The effective treatment of presbyopia has proven to be a significant challenge to refractive surgeons. In the aging western population, its prevalence constantly increases and presbyopia correction procedures continue to gain popularity. There are several approaches to the correction of presbyopia: varifocal or bifocal contact lens or glasses and surgical techniques including the implantation of accommodating or multifocal intraocular lenses.1–3 Scleral expansion procedures,4 monovision refractive correction,5,6 inlays,7,8 intrastromal femtosecond laser treatment,9 and presbyopic LASIK (presbyLASIK) are among some of the corneal techniques. A corneal approach is attractive to many surgeons because it is the least invasive, avoiding the potential risks for an intraocular procedure.
The concept of multifocal presbyLASIK is attractive because it uses a well-known surgical technique, LASIK. There are a variety of presbyLASIK procedures. Either a central area hyperpositive for near vision is created, leaving the mild peripheral cornea for distance vision (central presbyLASIK),10–15 or a central area for distance vision is created with a mid-peripheral corneal area for near vision (peripheral presby-LASIK).16–21 However, there is always a compromise between the optical distance and near vision achieved, which often results in undesired aberrations in the pupil region. An aberration-optimized presbyopic algorithm called SUPRACOR (Technolas Perfect Vision GmbH, Munich, Germany) has been developed to treat presbyopia. This excimer laser has been designed to provide a presbyopic correction while minimizing the induction of unwanted aberrations within the pupil region with the knowledge from the intrastromal treatment.
The purpose of our study was to evaluate the visual and refractive outcomes of the SUPRACOR multifocal corneal LASIK procedure for the correction of hyperopia and presbyopia using a micro-monovision protocol.
Patients and Methods
This study was a retrospective, interventional case series including 74 consecutive eyes of 37 presbyopic patients with hyperopia treated with the SUPRACOR multifocal excimer LASIK procedure between June 2011 and March 2014 at the Percy Hospital, Ophthalmology Department, Clamart, France.
Inclusion criteria were a manifest refraction spherical equivalent (MRSE) between +1.00 and +3.50 diopters (D), astigmatism of 1.00 D or less, a cycloplegic refraction of 0.50 D close to the MRSE, mean keratometry readings between 41.00 and 45.00 D, age 46 years or older, a required near addition between +1.75 and 2.50 D, a corrected distance visual acuity (CDVA) in each eye of 20/25 or better, a central corneal thickness of 500 µm or greater, a mesopic pupil between 3 and 6 mm, a kappa angle less than 8°, and no visually significant cataract. Exclusion criteria were the presence of ocular surface disease, clinically significant corneal opacity and abnormal corneal topography, and any signs of binocular vision anomalies at distance or near.
Informed consent and permission to use the patient’s data for analysis and publication were obtained from each patient. Institutional review board approval was not obtained because this was an interventional study and did not include investigational treatments for human subjects.
All patients had a full ophthalmologic examination before surgery, including manifest refraction, cycloplegic refraction, slit-lamp microscopy of the anterior segment, dilated funduscopy, and intraocular pressure measurement. The preoperative examination also included corneal topography with the Orbscan IIz system (Technolas Perfect Vision GmbH) and Pentacam (Oculus Optikgeräte, Wetzlar, Germany). Wavefront aberrometry measurements were obtained with the Zywave II aberrometer (Technolas Perfect Vision GmbH) with undilated pupils preoperatively and pupillometry. The uncorrected distance visual acuity (UDVA) and CDVA were measured on a logMAR chart monocularly and binocularly. The uncorrected near visual acuity (UNVA) was recorded as the smallest print the patient could read comfortably on the Parinaud reading test at 33 cm without correction.
Ocular Dominance Testing
Ocular dominance was assessed using two methods: the “hole test” and pointing to determine which eye was used for sighting a camera and a rifle. The “hole test” involved the patient binocularly aligning a distant object through a hole in a plain A4 sheet of paper. The eyes were alternately covered while looking through the hole. The eye with which the object appeared most centered through the hole was deemed to be the dominant eye.
