Comparison Combined LASIK Procedure for Ametropic Presbyopes and Planned Dual Interface for Post-LASIK Presbyopes Using Small Aperture Corneal Inlay

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1 Comparison Combined LASIK Procedure for Ametropic Presbyopes and Planned Dual Interface for Post-LASIK Presbyopes Using Small Aperture Corneal Inlay Minoru Tomita, MD, PhD 1,2 1) Shinagawa LASIK, Tokyo, Japan 2) Department of Ophthalmology, Wenzhou Medical College, Wenzhou, China Hawaiian Eye, Comprehensive Ophthalmologist Program January 24 th, 2014

2 Disclosures Ownership Interest: AcuFocus

3 Shinagawa Shinagawa LASIK LASIK Characteristics of small aperture corneal inlay The central aperture increases the depth of field. The patient is able to achieve improved vision for near with minimal effect on distance vision. Several published papers reported the small aperture corneal inlay is effective for the treatment of presbyopia 1-4. Sources 1.Yilmaz et al, Intracorneal inlay to correct presbyopia: Long-term results Jul;37: Seyeddain et al, Smallaperture corneal inlay for the correction of presbyopia: 3-year follow-up. J Cataract Refract Surg Jan;38: Tomita et al, Simultaneous corneal inlay implantation and laser in situ keratomileusis for presbyopia in patients with hyperopia, myopia, or emmetropia: six-month results. J Cataract Refract Surg Mar;38: Tomita et al, Small-aperture corneal inlay implantation to treat presbyopia after laser in situ keratomileusis. J Cataract Refract Surg 2013;39:

4 Purpose To report over 10,000 cases of small aperture corneal inlay implantation for the treatment of presbyopia. p Two surgical methods for different patient groups: CLK- Combination with simultaneous LASIK under the LASIK flap for ametropic presbyopes PLK/PLK2- Implantation into the pocket interface for post-lasik presbyopes. The inlay is an investigational device in the United States and is limited by federal law to investigational use only. It is not available for sale in the United States. The inlay is available for use in Japan. This study is followed by the Ethical Board Committee in Japan. This study is followed by the Ethical Board Committee in Japan. All the patients read and signed informed consent forms.

5 Inclusion Criteria: CLK PLK / PLK2 SE (D) -9.0 to to +0.5 Cylinder (D) less than Pachymetry over 470μm (RBT over 280μm) over 450μm Keratometry (D) 39.0 to 47.0 N/A * years * Endothelial l Cell Density Count : over 2000/mm 2 For * No severe dry eye all surgeries * Topography : no irregular patterns * No ocular/cornea disease/immune system disorders (same as LASIK) * UNVA(IE) : less than J3 Others * CDVA(IE) : better than 20/25 * at least 1M post-lasik RBT=Residual Bed Thickness, IE=Inlay eye

6 Surgical Procedure: Non-dominant eye: (Implanted eye) Dominant eye: CLK 1. Creation of 200μm thick flap 2. Excimer laser ablation with target postop refraction of D. 3. Inlay implantation Normal LASIK surgery was performed with 100μm flap thickness with post-op target refraction of plano PLK / PLK2 1. Creation of corneal pocket, between 200 and 250μm depth, below the previous LASIK flap. * Enhancement performed, when needed, to achieve a post-op op refraction of plano. 2. Inlay impalnation into pocket interface. N/A - LDV Z6 (Ziemer) or ifs (IntraLase) femtosecond lasers and ( ) ( ) Allegretto(WaveLight) or Amaris (Schwind) excimer lasers were used.

7 Shinagawa Shinagawa LASIK LASIK Surgical Video

8 Shinagawa Shinagawa LASIK LASIK OCT Scan The image shows that the previous LASIK flap was made at about 100µm and the small aperture corneal inlay was implanted at 200µm from the anterior cornea.

