LASIK for Presbyopia Correction in Emmetropic Patients ... · LASIK for Presbyopia Correction/Reinstein et al The purpose of this study was to document the safety and efﬁ cacy of

531Journal of Refractive Surgery • Vol. 28, No. 8, 2012

O R I G I N A L A R T I C L E S

LASIK for Presbyopia Correction in Emmetropic Patients Using Aspheric Ablation Profi les and a Micro-monovision Protocol With the Carl Zeiss Meditec MEL 80 and VisuMaxDan Z. Reinstein, MD, MA(Cantab), FRCSC, FRCOphth; Glenn I. Carp, MBBCh, FC Ophth(SA); Timothy J. Archer, MA(Oxon), DipCompSci(Cantab); Marine Gobbe, PhD, MSTOptom

ABSTRACT

PURPOSE: To evaluate the monocular and binocular visual outcomes of LASIK with an aspheric micro-mono-vision protocol in emmetropic patients with presbyopia.

METHODS: A retrospective, noncomparative case series included 296 eyes from 148 consecutive emmetropic patients with presbyopia who were treated with LASIK-induced micro-monovision. The CRS-Master software was used to generate ablation profi les for the MEL 80 excimer laser (Carl Zeiss Meditec) and fl aps were cre-ated using the VisuMax femtosecond laser (Carl Zeiss Meditec). The target refraction was plano for distance eyes (dominant eye) and between �1.00 and �1.88 diopters (D) for near eyes. Patients were followed for 1 year. Emmetropia was defi ned for inclusion as spherical equivalent refraction ��0.88 D, sphere ��1.00 D, and cylinder �1.25 D. Median patient age was 55 years (range: 44 to 65 years). Median follow-up was 12.9 months.

RESULTS: Mean deviation from intended correction was �0.02�0.35 D, with 91% within �0.50 D and 100% within �1.00 D. Of distance eyes, 95% achieved uncorrected distance visual acuity (UDVA) of 20/20 or better and 100% achieved 20/32 or better. Binocularly, 98% of patients achieved UDVA of 20/20 or better and 100% achieved 20/32 or better; 96% achieved uncor-rected near visual acuity of J2 and 99% could read J3 or better. No eyes lost 2 or more lines of corrected distance visual acuity. An average increase of 0.05 logMAR was noted in distance-corrected near visual acuity. A small increase occurred in mesopic contrast sensitivity (CSV-1000, VectorVision Inc) at 3 cycles per degree (cpd) (P=.016) and no change at 6, 12, or 18 cpd.

CONCLUSIONS: This aspheric micro-monovision proto-col was a well-tolerated and effective procedure for treat-ing emmetropic patients with presbyopia. [J Refract Surg. 2012;28(8):531-539.] doi:10.3928/1081597X-20120723-01

he treatment of presbyopia in emmetropic patients is currently one of the biggest challenges in refrac-tive surgery and a number of different approaches

have been used, including LASIK monovision,1 corneal mul-tifocal ablation,2 corneal inlays,3-6 conductive keratoplasty,1 intrastromal femtosecond concentric rings,7,8 and refractive clear lens exchange with multifocal or accommodative intra-ocular lenses (IOL).9

We previously described the Laser Blended Vision (Carl Zeiss Meditec, Jena, Germany) technique in myopic10 and hyperopic populations11 that combines control of spherical aberration to increase depth of fi eld with micro-monovision (anisometropia of 1.50 diopters [D] in the nondominant eye irrespective of age). In emmetropic patients, as the refractive error correction is small, inducing signifi cant spherical aber-ration would require a multifocal ablation, but this has been shown to reduce quality of vision, such as decreased contrast sensitivity,12 increased glare and halos,12,13 and loss of cor-rected distance visual acuity (CDVA).14,15 Emmetropic pres-byopic patients often have high expectations because they already have good distance vision and are not used to wear-ing glasses. Therefore, refractive accuracy and safety (both in terms of quantity and quality of vision) are paramount in these patients. For this reason, the Laser Blended Vision mod-ule uses a low degree of asphericity in emmetropic patients and relies more on the near vision afforded by micro-mono-vision together with the depth of fi eld increase afforded by a change in spherical aberration.

From London Vision Clinic, London, United Kingdom (Reinstein, Carp, Archer, Gobbe); the Department of Ophthalmology, Columbia University Medical Center, New York, New York (Reinstein); and Centre Hospitalier National d’Ophtalmologie, Paris, France (Reinstein).