All surgeries were performed by the same surgeon (J-CR-S) using the Technolas 217P excimer laser (Technolas Perfect Vision GmbH). Superior-hinged corneal flaps of 120-µm thickness and 9- to 9.2-mm diameter were created with the IntraLase FS60 femtosecond laser (Abbott Medical Optics, Abbott Park, IL). The ablation was performed using the Technolas excimer 217P laser with the SUPRACOR Regular algorithm centered over the center of the pupil. Dynamic rotational eye tracking using Zyoptix ACE technology (Technolas Perfect Vision GmbH) and iris recognition were used during the ablation. The SUPRACOR Regular algorithm created a hyperpositive area in the central 3-mm zone. Both eyes were treated by the SUPRACOR Regular algorithm. There was a distinction between dominant eyes and non-dominant eyes in the treatment calculation with the nomogram (Figure A, available in the online version of this article) and a micro-monovision of −0.50 D was induced.
Nomogram for (1) dominant eye and (2) non-dominant eye.
The postoperative topical regimen was Tobradex (Alcon Laboratories, Inc., Fort Worth, TX) four times daily for 8 days and topical hyaluronic acid 0.1% four times daily for 15 days.
Patients were reviewed at 1 and 7 days, 1, 3, and 6 months, and 1 year after surgery. All postoperative follow-up visits included measurement of monocular and binocular UDVA and UNVA. Manifest refraction, CDVA, and CNVA were obtained at all postoperative visits. Corneal topography and aberrometry were performed postoperatively at 6 months. Due to the pupil size restriction for the multifocal treatment eligibility, Zernike values were obtained with a 5-mm pupil. Patient satisfaction was assessed by questionnaire 6 months postoperatively. Patients were asked the following questions: (1) Are you happy you had the procedure performed? (yes, moderate, no); (2) Do you have a better quality of life? (yes, moderate, no); (3) Do you need reading glasses to read the newspaper or small package inserts or labels? (yes, sometimes, never); (4) Do you need glasses for intermediate vision for the computer? (yes, sometimes, never); (5) Do you need glasses for distance vision (car, television)? (yes, sometimes, never); and (6) Do you recommend this surgery for your friends? (yes, no).
Aberrations were compared preoperatively and postoperatively using the paired Student’s t test. A P value less than .05 was considered significant.
Seventy-four eyes of 37 patients were treated. The mean age was 54 ± 4 years (range: 46 to 63 years). There were 20 women and 17 men. The mean preoperative MRSE was 1.48 ± 0.55 D (range: +0.50 to +3.50 D), mean sphere was 1.75 ± 0.56 D (range: 0.75 to 2.75 D), and mean cylinder was −0.51 ± 0.36 D (range: 0.00 to −1.00 D). Mean preoperative monocular UDVA was 0.38 ± 0.25 logMAR (Snellen 20/47) and UNVA was Parinaud 6 (Jaeger 5). Mean spectacle near addition was 2.04 ± 0.43 D (range:1.50 to 2.50 D).
Sixty-six eyes of 33 patients completed 6 months of follow-up and 48 eyes of 24 patients completed 12 months of follow-up.
The mean binocular UDVA was 0.06 ± 0.09 logMAR (Snellen 20/22) at 3 months, 0.01 ± 0.10 logMAR (Snellen 20/20) at 6 months, and −0.01 ± 0.05 logMAR (Snellen 20/19) at 1 year. Binocularly, 93.10% of patients achieved 20/25 or better at 6 months and 100% of patients achieved 20/25 or better at 1 year (Figure 1A).
(A) Cumulative binocular uncorrected distance visual acuity, (B) cumulative binocular uncorrected near visual acuity, and cumulative monocular visual acuity for the (C) dominant and (D) non-dominant eye.
For the dominant eye, the mean monocular UDVA was 0.16 ± 0.19 logMAR (Snellen 20/28) at 3 months, 0.07 ± 0.13 logMAR (Snellen 20/23) at 6 months, and 0.045 ± 0.10 logMAR (Snellen 20/22) at 1 year. Of the dominant eyes, 83.33% achieved uncorrected visual acuity of 20/25 or better at 6 months and 90% achieved 20/25 or better at 1 year (Figure 1C).