9 Shinagawa Shinagawa LASIK LASIK Results

10 1 Year Results: Implanted Eye CLK n UDVA Preop /125 1Y 2207 UNVA 30cm J6 (75% myopic) MRSE (D) (Mean SD) CDVA CNVA 30cm /16 J1 20/20* J2* 20/16 J * (+8 lines) (+3 lines) ( 0) ( 0) PLK/ PLK2 Preop /16 1Y /20* ( -1 line) J6 (24% myopic) /16 J1 J2* (+3 lines) * 20/16 ( 0) J1 ( 0) * With significant difference between preoperative and 1-year result (p<0.05) CLK gained 8 lines of UDVA and 3 lines of UNVA. PLK/PLK2 lost 1 line of UDVA and gained 3 lines of UNVA. For both groups, mean UDVA of 20/20 and UNVA of J2 were achieved.

11 Mean UDVA Implanted Eye CLK n=3,317, 3,317, 3,267, 3,183, 2,989, 2,604, 2,207 PLK n=7,148, 7,142, 7,031, 6,711, 5,981, 5,080, 3,169 After 3 months, both procedures have a mean UDVA of 20/20 which h remained stable throughout the 1 year postoperative period.

12 Mean UNVA Implanted Eye CLK n=3,317,, 3,317,, 3,267,, 3,183,, 2,989,, 2,604,, 2,207 PLK n=7,148, 7,142, 7,031, 6,711, 5,981, 5,080, 3,169 After 1 month, both procedures have a mean UNVA of J2 which h remained stable throughout the 1 year postoperative period.

13 Mean Corrected Visual Acuity Implanted Eye CLK n=3,317, 317 3,267, 3,183, 2,989, 2,604, 2, PLK n=7,148, 7,031, 6,711, 5,981, 5,080, 3,169 For both procedures, mean CDVA remained the same from preoperative 20/16 up to 1 year postoperative.

14 Mean Corrected Visual Acuity Implanted Eye CLK n=3 3,317, 317 3,267, 3,183, 2,989, 2,604, 2, PLK n=7,148, 7,031, 6,711, 5,981, 5,080, 3,169 For both procedures, mean CNVA remained the same from preoperative J1 p, p p up to 1 year postoperative.

15 Shinagawa Shinagawa LASIK LASIK Patient Satisfaction and Necessity of reading glasses Both groups had more than 90% of satisfaction after 6 months. Necessity of reading glasses resulted in less than 10% after 3 months: 6% for CLK and 8% for PLK/PLK2 procedure.

16 Shinagawa LASIK Shinagawa LASIK Scores of Subjective Questionnaire Daily Activity Patients were asked to rate their performance in activities at various distances, from the scale of 1 to 7 (1:very difficult to 7: very easy). For both groups after 3 months, improvements are seen in tasks for near, intermediate, and distance vision and remained the same up to 1 year. CLK PLK/ PLK2 72% of the patients were myopic at preoperative 77% of the patients were myopic at preoperative

17 Shinagawa LASIK Dryness Score There were significant differences found in patient subjective dryness symptom scores at 3 and 6 months, with more subjective symptoms of dry eye in CLK than PLK(PLK2). Score Scale: 0 (no symptoms) to 7(very severe) * * *with significant difference (p<0.05)

18 Shinagawa LASIK OSI (Optical Scatter Index) Although there was no significant difference in OSI preoperatively, there were significant differences found at 1 and 6 months postoperative, with higher OSI values in CLK than in PLK/PLK2. *with significant difference (p<0.05)

19 Conclusions 1 year results of over 10,000 cases of small aperture corneal inlay CLK group 3,317 patients gained 8 lines in UDVA (20/20) and gained 3 lines In UNVA (J2). Post-LASIK group 7,148 patients gained 3 lines in UNVA (J2) and lost 1 line in UDVA (20/20) CLK patients experienced more dry eye but Post-LASIK group experienced fewer dry eye symptoms at 3M/6M and also better scores in OSI at 1M/6M than CLK patients. Some patients experienced difficult driving due to unwanted visual symptoms Small aperture corneal inlay implantation is a good treatment option for emmetropic and ametropic presbyopes p and also for post-lasik presbyopes.