Dr Reinstein has a proprietary interest in the Artemis technology (ArcScan Inc, Morrison, Colorado) and is an author of patents related to VHF digital ultrasound administered by the Cornell Center for Technology Enterprise and Commercialization, Ithaca, New York. Dr Reinstein is a consultant for Carl Zeiss Meditec (Jena, Germany). The remaining authors have no proprietary or financial interest in the materials presented herein.

Correspondence: Dan Z. Reinstein, MD, MA(Cantab), FRCSC, FRCOphth, London Vision Clinic, 138 Harley St, London W1G 7LA, United Kingdom. Tel: 44 207 224 1005; Fax: 44 207 224 1055; E-mail: [email protected]

Received: February 2, 2012; Accepted: May 31, 2012

T

532 Copyright © SLACK Incorporated

LASIK for Presbyopia Correction/Reinstein et al

The purpose of this study was to document the safety and effi cacy of LASIK with the MEL 80 excimer laser and VisuMax femtosecond laser (Carl Zeiss Meditec) to treat emmetropic patients with presbyopia using an aspheric micro-monovision protocol.

PATIENTS AND METHODSThis study was a retrospective, noncomparative

case series including 160 consecutive emmetropic presbyopic patients undergoing LASIK between November 15, 2007 and June 9, 2010, at the London Vision Clinic, London, United Kingdom. Inclusion cri-teria were medically suitable for LASIK; no previous ocular, eyelid or orbital surgery; no visually signifi cant cataract; emmetropic refraction in both eyes; distance-corrected near visual acuity (DCNVA) of J3 or worse in both eyes; CDVA 20/20 or better in both eyes; and mini-mum 1-year follow-up. An emmetropic refraction was de-fi ned as spherical equivalent refraction ��0.88 D, mani-fest sphere ��1.00 D, and manifest cylinder �1.25 D. Informed consent and permission to use their data for analysis and publication were obtained from all pa-tients.

Median follow-up after the primary treatment was 12.9 months. All patients who had not attended 1-year follow-up were contacted by telephone. Of these, 12 (7.5%) patients lived far from London or abroad and were unwilling to travel. These patients were classi-fi ed as lost to follow-up and were excluded from the analysis. Of the 148 patients included for analysis, the last time point after the primary procedure was 6 months for 1.7% of eyes (n=5) and 1 year for the re-maining 98.3% of eyes (n=293). Eyes for which the last time point was earlier than 1-year follow-up under-went retreatment at that time.

The following represents the standard treatment protocol for emmetropic presbyopic patients in our practice since August 1, 2003.

PREOPERATIVE ASSESSMENTA full ophthalmologic examination was performed

by an in-house optometrist as described previously.10,11

MICRO-MONOVISION ASSESSMENTThe protocol used to determine the amount of in-

duced myopic target, or “add,” to use in the nondomi-nant eye has been described in detail previously.10,11 The age of the patient was not a consideration when choosing the add; rather an add of 1.50 D was used whenever possible and was reduced only if necessary until the patient reported no cross-blur (as defi ned previously10,11). The add was increased to �1.50 D only if the patient could not comfortably read J2. No contact

lens monovision trials were performed. Patients were counseled to expect an adaptation period of at least 3 to 6 months and subjective cross-blur was recorded postoperatively using the following grading categories: none, slight, mild, moderate, and severe.

SURGICAL PROCEDUREAll patients underwent bilateral simultaneous

LASIK using the MEL 80 excimer laser and VisuMax femtosecond laser by one of two surgeons (D.Z.R. [63%], G.I.C [37%]). The CRS-Master software platform (Carl Zeiss Meditec) was used to generate the ablation profi les (version 2.1.6 until November 1, 2009, and ver-sion 2.3.0 after this date). Proprietary aspheric ablation profi les were used for all eyes, which incorporated a small amount of spherical aberration determined ac-cording to the patient’s age, preoperative spherical aberration, and the amount of refractive correction; the profi les were intended to control the induction of spherical aberration to a level that would provide an increased depth of fi eld, but without affecting contrast sensitivity and quality of vision. Optical treatment zone diameters were 6.00 mm (in 17%), 6.50 mm (in 49%), and 7.00 mm (in 34%). Intended fl ap thickness was 90 μm in 23%, 95 μm in 0.7%, 100 μm in 44%, 110 μm in 16%, and 120 μm in 17% of eyes. Flap diameter was 8.4 mm in 65%, 8.9 mm in 9%, and 9.2 mm in 26% of eyes.

