Inlays and the cornea.

Presbyopia is a growing problem in view of an aging global population and increasingly patients desire spectacle-free solutions to address this condition. Surgically implanted corneal inlays have been the topic of renewed research efforts in the past several years as a treatment option for presbyopia, with several approaches being used to modify the refractive properties of the cornea and enhance near vision. In this review we discuss historical approaches to corneal inlay surgery, critically appraise the current generation of presbyopia-correcting corneal inlays and their associated complications and consider the future prospects for emerging corneal inlay technologies that aim address the shortcomings of currently available inlays.

Fenner BJ ，Moriyama AS ，Mehta JS 《-》

Corneal inlays for presbyopia correction.

Lindstrom RL ，Macrae SM ，Pepose JS ，Hoopes PC Sr ... -  《-》

Surgical compensation of presbyopia with corneal inlays.

Konstantopoulos A ，Mehta JS 《-》

Treatment of Presbyopia in Emmetropes Using a Shape-Changing Corneal Inlay: One-Year Clinical Outcomes.

To report 1-year safety and efficacy clinical outcomes of a shape-changing corneal inlay for the treatment of presbyopia. Prospective, nonrandomized, multicenter United States Food and Drug Administration Investigational Device Exemption clinical trial (clinicaltrials.gov identifier, NCT01373580). Nondominant eyes (N = 373) of emmetropic presbyopic subjects were implanted at 11 sites with the Raindrop Near Vision Inlay (ReVision Optics, Lake Forest, CA); 340 eyes underwent the 1-year follow-up visit. The corneal inlay was implanted under a corneal flap at the center of the light-constricted pupil created with a femtosecond laser. For subjects completing the 1-year follow-up, monocular and binocular uncorrected and corrected visual acuity, refractive stability, contrast sensitivity (CS; photopic and mesopic), symptom and satisfaction questionnaire results, and adverse events. At 1 year in the treated eye, on average, uncorrected near visual acuity (UNVA) improved by 5.1 lines, uncorrected intermediate visual acuity (UIVA) improved by 2.5 lines, and uncorrected distance visual acuity (UDVA) decreased by 1.2 lines. From 3 months through 1 year, 93% of subjects achieved UNVA of 20/25 or better, 97% achieve UIVA of 20/32 or better, and 95% achieved UDVA of 20/40 or better. Binocularly, the mean UDVA exceeded 20/20 from 3 months through 1 year. Contrast sensitivity loss occurred only at the highest spatial frequencies, with no loss binocularly. Absent or mild scores were reported in 96% of subjects for visual symptoms (glare, halos, double vision, and fluctuations in vision), in 99% for ocular symptoms (pain, light sensitivity, and discomfort), and in 95% for dryness. Adverse events were treatable and resolved. Eighteen inlays were replaced, usually soon after implantation because of decentration, but UNVA was little affected in this group thereafter. In the 11 cases requiring inlay explantations, 100% achieved a corrected distance visual acuity of 20/25 or better by 3 months after explant. The Raindrop Near Vision Inlay provides significant improvement in near and intermediate visual performance, with no significant change in binocular distance vision or CS. Subject satisfaction is improved significantly with minimal ocular or visual symptoms.

Whitman J ，Dougherty PJ ，Parkhurst GD ，Olkowski J ，Slade SG ，Hovanesian J ，Chu R ，Dishler J ，Tran DB ，Lehmann R ，Carter H ，Steinert RF ，Koch DD ... -  《-》

Long-term Results of Combined LASIK and Monocular Small-Aperture Corneal Inlay Implantation.

To evaluate the long-term effectiveness and safety of combined LASIK and small-aperture intracorneal inlay implantation (KAMRA; AcuFocus, Irvine, CA) for the surgical compensation of presbyopia and refractive errors. Retrospective chart review of all ametropic, presbyopic patients who underwent combined LASIK and KAMRA inlay implantation at a single clinic. Demographic data and preoperative uncorrected and corrected monocular and binocular near and distance visual acuity (UNVA, UDVA, and CDVA) with manifest refractive spherical equivalent (MRSE) were collected and analyzed. All perioperative adverse events were recorded. In total, 132 patients were available (median age: 56 years; interquartile range (IQR) ± 5; range: 44 to 68 years). Median preoperative MRSE was +1.37± 1.20 diopters (D). The majority (113; 85%) were hypermetropic. Preoperative median UNVA improved from N24 (J13) ±6 to N6 (J5) ±1 by day 1 postoperatively, remaining stable throughout follow-up. At last follow-up, 97% of patients achieved UNVA of N5 (J3) or better. Median UDVA (implanted eye) improved from 20/40 (0.50 ± 0.41 on the decimal chart) preoperatively to 20/25 (0.80 ± 0.13) at month 12. Binocular UDVA was 20/20 in 88%, with CDVA unchanged for 84% at 12 months. No patient lost more than one line of CDVA. MRSE was also stable, albeit +0.25 D off-target refraction (-0.75 D). Two inlays were explanted due to suboptimal adaptation/corneal haze. The results of this follow-up study show that combined insertion of a small-aperture corneal inlay with LASIK in presbyopic patients improves near vision with a slight compromise in distance vision in the implanted eye. Overall, it appears to be a safe, effective procedure for the treatment of presbyopia. [J Refract Surg. 2016;32(6):379-384.].

Igras E ，O'Caoimh R ，O'Brien P ，Power W ... -  《-》