In the name of God Correction SUPRACOR multifocal corneal LASIK

Seyed Javad Hashemian MD Eye Research Center Rassoul Akram Hospital Iran University of Medical Sciences Iranian Eye Clinic No financial interest [email protected] www.drhashemian.com www.ireyeclinic.com ISOP Paris 2019 PresbyLASIK: There are currently three different approaches for PresbyLASIK.

CHAPTER 1 Terminology, Classifcation, and History of Refractive Surgery 13

Central PresbyLASIKMonovision , the central area Monovision improves near vision by giving one eye a slightly myopic correction, usually −1 D to −2 D. Te is shaped hyperpositivelyother eye is corrected fully for for distance.near vision remain- , ing in the dominant eye is called uncrossed monovision, and myopia remaining in the nondominant eye is called whereas the midperipheralcrossed monovision. Monovision treatments canfor be applied far to myopes, hyperopes, and emmetropes. For patients with myopia, the “near” eye is not treated for the full amount of myopic ; rather, it is left with a residual vision. myopic correction. In hyperopes, myopia must be created by “overcorrecting” the near eye. Keratorefractive options to achieve monovision have expanded in the past decade and Peripheral PresbyLASIKinclude PRK, LASIK, and conductive, the keratoplasty.central One area challenge to creating monovision with laser and conductive Fig. 1.13 Differences between ablation patterns. In peripheral pres- byLASIK, the center of the cornea is treated for distance vision and procedures is irreversibility. is shaped for far vision and the mid-peripheralthe periphery for near. In central presbyLASIK, the center of the cornea Following monovision treatment, patients must adapt to is treated for near vision and the periphery for distance vision. (Modifed its efect. Monovision patients have been found to perform from Vargas-Fragoso V, Alió JL. Corneal compensation of presbyopia: relatively worse with low levels of illumination, near- PresbyLASIK: an updated review. Eye Vis. 2017;4:11.) corneal area forthreshold near levels vision. of stimuli, and tasks requiring good depth perception.112,113 However, among patients who underwent PRK and LASIK monovision correction, between 88% and Side efects include postoperative glare, halos, ghost images, laser blended96% vision were satisf,ed iswith atheir combination visual outcome.114,115 of andmicro monocular- .monovision118–124 Treatment may be and limited by size and the degree of refractive error.110 Conductive Keratoplasty Pseudo-accommodative may take on two pos- increase depthWhile of conductive field, keratoplasty was approved in the United sible patterns: peripheral presbyLASIK creates a peripheral States for the treatment of presbyopia in emmetropes, the concentric near zone, while central presbyLASIK creates advantages that it ofers being a nonincisional, nonablative a central near zone (Fig. 1.13).125,126 A recent study of approach are limited by a high rate of refractive regression. presbyLASIK in myopes and hyperopes found that pres- In a retrospective consecutive single-surgeon study, Ayoubi byLASIK induced signifcant changes in spherical aberra- et al.116 compared FS-LASIK and conductive keratoplasty tion. In myopes, this yields the advantage of an increased for monovision treatment of the nondominant eye in pres- depth of focus relative to LASIK; in hyperopes, the spheri- byopic emmetropic patients. FS-LASIK monovision pro- cal aberration is more consistent, independent of refractive vided stable correction with less induced and change.127,128 Alió et al. demonstrated predictability, stability, HOA; the retreatment rate was 3% after FS-LASIK com- safety, and good visual outcomes with central presbyLASIK pared to 50% after CK (P <.0001). Stahl et al.117 evaluated in presbyopic patients with hyperopia.129,130 PresbyLASIK long-term follow-up for unilateral CK performed in the has also been combined with micro–monovision to allow nondominant eyes of near-plano presbyopic patients. Te for better intermediate vision stereoacuity than monovision postoperative refraction for these eyes eventually stabilized, alone.131 with no statistically signifcant change in mean manifest spherical equivalent or keratometry between 1 and 3 years. Corneal Inlays Corneal inlays are lenticules that are inserted into an FS- Multifocal Corneal Ablation and PresbyLASIK created corneal stromal pocket for the treatment of presby- Multifocal corneal ablation is still an experimental process opia. Tere are currently 3 types of corneal inlays available: in which the excimer laser is used to produce diferent the KAMRA (AcuFocus) inlay uses a pinhole efect; Presby- optical zones within the cornea that can serve distance or (ReVision Optics) is based on corneal shape changes; near vision (see Fig. 1.12). PresbyLASIK, a multifocal and Flexivue Microlens (Presbia) has a central plano zone corneal ablation procedure based on traditional LASIK, surrounded by peripheral ring segments of diferent refrac- creates a multifocal surface able to correct any visual defect tive indices. Tese inlays difer from monovision by preserv- for distance while reducing the near spectacle dependency. ing distance vision in the implanted eye. Te KAMRA inlay Tis multifocal cornea produces simultaneous images on was the frst FDA-approved implant in this class; long-term the , and the patient processes the appropriate image studies demonstrate good uncorrected near and intermedi- when performing distance or near tasks. For example, when ate vision, without an unacceptable decrease in distance looking at a distance target, the image produced by the vision. However, the KAMRA inlay restricts entering light optical zone(s) for distance will be in focus while light with the small aperture; in a small percentage of patients, passing through the near optical zone(s) will create blur. this causes glare, halos, and reduced contrast and night Comparing the three treatment modalities of PresbyLASIK:

Central PresbyLASIK shows a tendency to provide good near vision but reduced far vision, which translates to a compromised safety. Peripheral PresbyLASIK, seems to provide good far vision and safety, while providing a relatively poor near vision. Laser blended vision seems to have no major drawbacks, providing good far and near vision combined with a good safety. SUPRACOR SUPRACOR* presbyopic algorithm is suitable for the treatment of hyperopic (CE approved) myopic and post-LASIK eyes, providing near addition whilst minimizing undesired aberrations SUPRACOR utilizes ZYOPTIX Aspheric for Hyperopia, myopia Corneal K- and Q-Values to optimize the ablation Full X/Y- and rotational Eyetracking Supracor Supracor creates a varifocal cornea wherein there is a 12 µm elevation in the central 3 mm of the cornea to give a near addition of approximately two diopters (D). Outside of the near addition is an aberration-optimized transition zone that gives good intermediate and good distance vision. The algorithm is available in the Technolas 217P and Teneo 317 excimer lasers (Bausch and Lomb Techno- las, Munich, Germany). Since Supracor is a LASIK-based algorithm, its main advantage is it can correct refractive error and presbyopia in a single procedure. Supracor can be used in one eye or in both eyes depending on each patient’s needs and expectations. Supracor Basic Principle

Near Addition Intermediate Intermediate Zone & Distance Zone & Distance Zone Pre-op Cornea

Near and Post-op Cornea Central near addition far in focus Purpose: To assess the visual and refractive outcomes and complications of unilateral SURACOR multifocal corneal Femto-LASIK in non-dominant eye for the correction of hyperopia and presbyopia. Methods: This study enrolled 54 eyes of 27 patients who had bilateral femto-LASIK for the correction of hyperopia plus SURACOR multifocal corneal Lasik in non-dominant eye. Monocular and binocular uncorrected (UDVA) and corrected distance visual acuity (CDVA), monocular and binocular uncorrected (UNVA) and distance-corrected near visual acuity (DCNVA) at 40 cm, Central corneal power and High order aberrations changes and complications were evaluated over 6 months. Patient Demography

SUORACOR Dominant Eye Eye Patient (Eye/n) 54/27 (Mean±S 51.00±3.65 Age D) 45 - 60 Range Sex (%) Female Female 17 (63.0%) Male Male 10 (37) (Mean±S +1.54±0.69 +1.41±0.66 Pre-Operative MSE D) (0.00 - +3.75) (0.00 – 2.75) Range Ocular Dominance testing

Ocular dominance was assessed using the “hole test” . 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 look- ing through the hole. The eye with which the object appeared most centered through the hole was deemed to be the dominant eye. Inclusion Criteria