POSTOPERATIVE EVALUATIONPatients were instructed to wear plastic shields

while sleeping for 7 nights. Topical tobramycin 0.3%/dexamethasone 0.1% and ofl oxacin 0.3% were applied four times daily for the fi rst week, which is our standard protocol for broad spectrum prophylaxis. Pa-tients were reviewed at 1 day and 1, 3, 6, and 12 months using our standard protocol as described previously.10,11 Slit-lamp examination was performed at all postopera-tive follow-up visits and superfi cial punctuate keratitis was recorded using a six-grade classifi cation system: none, trace, I-II (not visually signifi cant), and III-V (vi-sually signifi cant). All postoperative examinations were conducted by one of seven in-house optometrists. Mani-fest refraction was performed based on a standardized protocol,16 and all optometrists had undergone refrac-tion training with this protocol.

A retreatment was offered to all patients who could gain two lines of uncorrected distance visual acuity (UDVA) and patients with cylinder �0.75 D. Retreat-ments were performed once stability was demonstrated over a 2-month interval (stability was defi ned as no change in sphere within �0.25 D and change in cylin-der within �0.50 D).



STATISTICAL ANALYSISOutcome measures were calculated according to the

standardized graphs as originally defi ned by Waring.17-19 The outcomes were analyzed for the primary treatment and for fi nal results after all treatments. For eyes that re-ceived retreatment, the refraction and vision at the time of retreatment were used for the primary outcome analysis. The mesopic contrast sensitivity was converted into log values before calculating statistics. The mean normalized mesopic contrast sensitivity ratio was calculated.20 Stu-dent paired t tests were used to assess the change in me-sopic contrast sensitivity, and to compare UDVA, CDVA, DCNVA, and uncorrected near visual acuity (UNVA) (logMAR). Average pre- and postoperative spherical aberration was calculated for a 6-mm analysis zone using Optical Society of America (OSA) notation.21 Microsoft Excel 2007 (Microsoft Corp, Redmond, Washington) was used for data entry and statistical analysis.

RESULTSTwo hundred ninety-six eyes from 148 consecutive

patients (41% male, 59% female) were included in the fi nal analysis. Median patient age was 55 years (range: 44 to 65 years). Table 1 shows descriptive statistics of the preoperative, intended, and attempted spherical equivalent refraction and the mean deviation from the

intended spherical equivalent refraction after primary treatment and after all treatments grouped into dis-tance and near eyes.

Table 2 presents preoperative patient characteristics and target spherical equivalent refraction of the near eye. The right eye was dominant in 64% of patients.

Figure 1 presents effi cacy in terms of UDVA and UNVA before and after the primary treatment and after all treatments grouped into binocular and distance and near eyes monocularly. Figure 2 presents the standard graphs for reporting refractive surgery, with the UDVA effi cacy histogram replaced by a histogram showing the change in lines of DCNVA (as the UDVA histogram is included in Figure 1). The attempted versus achieved scatterplot only includes data after all treatments. The stability plot includes data after the primary treatment only. The remaining four graphs include data after the primary treatment and after all treatments. Figure 3 presents the combined binocular distance and near visual acuity before and after all treatments. Figure 4 shows the defocus equivalent before and after all treat-ments for distance eyes only.

Table A (available as supplemental material in the PDF version of this article) shows the mean UDVA, CDVA, and DCNVA before and after the primary treat-ment and after all treatments grouped into binocular

TABLE 1

Mean Spherical Equivalent Refraction of Distance and Near Eyes Before and After

Primary Treatment and All TreatmentsSpherical Equivalent Refraction

(Mean�SD [Range]) (D)

Eyes

Parameter Distance Near

Preoperative�0.25�0.43

(�0.88 to �1.00)�0.24�0.48

(�0.88 to �1.00)

Intended after primary treatment

�0.01�0.04 (�0.13 to 0.00)

�1.52�0.09 (�1.88 to �1.00)

Attempted�0.26�0.43

(�0.88 to �1.00)�1.76�0.49

(�0.63 to �2.75)