For the non-dominant eye, the mean monocular UDVA was 0.325 ± 0.22 logMAR (Snellen 20/41) at 3 months, 0.17 ± 0.16 logMAR (Snellen 20/29) at 6 months, and 0.05 ± 0.10 logMAR (Snellen 20/22) at 1 year. Of the non-dominant eyes, 48.38% achieved uncorrected visual acuity 20/25 or better at 6 months and 80% achieved 20/25 or better at 1 year (Figure 1D).
The mean UNVA was 0.17 ± 0.15 logMAR (Snellen 20/29) at 3 months, 0.18 ± 0.14 logMAR (Snellen 20/30) at 6 months, and 0.18 ± 0.12 logMAR (Snellen 20/30) at 1 year. Binocularly, 86.2% of patients achieved UNVA of Parinaud 2 (Jaeger 1) or better and 93.1% could read Parinaud 3 (Jaeger 2) at 6 months. At 1 year, 84.21% of patients could read Parinaud 2 (Jaeger 1) or better and 94.73% could read Parinaud 3 (Jaeger 2) or better (Figure 1B).
For the dominant eye, the mean UNVA was 0.20 ± 0.19 logMAR (Snellen 20/31) at 3 months, 0.26 ± 0.18 logMAR (Snellen 20/36) at 6 months, and 0.27 ± 0.19 logMAR (Snellen 20/37) at 1 year. For the dominant eyes, 55.5% could read Parinaud 2 (Jaeger 1) or better and 63.1% could read Parinaud 3 (Jaeger 2) or better.
For non-dominant eyes, the mean UNVA was 0.18 ± 0.16 logMAR (Snellen 20/30) at 3 months, 0.20 ± 0.14 logMAR (Snellen 20/31) at 6 months, and 0.19 ± 0.11 logMAR (Snellen 20/30) at 1 year. Of the non-dominant eyes, 83.8% could read Parinaud 2 (Jaeger 1) or better and 95% could read Parinaud 3 (Jaeger 2) or better.
Binocular UDVA Versus UNVA
At 6 months postoperatively, simultaneous distance and near visual acuity of 20/25 UDVA and Parinaud 2 (Jaeger 1) UNVA was achieved in 79.31% of patients, whereas 20/25 UDVA and Parinaud 3 (Jaeger 2) UNVA was achieved in 86.20% of patients (Figure 2A).
Bar graphs showing cumulative postoperative binocular uncorrected visual acuities (A) 6 months and (B) 1 year after presbyopic corneal treatment using Technolas 217P with the SUPRACOR Regular module (Technolas Perfect Vision, GmbH, Munich, Germany).
At 1 year postoperatively, simultaneous distance and near visual acuity of 20/25 UDVA and Parinaud 2 (Jaeger 1) UNVA was achieved in 84.21% of patients, whereas 20/25 UDVA and Parinaud 3 (Jaeger 2) UNVA was achieved in 94.73% of patients (Figure 2B).
Spherical Equivalent Refraction
At 6 months, MRSE was −0.00 ± 0.58 D for dominant eyes and −0.51 ± 0.54 D for non-dominant eyes. There was a myopic shift in the first months postoperatively, which decreased in the following 6 months. The micro-monovision of −0.50 D was always respected (Figure 3).
Spherical equivalent refraction after the treatment of the (A) dominant eye and (B) non-dominant eye.
A total of 9.45% of patients lost one line of CDVA and 4.05% of patients lost two or three lines of CDVA at 6 months. No patient lost more than three lines of CDVA.
Central Steep Zone
The central steep zone was measured by difference of corneal topography between preoperative and postoperative values within the central 3-mm steep zone. The mean central steep zone was 2.35 ± 1.00 D (range: 0.70 to 4.80 D) (Figure B, available in the online version of this article).
The central steep zone was the difference of corneal topography between postoperative and preoperative in Pentacam (Oculus Optikgeräte, Wetzlar, Germany) within the central 3 mm.
