EyeWorld Asia-Pacific September 2019 Issue

52 EWAP SEPTEMBER 2019 by Jay Pepose, MD, PhD, Robert Ang, MD, and Jocelyn Remo, MD Pearls, pitfalls of small aperture inlay for unhappy pseudophakic patients Contact information Pepose: jpepose@peposevision.com Ang: rtang@asianeyeinstitute.com Remo: jmremo@asianeyeinstitute.com This article originally appeared in the May 2019 issue of EyeWorld . It has been UNKIJVN[ OQFKƂGF CPF CRRGCTU JGTG YKVJ permission from the ASCRS Ophthalmic Services Corp. T he KAMRA inlay (CorneaGen) is a thin, carbon-impregnated polyvinylidene corneal inlay with a 1.6-mm central aperture and 3.8-mm outer diameter placed in a deep femtosecond-laser assisted corneal stromal pocket to provide extended depth of focus by blocking unfocused peripheral rays of light via small aperture optics. While the inlay is not approved for use in pseudophakes, surgeons can and have used new medical devices off-label when there is good medical rationale and an exercise of sound medical judgment in the best interest of the patient. We are grateful to Drs. Fox, Augustine, and Wiley for sharing their experience with the off-label use of the KAMRA inlay in pseudophakes. Dr. Fox and colleagues used the KAMRA inlay in two clinical different settings: (1) in patients bilaterally implanted with monofocal IOLs and (2) in patients implanted with multifocal IOLs. In patients with monofocal IOLs, by targeting –0.75 D in the nondominant iÞi] ̅ˆÃ ňvÌà ̅i y>Ì `ivœVÕà curve produced by the KAMRA inlay to the right, expanding through focus with minimal impact on distant vision. This ˆÃ ÃÕ««œÀÌi` LÞ Ì…i w˜`ˆ˜}à ˆ˜ Case 3 of Dr. Fox et al.’s article in a patient with pseudophakic mini-monovision, where the UCDVA in the nondominant eye improved from 20/40 to 20/20- 2 and the near improved from borderline J3 to J1+ following KAMRA implantation. These w˜`ˆ˜}à >Ài ÛiÀÞ Ãˆ“ˆ>À ̜ ܅>Ì has been reported when the inlay has been used in phakic patients 1 and also when the small aperture is integrated into an IOL 2 (IC-8 IOL, AcuFocus), and the patient is targeted for –0.75 D in the small aperture eye. Another advantage of this approach is enhanced stereopsis with the inlay in place compared to in patients with a comparable amount of monovision without the inlay. 3 In further support of this concept, a prospective, randomized, clinical trial was conducted of the KAMRA inlay in the nondominant eye of patients undergoing «…>Vœi“ՏÈwV>̈œ˜ ܈̅ bilateral monofocal IOLs. In this trial, the inlay was implanted in the nondominant iÞi ˆ˜ > «Ài“>`i Óää ù“ femtosecond laser-assisted corneal pocket immediately >vÌiÀ «…>Vœi“ՏÈwV>̈œ˜ >˜` implantation of a three-piece Tecnis monofocal IOL (Johnson & Johnson Vision), with the same monofocal IOL also placed in the dominant eye, vs. the same IOL bilaterally implanted in the control group. The manifest refraction in the nondominant inlay implanted eye was –0.39 ± 0.66 D. With 12 weeks of follow-up, investigators found a ÃÌ>̈Ã̈V>Þ È}˜ˆwV>˜Ì ˆ˜VÀi>Ãi in uncorrected intermediate vision in the inlay cohort vs. the control and a two-line enhancement in near vision, although the latter did not reach ÃÌ>̈Ã̈V> È}˜ˆwV>˜Vi° /…ˆÃ improvement in unaided near and intermediate vision was Vœ˜wÀ“i` LÞ > y>ÌÌiÀ `ivœVÕà curve in the inlay group, with no ÃÌ>̈Ã̈V>Þ È}˜ˆwV>˜Ì `iVÀi>Ãi in binocular contrast sensitivity œÀ ۈÃÕ> wi` ÌiÃ̈˜}° 4 Drs. Ang and Remo have had similar experience in adding the KAMRA inlay to the nondominant eye of four patients with another monofocal IOL, the Crystalens (Bausch + Lomb), which is labeled as having the equivalent of about 1 D of accommodation. The mean preoperative refraction was +0.125 sphere and –0.50 cylinder. The mean uncorrected distance visual acuity was 20/25 REFRACTIVE p9G ƂPF VJG TCVKQPCNG HQT WUG KP monofocal IOL patients sound and UVTCKIJVHQTYCTF *QYGXGT WUG of the inlay as a primary treatment HQT FKUUCVKUƂGF RCVKGPVU YKVJ multifocal IOLs may have more RQVGPVKCN FQYPUKFGU q