After primary treatment�0.04�0.34

(�0.75 to �1.13)�1.46�0.42

(�2.50 to �0.38)

Difference between eyes after primary treatment

1.50�0.48 (0.38 to 3.13)

Intended after all treatments

�0.01�0.04 (�0.13 to 0.00)

�1.53�0.11 (�1.88 to �1.00)

1 year after all treatments

�0.01�0.26 (�0.75 to �0.75)

�1.49�0.40 (�2.50 to �0.50)

Difference between eyes 1 year after all treatments

1.48�0.44 (0.38 to 2.50)

TABLE 2

Preoperative Patient Characteristics and Target Spherical Equivalent

Refraction in the Near EyeParameter Mean�SD (Range)

Cylinder (D) 0.44�0.31 (0.00 to 1.25)

Corneal thickness (µm) 546.1�29.8 (484 to 673)

Pupil diameter* (mm)

Scotopic 5.40�0.75 (3.36 to 7.50)

Mesopic 4.57�0.73 (3.01 to 6.79)

Keratometry (D) 43.20�1.30 (39.40 to 47.50)

Target SE (D) No. of Patients (%)

�1.00 1 (0.7)

�1.25 5 (3.4)

�1.38 1 (0.7)

�1.50 117 (79.1)

�1.63 18 (12.2)

�1.75 7 (4.7)

�1.88 1 (0.7)

SD = standard deviation, SE = spherical equivalent refraction*P3000 dynamic pupillometer (Procyon Instruments Ltd, London, United Kingdom).



Figure 1. Cumulative histograms of uncorrected distance visual acuity (left column) and uncorrected near visual acuity (right column) for before (dark grey bars) and after the primary treatment (blue bars) and after all treatments (red bars), grouped into binocular (first row), distance eyes (second row), and near eyes (third row). The preoperative corrected distance visual acuity (light grey bars) is also shown for distance and near eyes.



Figure 2. The standard graphs for reporting refractive surgery, with the uncorrected distance visual acuity (UDVA) efficacy histogram replaced by a histogram showing the change in lines of distance-corrected near vision acuity (as the UDVA histogram is already included in Figure 1). The attempted versus achieved scatterplot only includes data after all treatments and the linear regression equation and coefficient of determination (r2) are displayed. The stability plot only includes data after the primary treatment. The other four graphs include data after the primary treatment and after all treatments.



and distance and near eyes. Binocular UDVA was one line better than monocular UDVA of the distance eye in 23 (16%) patients, these were the same in 116 (78%) patients, and binocular UDVA was one line worse than monocular UDVA of the distance eye in 9 (6%) patients. The improvement of binocular UDVA com-pared to monocular UDVA of the distance eyes was statistically signifi cant (P=.01).

Table 3 shows the incidence of cross-blur 3 months after the primary treatment and 1 year after all treatments.

Of the eyes that lost one line of CDVA after all treat-ments, 18% were 20/12.5 preoperatively, 76% were 20/16 preoperatively, and 5% were 20/20 preopera-tively; 99.3% (296/298) achieved CDVA 20/20 or bet-ter postoperatively.

Table 4 shows the mean normalized mesopic con-trast sensitivity ratio before and after the primary treat-ment at 3, 6, 12, and 18 cycles per degree (cpd). There was a statistically signifi cant improvement in mesopic contrast sensitivity at 3 cpd, and no statistically sig-nifi cant change at 6, 12, and 18 cpd.

The following complications were experienced. Intra-operative epithelial defects occurred in 12 (4.1%) eyes, of which 5 eyes gained 1 line of CDVA and 7 eyes had no change in CDVA after the primary treatment. Table B (available as supplemental data in the PDF version

of this article) presents the percentage of eyes with su-perfi cial punctate keratitis before and 1 year after the primary treatment. One (0.3%) eye had visually signifi -cant superfi cial punctate keratitis at 1 year. Two (0.7%) cases of suction loss occurred during the creation of the fl ap interface. Both cases were managed using the stan-dard repair mode to reapply the contact glass, resulting in normal fl aps with no bed irregularities as confi rmed intraoperatively.

In accordance with our retreatment policy and defi ni-tion of stability, the retreatment rate was 11.8% (35/296 eyes), of which 14 (40%) were for distance eyes and 21 (60%) for near eyes. Of the 28 patients who underwent a retreatment, 7 (25%) received bilateral retreatments. The mean requested increase in myopic spherical equivalent refraction of the near eye was �0.27 D (range: �0.13 to �0.38 D). No patients required the myopic refraction of the near eye to be reduced from target. No patients re-quested the distance and near eyes be switched.