Ideally, aberration measurements are compared with equally sized pupils (eg, 6 mm). In the current study, Zywave II aberrometry readings were taken under identical lighting conditions in the same room. Pupil sizes were randomly distributed, but not all reached 6 mm. There was no statistical difference between pupils preoperatively at 5.83 ± 0.79 mm and postoperatively at 5.81 ± 0.65 mm (P > .05) for dominant eyes and at 6.03 ± 0.42 and 5.80 ± 0.87 mm, respectively, for non-dominant eyes (P > .05). The median higher-order aberrations root mean square in the central 5 mm increased from 0.30 ± 0.12 µm preoperatively to 0.43 ± 0.13 µm postoperatively for dominant eyes (P < .05) and from 0.30 ± 0.10 to 0.48 ± 0.12 µm for non-dominant eyes (P < .05). Spherical aberration changed from +0.21 ± 0.12 to −0.06 ± 0.11 µm for dominant eyes (P < .05) and from +0.21 ± 0.14 to −0.14 ± 0.18 µm for non-dominant eyes (P < .05). Vertical coma changed from +0.04 ± 0.19 to −0.31 ± 0.23 µm for dominant eyes (P < .05) and from +0.05 ± 0.19 to −0.31 ± 0.28 µm for non-dominant eyes (P < .05). Vertical trefoil changed from −0.08 ± 0.20 to +0.02 ± 0.23 µm for dominant eyes (P > .05) and from −0.08 ± 0.18 to 0.03 ± 0.20 µm for non-dominant eyes (P > .05). Horizontal trefoil did not significantly change from −0.02 ± 0.11 to −0.02 ± 0.12 µm for dominant eyes (P > .05) and from −0.03 ± 0.15 to +0.039 ± 0.17 µm for non-dominant eyes (P > .05). Horizontal coma did not significantly change from +0.005 ± 0.15 µm to −0.04 ± 0.17 µm for dominant eyes (P > .05) and from −0.09 ± 0.16 to +0.07 ± 0.24 µm for non-dominant eyes (P > .05) (Table A, available in the online version of this article). There was no statistical difference concerning the aberrations between the dominant and non-dominant eyes.
An incomplete side cut occurred perioperatively, but it was manually finished with no complication. One patient had significant dryness and was treated by cyclosporine.
Patient satisfaction was assessed through a subjective questionnaire. A total of 83.3% of patients reported that they were independent from reading glasses all of the time, 10% used them sometimes, and 6.7% were still dependent on reading glasses all of the time. Ninety percent of patients reported that they were independent from glasses for intermediate vision and 10% needed them sometimes. A total of 83.3% of patients reported that they were independent from glasses for distance vision, 10% needed them sometimes, and 6.7% needed them all of the time. A total of 96.7% of patients said they had a better quality of life and 3.3% had a moderate improvement in quality of life. Regarding satisfaction, 83.3% of patients were happy to have this procedure, 16.7% were moderately happy, and none were disappointed. All of the patients (100%) would recommend this procedure to their friends.
Five patients (13.51%) had a re-treatment in only one eye. No patient who underwent re-treatment received bilateral treatment. The re-treatment rate was 6.75% (5 of 74 eyes). All re-treatments were done by LASIK tissue saving. One patient had a re-treatment of +1.00 D in the non-dominant eye to improve near vision at 10 months after the SUPRACOR treatment. Two patients had a retreatment in the dominant eye to improve distance vision. The mean re-treatment spherical equivalent was −2.00 D for the first procedure and −1.00 D for the second procedure. Two patients had a re-treatment in the non-dominant eye to improve distance vision. The mean re-treatment spherical equivalent was −1.00 D for the first procedure and −2.00 D for the second procedure. The mean delay time of myopic re-treatment was 2.3 months after the SUPRACOR treatment. Four patients achieved 20/20 and Parinaud 2 (Jaeger 1) binocularly and 1 patient achieved 20/25 Parinaud 1.5 (Jaeger 1+) binocularly after the re-treatment. One patient had a little peripheral epithelial ingrowth after the re-treatment.
Patients Older Than 55 Years
In our study, 18 patients were older than 55 years. The mean age of this subgroup was 58.8 ± 2.1 years (range: 56 to 63 years). Thirty-five eyes of 17 patients completed 6 months of follow-up and 26 eyes of 13 patients completed 12 months of follow-up.
