability. (F) Stability of spherical equivalent refraction. D = diopters
SUPRACOR (Bausch & Lomb Technolas, Munich, Germany) (non-dominant eye) standard graphs for reporting refractive surgery. (A) Uncorrected distance visual acuity (UDVA): efficacy histogram. (B) Change in corrected distance visual acuity (CDVA): safety histogram. (C) Spherical equivalent attempted versus achieved. (D) Spherical equivalent refractive accuracy. (E) Refractive astigmatism. C, D, and E graphs represent predictability. (F) Stability of spherical equivalent refraction. D = diopters
Distance and near complementary visual outcomes for reporting refractive surgery. (A) Near cumulative Jaeger visual acuity (Jx or better) for dominant eye. (B) Near cumulative Jaeger visual acuity (Jx or better) for the non-dominant eye. (C) Distance binocular cumulative visual acuity (20/x or better). (D) Near binocular cumulative visual acuity (Jx or better). D = diopters; UNVA = uncorrected near visual acuity; UDVA = uncorrected distance visual acuity
For predictability, dominant and non-dominant eye achieved spherical equivalent refraction versus attempted spherical equivalent refraction are presented in Figure 1C and Figure 2C, respectively. The percentage of dominant and non-dominant eyes in postoperative spherical equivalent refraction are presented in Figure 1D and Figure 2D, respectively. The percentage of dominant and non-dominant eyes in postoperative refractive astigmatism are presented in Figure 1E and Figure 2E, respectively. Finally, regarding stability, the dominant eye spherical equivalent changed from 2.14 ± 1.13 D preoperatively to +0.23 ± 0.37 D after 24 months; 2.5% of eyes changed 0.50 D or more between 3 and 24 months (Figure 1F). The non-dominant eye spherical equivalent changed from 2.24 ± 1.15 D preoperatively to −0.24 ± 0.57 D after 24 months; 2.5% of eyes changed 0.50 D or more between 3 and 24 months (Figure 2F). At 6 months of follow-up, 4 patients did not attend their appointment.
In terms of efficacy, we found that 93% of eyes achieved 20/20 or better binocular UDVA and 90% achieved J1.5 or better binocular UNVA. Previously published studies are reported in Table A (available in the online version of this article). Thus, some authors10,24,25 found similar results to ours, whereas others18,21,22,26 reported loss of far vision. Authors with the worst results performed bilateral SUPRACOR surgeries, whereas authors who performed SUPRACOR surgery in the non-dominant eye and adjusted the manufacturer's nomogram obtained better results. We can confirm that dominant eye corneal central steepening induces myopia. This myopia affects distance vision. In this sense, Cosar and Sener26 performed bilateral surgery in the first 55 patients. After that, they changed the methodology and only performed SUPRACOR surgery in the non-dominant eye.
SUPRACOR Results Among Previous Studies
In terms of safety, our results showed 50% of non-dominant eyes lost one line. Previously published studies are reported in Table A. Our results showed 2.5% of non-dominant eyes lost two lines of CDVA. These results matched those published by other authors; Abrieu-Lacaille et al.24 and Soler Tomás et al.25 found that no patients lost two lines or more.