Table 5 shows the mean spherical aberration be-fore and after the primary treatment, and the change in spherical aberration grouped by distance and near eyes.

DISCUSSIONThis aspheric micro-monovision protocol in a popu-

lation of emmetropic presbyopic patients achieved re-sults similar to those previously reported for myopic10 and hyperopic populations.11 Uncorrected binocular visual acuity of 20/20 at distance and J3 at near was achieved in 99% of patients with no loss of CDVA or contrast sensitivity.

The aspheric micro-monovision protocol was well tolerated, with only fi ve (3.4%) patients who did not tolerate anisometropia of �1.50 D and just one (0.7%)

Figure 3. Combined distance and near binocular visual acuity before (blue data points) and after all treatments (red data points). Two ellipses are plotted to represent the mean and one standard deviation of the combined distance and near binocular visual acuity before (blue line) and after all treatments (red line). Distance vision is displayed on the x-axis, near vision is displayed on the y-axis and the number of patients with each combina-tion of distance and near vision is represented by the relative size and darkness of the data points. Guidelines are plotted (orange dashed lines) to highlight 20/20 and 20/25 distance vision, and J2 and J5 near vision.

Figure 4. Histogram of defocus equivalent before and after all treatments for the distance eyes only.



patient who did not tolerate �1.25 D on preoperative screening. Also, no patient requested the target spheri-cal equivalent refraction of the near eye be reduced, nor did any patient request both eyes be corrected for distance vision after the primary treatment. The tol-erance was similar to that observed in a hyperopic population11 but better than that observed in a myo-pic population, where 12% of patients did not tolerate anisometropia of �1.00 D.10 However, the myopic population was younger (median 49 years) than both the hyperopic (median 56 years) and emmetropic (me-dian 55 years) populations. In the myopic population, all but one of the patients, who could only tolerate �0.75 D in the near eye, were younger than 49 years of age, whereas the majority of patients older than 54 years could tolerate �1.50 D in the near eye. This sug-gests that patients with mild presbyopia are less toler-ant to a larger degree of anisometropia than patients with advanced presbyopia, which agrees with previ-ous reports.22 The tolerance to micro-monovision was also monitored by recording subjective cross-blur. Although mild/moderate cross-blur was observed in 35 (24%) patients at 3 months, only 10 (7%) patients reported mild/moderate cross-blur at 1 year, demon-strating that the neural adaptation process takes �3 months in most patients, but can take up to �1 year in a few patients.

Another interesting fi nding in this study was that the average DCNVA increased by 0.05 log units (approximately half a line) in both the distance and near eyes. This appears to demonstrate a small in-crease in depth of fi eld despite only a small degree of asphericity used in the ablation profi le. Alternatively, this could be a systematic effort–related bias.

Femtosecond LASIK monovision has been reported previously with the EC-5000 excimer laser (NIDEK Co Ltd, Gamagori, Japan) and IntraLase FS30 (Abbott Medical Optics, Santa Ana, California), although only the nondominant eye was treated using a target refrac-

tion of �1.50 D.1 Mean UNVA was J3 compared with J1.5 in the present study. The study by Ayoubi et al1 also reported results of monovision using conductive keratoplasty; spherical equivalent refraction regressed by 1.04 D (65%) over 18 months and induced average cylinder of 1.04 D, resulting in a mean UNVA of J5.5.

Multifocal ablation profi les have been described, but currently no published reports exist regarding their use in emmetropic presbyopes. However, published studies using multifocal ablation profi les in hyper-opic and myopic patients show a reduction in quality of vision, including decreased contrast sensitivity,12 increased glare and halos,12,13 and loss of CDVA.14,15

Pinhole intracorneal inlays are designed to increase the depth of fi eld based on the principle of pinhole optics to restore near and intermediate acuity without signifi cantly impacting distance vision, with the most common being the KAMRA (AcuFocus Inc, Irvine, Cali-fornia). The fi rst generation KAMRA inlay (ACI-7000, AcuFocus Inc) was 10-μm thick with 1600 micrope-rforations.4,23,24 The design and materials were then improved (ACI-7000PDT, AcuFocus Inc) to reduce the thickness to 5 μm and increase the number of micro-perforations to 8400.5,6 The results of the published studies using the KAMRA corneal inlay4-6,23,24 are in-