For hyperopic presbyopic patients Up to +3.0D MRSE, Up to 2.0D astigmatism Mean K-readings at 41.0D to 45.0D FSLASIK Flaps of 110µm, diameter = 9mm Angle Kappa < 8 Patients ≥ 47 years Near addition of +1.75 D minimum Maximal 0.75D difference between cycloplegic and manifest refraction SE Pupil between 3-6mm Central corneal thickness of 500 µm Both eyes with cc vision ≥ 0.8 Exclusion criteria:

Presence of ocular surface disease, Clinically significant corneal opacity Abnormal corneal topography, Any signs of anomalies at distance or near. Limitations for Lasik Surgery Results: Mean postoperative spherical equivalent refraction was - 0.030.52 diopters (D) for dominant eyes and -0.800.52 D for non-dominant eyes. Mean binocular UDVA was ³ 20/25. Mean binocular UNVA was ³Jaeger 2. At 6 months, 100% of patients achieved 20/25 and could read Jaeger 2 binocularly. Mean non-dominant eye UDVA was ³ 20/50 at 6 months. The mean central keratometry steepening was 2.51 D. There were significantly more negative spherical aberration and vertical coma in the central 6 mm postoperatively (P < .05). Ninety-eight percent of these patients did not need any glasses for distance and near vision. Results: Cumulative UCDVA in Dominant Eye

100%≥ 20/25 Results: Cumulative UCDVA in SupraCor

6.0 months postop; 80%≥20/50 Results: Cumulative CDVA in Dominant Eye

100%≥ 20/25 Results: Cumulative BCDVA in SupraCor 100%≥ 20/40 Results: Cumulative UCNVA in SupraCor

100%≥ J2 Results: Cumulative CDNVA in SupraCor

80%≥ J3

Results: Results: High order aberrations changes

SupraCor Pre-Op Post-Op P value Zernike RMS- High Order 6mm 0.46±0.08 0.72±0.29 0.004

Zernike RMS-HO w/o Z400 6mm 0.37±0.08 0.61±0.25 0.002

Zernike RMS- Total 1.64±0.63 1.10±0.36 0.000

Vertical coma- Z311 0.045±0.17 0.089±0.40 0.591 Horizontal coma- Z310 -0.002±0.23 -0.238±0.26 0.013

4th order spherical aberration- Z400 -0.24±0.11 0.38±0.20 0.000

Horizontal trefoil- Z330 0.039±0.09 0.105±0.17 0.036 Results: High order aberrations changes

Dominant Eye Pre-Op Post-Op P value Zernike RMS- High Order 6mm 0.47±0.13 0.47±0.11 0.884 Zernike RMS-HO w/o Z400 6mm 0.39±0.11 0.44±0.13 0.296 Zernike RMS- Total 1.86±0.52 1.00±0.31 0.000 Vertical coma- Z311 0.003±0.22 0.037±0.26 0.573 Horizontal coma- Z310 -0.023±0.14 -0.052±0.21 0.236 4th order spherical aberration- Z400 -0.25±0.11 0.07±0.13 0.000 Horizontal trefoil- Z330 -0.036±0.11 -0.044±0.18 0.829 Results: Cylinder Results: Mean SE

(Mean±SD) -0.86±0.58 +0.05±0.37 2 Month Post-Op SE Range (-2.00 - +0.50) (-0.50 - +1.00) Discussion: SUPRACOR is a corneal approach to treat hyperopic presbyopia. We induced micro-monovision with the Technolas excimer workstation 317P. Ryan and O’Keefe 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%. Co- sar and Sener 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, 100% of patients had a binocular UDVA of 20/25 or better for distance at 6 months postoperatively Discussion:

For near vision, 60.2% of patients had a UNVA of Jaeger 1 or better for near vision at 6 months and 100% of patients had a UNVA of Jaeger 2 or better. 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. 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. Long-term Outcomes of PresbyLASIK: Two effects may decrease patient satisfaction and spectacle independence in long-term follow up.

First, the natural tendency of the epithelium to shape a smooth, physiologic corneal surface,

Second, the simple fact that presbyopia may increase. Conclusions:

Supracor procedure in non-dominant eye may improve functional near, intermediate, and distance vision without significant photic phenomena in presbyopic patients with low and moderate hyperopia. ! ! Thank You for Kind Attention ! ! ! ! !

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