The mean binocular UDVA was 0.06 ± 0.08 logMAR (Snellen 20/22) at 3 months, −0.006 ± 0.05 logMAR (Snellen 20/17) at 6 months, and 0.01 ± 0.05 logMAR (Snellen 20/20) at 1 year. The mean UNVA was 0.18 ± 0.21 logMAR at 3 months, 0.22 ± 0.18 logMAR at 6 months, and 0.18 ± 0.14 logMAR at 1 year. At 6 months postoperatively, 85.8% achieved 20/25 or better and Parinaud 3 (Jaeger 2) or better. At 1 year, 90% achieved 20/25 or better and Parinaud 3 (Jaeger 2) or better. The central steep zone was 2.40 ± 0.21 D in this subgroup.
There was no statistical difference among all patients and patients older than 55 years concerning aberrations. There was no statistical difference found concerning aberrations between patients older than 55 years and patients younger than 55 years (Table A).
In this subgroup, 91% of patients reported that they were independent from reading glasses all of the time and 8.33% still needed reading glasses all of the time. All patients (100%) reported that they were independent from glasses for intermediate vision. For distance vision, 91.6% reported that they were independent from glasses and 8.4% needed glasses sometimes. Regarding patient satisfaction, 75% of patients were happy to have benefited from this procedure, 25% were moderately happy, and none were disappointed. All patients (100%) said they had a better quality of life. The re-treatment rate was 8.33% (3 of 36 eyes).
McDonnell et al.22 found that useful near vision can result from changes in corneal multifocality following a corneal refractive surgical procedure in cases undergoing myopic correction by radial keratotomy. The first successful intentional creation of a multifocal ablation profile designed to correct myopic refractive error and maintain good uncorrected near vision was reported by Moreira et al.23 Currently, there are two techniques capable of creating a multifocal cornea using a LASIK procedure: central presbyLASIK and peripheral presbyLASIK. Alió et al.24 used central presbyLASIK and reported that 64% of patients achieved a UCVA of better than 20/20 and 72% of patients achieved a near UCVA of better than 20/40 after 6 months. They reported a loss of two lines of CDVA for distance in 14% of patients. Pinelli et al.25 used peripheral presbyLASIK and reported mean binocular UCVA was 1.06 ± 0.13 for distance and 0.8 ± 0.14 for near 6 months postoperatively; 4.5% of eyes lost one line of CDVA for distance.
SUPRACOR is a corneal approach to treat hyperopic presbyopia. We induced micro-monovision with the Technolas excimer workstation 217P. Ryan and O’Keefe26 reported 91% of patients had a binocular UDVA of 0.2 logMAR or better and 91% had an uncorrected reading ability of N8 or better at 6 months postoperatively; their re-treatment rate was 22%. Cosar and Sener27 reported UDVA was 20/20 or better in 22% eyes and UNVA was 20/20 or better in 77.2% at 6 months postoperatively. In our study, 93.10% of patients had a binocular UDVA of 20/25 or better for distance at 6 months postoperatively, and 100% of patients had a UDVA of 20/25 or better at 1 year. For near vision, 86.2% of patients had a UNVA of Parinaud 2 (Jaeger 1) or better for near vision at 6 months and 84.2% of patients had a UNVA of Parinaud 2 (Jaeger 1) or better at 1 year. We had better results with the same algorithm (SUPRACOR Regular), probably because we included micro-monovision to improve the compromise between the distance and near vision.
There are few studies of hyperopic monovision. Goldberg28 reported 79% of patients achieved a distance UCVA of 20/20 or better and 100% of patients could read J2 unaided after all treatments, although they included a treatment range only up to +3.50 D. Reinstein et al.29 reported outcomes of hyperopic astigmatism and presbyopia using micro-monovision with the Carl Zeiss Meditec MEL80 Platform (Dublin, CA); binocularly, 95% of patients achieved 20/20 and 100% achieved 20/40, 91% could read J2 and 100% could read J5, 95% of patients could read 20/20 and J5, and the re-treatment rate was 22%. In our study, the re-treatment rate was 6.75%, probably because the micro-monovision induced was lower (−0.50 D) than in the study of Reinstein et al.,29 in which they induced micro-monovision between −1.00 and −1.50 D in the non-dominant eye.
There were significantly more negative spherical aberration and vertical coma postoperatively (P < .05), although the measurement was confined to the central mesopic 5-mm pupil.