TABLE 3

Incidence of Cross-blur PostoperativelyNo. of Eyes (%)

3 Months After Primary Treatment (n=148)

1 Year After All Treatments (n=148)

None 86 (58) 114 (77)

Trace 27 (18) 24 (16)

Mild 25 (17) 5 (3)

Moderate 10 (7) 5 (3)

Severe 0 (0) 0 (0)

TABLE 4

Mean Normalized Mesopic Contrast Sensitivity Ratio Before and After the

Primary TreatmentCPD Preoperative Postoperative P Value

3 0.95 0.96 .016*

6 0.95 0.95 .669

12 0.97 0.96 .270

18 0.94 0.92 .530

CPD = cycles per degree*Increase in mesopic contrast sensitivity.

TABLE 5

Change in Spherical Aberration*

Eyes PreopAfter Primary

Treatment Change in SA

Distance 0.14�0.13 (�0.19 to 0.49)

0.07�0.15 (�0.32 to 0.60)

�0.08�0.10 (�0.36 to 0.24)

Near 0.15�0.12 (�0.18 to 0.44)

�0.13�0.15 (�0.51 to 0.37)

�0.29�0.11 (�0.53 to 0.00)

SA = spherical aberration*Optical Society of America notation.All measurements are in microns.



cluded in Table C (available as supplemental mate-rial in the PDF version of this article). The binocular UNVA was comparable to the present study, although the results with the new ACI-7000PDT were slightly worse (Waring6 reported mean UNVA between J2 and J3, logMAR 0.14). The potential advantage of corneal inlays is that UDVA of at least 20/32 is retained in the eye treated for near vision, whereas only 16% of near eyes in the present study could achieve 20/32. However, binocular UDVA is similar with both tech-niques and the inlay population reported by Yilmaz et al4,23 showed that binocular UDVA decreased from 100% 20/20 to 73% 20/20 between 1 and 4 years. On the other hand, micro-monovision relies on the natural process of binocular neural summation and achieves excellent binocular vision despite comparatively blurred distance vision in the near eye. This may be partly explained by the fact that even the small refrac-tive error has been corrected in the distance eye in the present study (as demonstrated by the defocus equiva-lent analysis in Figure 4), but needs to be confi rmed by further study. The safety of corneal inlays is not yet comparable to LASIK, with a 4% to 6% loss of two lines of CDVA reported in two studies5,24 and a signifi -cant decrease in contrast sensitivity in the two studies that reported contrast sensitivity data.6,24

Refractive intracorneal inlays are also being used to treat presbyopic patients. The fi rst refractive corneal in-lays (Permavision; Anamed Inc, Anaheim, California) were associated with poor refractive predictability and loss of CDVA.25 More recent models have improved the design, such as the Flexivue Microlens (Presbia, Los Angeles, California),26 the PresbyLens (ReVision Optics Inc, Lake Forest, California), and the Invue Lens (Biovision AG, Bruggs, Switzerland). Using the Invue Lens in a population of emmetropic patients with presbyopia, binocular UDVA was 20/20 or better in 20% of patients and 20/25 or better in all patients, and binocular UNVA was J2 or better in 76% and J3 or better in 98% of patients.27 No eyes lost more than one line of CDVA; however, there was a decrease in contrast sensitivity.

Refractive lens exchange has also been used as a treatment for emmetropic presbyopes by combining clear lens extraction with multifocal or accommodating IOLs to address myopic and hyperopic refractive errors, including presbyopia, and simultaneously eliminating the need for cataract surgery in the future.9 The out-comes reported in the study of 46 eyes by Alfonso et al9 were good with mean UDVA of 20/21, mean UNVA of J1.5, and no loss of 2 lines of CDVA. However, refractive lens exchange removes all residual accommodation and intraocular surgery introduces the risk of potentially

catastrophic complications, such as the 0.07% risk of endophthalmitis, 1% to 6% risk of macular edema, 0.04% risk of suprachoroidal hemorrhage, 0.25% to 0.41% risk of retinal detachment, and 7% to 31% risk of posterior capsular opacifi cation.28 This seems a large risk to introduce for 50- to 60-year-old patients with good distance vision when less than half are likely to undergo cataract surgery during their lifetime.29