In terms of predictability, our results were 1.08 × 0.41 (R2 = 0.91) for the dominant eye (PROSCAN) and 0.98 × +0.17 (R2 = 0.93) for the non-dominant eye (SUPRACOR). Most of the authors who performed SUPRACOR 217P surgery did not present the predictability in terms of a regression line between the attempted and achieved refraction. Poor predictability for SUPRACOR surgery was obtained by Ryan and O' Keefe18 (y = 0.56 × +1.04) and Ang et al.22 (y = −0.54 × 0.56). Both studies used bilateral surgeries. In addition, Ang et al.22 achieved two additional groups in which 1 eye was treated with SUPRACOR surgery and the contralateral eye with hyperopic LASIK and a third group in which only one SUPRACOR surgery was performed on the non-dominant eye. The presentation of predictability is in a single chart for all cases without distinguishing between groups or between the plano target for the dominant eye and negative target for the non-dominant eye. Therefore, comparing predictability results with other authors is tricky. Our results showed good predictability and a regression coefficient greater than 0.90 for both eyes, separately. Regarding the spherical equivalent obtained, our results showed 65% of SUPRACOR surgeries within ±0.50 D and 93% within ±1.00 D. Ryan and O'Keefe18 reported 54% within ±0.50 D and 83% within ±1.00 D, and Ang et al.22 found 68% within ±0.50 D and 94% within ±1.00 D. These results are conditioned by the corneal multifocality. Central PresbyLASIK, such as SUPRACOR, increases the corneal multifocality,19,27 and therefore the postoperative spherical equivalent and residual astigmatism were greater than non-multifocal surgery without central elevation.6,15,28
In terms of stability, our results showed a change of +0.22 D from 3 (−0.46 D) to 24 (−0.24 D) months of follow-up for the non-dominant eye with SUPRACOR surgery, but the change was +0.39 D in the dominant eye with PROSCAN surgery. The mean spherical equivalent changed from −0.16 D at 3 months of follow-up to +0.23 D at 24 months of follow-up. Ryan and O'Keefe,18 Abrieu-Lacaille et al.,24 Cosar and Sener,26 and Ang et al.22 had a short-term follow-up, whereas other studies reported a postoperative follow-up of 12 and 18 months. Among them, Saib et al.10 reported a change of +0.50 D in the dominant eyes. The mean spherical equivalent changed from −0.25 D at 3 months of follow-up to +0.25 D at 24 months of follow-up. Soler Tomás et al.25 reported both dominant and non-dominant eyes together with a change of +0.30 D. The mean spherical equivalent changed from −0.40 D at 3 months of follow-up to −0.20 D at 24 months of follow-up. Finally, Schlote and Heuberger21 did not report the change in the spherical equivalent. Although the number of studies that can be compared is scarce, all of the authors showed results similar to ours, which shows the slight regression that occurs. Epithelium cellular changes influence postoperative visual regression following hyperopic LASIK.29 It is necessary to achieve a long-term follow-up of these patients.
PROSCAN surgery in the dominant eye and SUPRACOR in the non-dominant eye using the TENEO 317 algorithm demonstrated that the hyperopic presbyopic excimer laser surgery technique outcomes are reasonable after 24 months of follow-up. The results obtained improve the existing ones for bilateral SUPRACOR surgeries with the 217P algorithm. A greater volume of patients and a long-term follow-up is essential to confirm the reported results.
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Preoperative Visual Acuity Data logMAR Scale (Snellen for Distance and Jaeger for Near)
|Visual Acuity||Dominant Eye||Non-dominant Eye||Binocular||P|
|UDVA||0.37 ± 0.19 (20/60)||0.36 ± 0.18 (20/60)||0.30 ± 0.13 (20/40)||> .05|
|UNVA||0.45 ± 0.28 (J11)||0.45 ± 0.28 (J11)||0.46 ± 0.15 (J8)||> .05|
|CDVA||0.08 ± 0.04 (20/25)||0.08 ± 0.04 (20/25)||0.00 ± 0.00 (20/20)||> .05|
|CNVA||0.10 ± 0.00 (J1.5)||0.10 ± 0.00 (J1.5)||0.00 ± 0.00 (J1)||> .05|
SUPRACOR Results Among Previous Studies
|Author||Year||Algorithm||Eyes||Eye Surgery||Efficacya||Safetyb||Follow-up (Mo)|
|Ryan & O'Keefe18||2013||217P||46||Both||48%/73.9%||15.2%/6.5%||6|
|Abreu-Lacaille et al.24||2014||217P||58||Both||∼95%/100%||∼2.5%/0%||6|
|Cosar & Sener26||2014||217P||123||Both/NDE||22%/89.4%||28.5%/10.6%||6|
|Saib et al.10||2015||217P||74||Both||100%/93.1%||9.45%/4.05%||12|
|Soler Tomás et al.25||2015||217P||24||NDE||100%/100%||0%/0%||18|
|Ang et al.22||2016||217P||69||Both/NDE||63%/93%||12.1%/6.1%||6|
|Schlote & Heuberger21||2017||217P||39||Both||77%/93%||NR/20%||12|