After 55 years of age, “presbyopic lens exchange” is an alternative to treat presbyopia. Nevertheless, it is an invasive intraocular procedure that even in expert hands can lead to complications such as endophthalmitis, retinal detachment, and cystoid macular edema. In our subgroup, the refractive results were the same as the other patients but the re-treatment rate was higher. The choice of using one or the other should be based on the patient’s age, individual eye factors, and desires, as well as the surgeon’s clinical judgment.
A more extensive study should evaluate preoperative contrast sensitivity and further compare multifocal LASIK to multifocal intraocular lens results.
As with the many other presbyopia correction procedures, the improvement of near vision involves a compromise, which needs to be discussed and explained to the patient. This procedure of central presbyLASIK SUPRACOR providing micro-monovision was well tolerated and effective for treating patients with presbyopia with low and moderate hyperopia.
- Chang JS, Ng JC, Lau SY. Visual outcomes and patient satisfaction after presbyopic lens exchange with a diffractive multifocal intraocular lens. J Refract Surg. 2012;28:468–474. doi:10.3928/1081597X-20120612-01 [CrossRef]
- Tsaousis KT, Plainis S, Dimitrakos SA, Tsinopoulos IT. Binocularity enhances visual acuity of eyes implanted with multifocal intraocular lenses. J Refract Surg. 2013;29:246–250. doi:10.3928/1081597X-20130318-03 [CrossRef]
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- Yilmaz OF, Alagoz N, Pekel G, et al. Intracorneal inlay to correct presbyopia: long-term results. J Cataract Refract Surg. 2011;37:1275–1281. doi:10.1016/j.jcrs.2011.01.027 [CrossRef]
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|Parameter||Dominant Eye||Non-dominant Eye|
|All Patients||Patients ⩾ 55 Years||Patients < 55 Years||All Patients||Patients ⩾ 55 Years||Patients < 55 Years|
|HOA RMS 5 mm||0.30 ± 0.12||0.43 ± 0.13a||0.34 ± 0.08||0.43 ± 0.14a||0.28 ± 0.13||0.42 ± 0.12a||0.30 ± 0.10||0.48 ± 0.12a||0.35 ± 0.13||0.45 ± 0.08a||0.26 ± 0.06||0.51 ± 0.15a|
|Spherical aberration||0.21 ± 0.12||−0.06 ± 0.11a||0.25 ± 0.12||−0.05 ± 0.10a||0.19 ± 0.12||−0.07 ± 0.12a||0.21 ± 0.14||−0.14 ± 0.18a||0.21 ± 0.14||−0.10 ± 0.17a||0.23 ± 0.15||−0.18 ± 0.19a|
|Vertical coma||0.04 ± 0.19||−0.31 ± 0.23a||0.11 ± 0.23||−0.23 ± 0.27a||−0.02 ± 0.13||−0.38 ± 0.16a||0.05 ± 0.19||−0.31 ± 0.28a||0.10 ± 0.23||−0.18 ± 0.27a||0.008 ± 0.10||−0.43 ± 0.23a|
|Vertical trefoil||−0.08 ± 0.20||0.02 ± 0.23||−0.15 ± 0.19||−0.04 ± 0.24||−0.02 ± 0.19||0.08 ± 0.21||−0.08 ± 0.18||0.03 ± 0.20||−0.16 ± 0.19||−0.002 ± 0.13||−0.009 ± 0.13||0.072 ± 0.24|
|Horizontal coma||0.005 ± 0.15||−0.04 ± 0.17||0.002 ± 0.18||−0.027 ± 0.20||0.007 ± 0.12||−0.06 ± 0.14||−0.096 ± 0.16||0.07 ± 0.24||−0.10 ± 0.16||0.012 ± 0.15||−0.09 ± 0.16||0.14 ± 0.35|
|Horizontal trefoil||−0.02 ± 0.11||−0.02 ± 0.12||−0.01 ± 0.14||0.001 ± 0.13||−0.02 ± 0.08||−0.05 ± 0.10||−0.03 ± 0.15||0.03 ± 0.17||−0.06 ± 0.18||−0.008 ± 0.18||−0.004 ± 0.12||0.08 ± 0.15|