Recently, a new technique has been suggested in which a series of concentric cylindrical ring cuts are created intrastromally using a femtosecond laser to induce a central steepening to improve near vision (INTRACOR; Technolas Perfect Vision GmbH, Munich, Germany).7,8 The study by Ruiz et al7 reported mean UNVA of J1.5 at 6 months; however, 2 (2.4%) eyes lost 2 lines CDVA. A prospective study by Holzer et al8 re-ported mean logMAR UNVA of 0.26 (between J2 and J3) and a loss of one line of CDVA in 42% and two lines of CDVA in 8.3% of eyes. At this stage, UNVA and safety do not compare with the other treatment modalities, the long-term stability of the central in-duced steepening is unknown, contrast sensitivity and quality of vision have been reported to be reduced,30 refractive error cannot be corrected simultaneously, and a retreatment is not currently possible.

This aspheric micro-monovision protocol achieved functional binocular uncorrected distance and near vi-sion without compromising safety in terms of CDVA or contrast sensitivity, while enabling simultaneous cor-rection of even small refractive errors; a combination that has not been demonstrated with any other presby-opic treatment option.

AUTHOR CONTRIBUTIONSStudy concept and design (D.Z.R., G.I.C., T.J.A., M.G.); data col-

lection (D.Z.R., G.I.C., T.J.A.); analysis and interpretation of data

(D.Z.R., T.J.A., M.G.); drafting of the manuscript (T.J.A.); critical re-

vision of the manuscript (D.Z.R., G.I.C., M.G.); statistical expertise

(T.J.A.)

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18. Reinstein DZ, Waring GO III. Graphic reporting of outcomes of refractive surgery. J Refract Surg. 2009;25(11):975-978.

19. Waring GO III, Reinstein DZ, Dupps WJ Jr, et al. Standardized graphs and terms for refractive surgery results. J Refract Surg. 2011;27(1):7-9.

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24. Seyeddain O, Hohensinn M, Riha W, et al. Small-aperture cor-neal inlay for the correction of presbyopia: 3-year follow-up. J Cataract Refract Surg. 2012;38(1):35-45.

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TABLE A

Mean logMAR (Snellen) Visual Acuities for Binocular, Distance, and Near Eyes

Eyes Preoperative After Primary Treatment After All TreatmentsP Value

(Preoperative to Final)

Binocular

UDVA 0.01�0.12 (20/20.6) �0.05�0.10 (20/17.7) �0.07�0.08 (20/17.0) �.001

UNVA 0.54�0.20 (20/69.9) 0.06�0.09 (20/23.2) 0.05�0.07 (20/22.2) �.001

Distance eyes

UDVA 0.07�0.14 (20/23.4) �0.04�0.10 (20/18.1) �0.06�0.08 (20/17.3) �.001

CDVA �0.08�0.06 (20/16.7) �0.10�0.07 (20/15.8) �0.10�0.07 (20/15.7) �.001

UNVA 0.59�0.20 (20/78.6) 0.56�0.16 (20/73.4) 0.55�0.15 (20/70.2) .012

DCNVA 0.57�0.15 (20/74.7) 0.53�0.13 (20/67.3) 0.52�0.13 (20/66.0) �.001

Near eyes

UDVA 0.09�0.15 (20/24.4) 0.42�0.19 (20/52.7) 0.43�0.18 (20/53.6) �.001

CDVA �0.07�0.06 (20/17.0) �0.07�0.07 (20/17.0) �0.07�0.07 (20/16.9) .541

UNVA 0.60�0.20 (20/78.9) 0.07�0.09 (20/23.3) 0.05�0.07 (20/22.4) �.001

DCNVA 0.57�0.15 (20/73.6) 0.51�0.12 (20/64.0) 0.51�0.12 (20/64.6) �.001

UDVA = uncorrected distance visual acuity, UNVA = uncorrected near visual acuity, CDVA = corrected distance visual acuity, DCNVA = distance-corrected near visual acuity

TABLE B

Superficial Punctate Keratitis Before and 1 Year After Primary Treatment

No. of Eyes (%)

SPK Grade Preoperative 1 Year

None 274 (92.6) 256 (86.5)

Trace 19 (6.4) 33 (11.1)

I 3 (1.0) 6 (2.0)

II — —

III — 1 (0.3)

SPK = superficial punctate keratitits

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Documents

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