Implantation of a Corneal Inlay in Pseudophakic Eyes: A Prospective Comparative Clinical Trial.
To compare the clinical outcomes of binocular cataract surgery with and without pinhole corneal inlay implantation.
In the inlay-cataract group, a small aperture corneal inlay was implanted in addition to cataract surgery in the non-dominant eye and routine cataract surgery was performed in the dominant eye. In the control group, conventional cataract surgery was performed in both eyes in separate consecutive surgeries 2 weeks apart. The target refraction was emmetropia. Visual acuity, refraction, contrast sensitivity, and visual field were analyzed 1, 4, and 12 weeks after surgery.
Sixteen patients with advanced cataracts underwent cataract surgery on both eyes in separate surgeries. There was no statistically significant difference regarding mean age, Lens Opacities Classification System grading, and refractive outcome. The difference in uncorrected distance visual acuity between the control group and inlay-cataract group was not statistically significant after 12 weeks (P = .59). Mean uncorrected intermediate visual acuity was significantly better in the inlay-cataract group (P = .03). Near visual acuity was better in the inlay-cataract group, but it was not statistically significant (P = .07). There was no statistically significant difference between groups under binocular photopic and mesopic conditions with and without glare. The results of the visual field examination showed no statistically significant difference between both eyes.
The findings demonstrate that implantation of monofocal IOLs in combination with a small aperture corneal inlay in the non-dominant eye helps to increase intermediate and near visual acuity. The implantation of small aperture corneal inlays seems to be an interesting alternative for pseudophakic patients who desire spectacle independence. [J Refract Surg. 2018;34(11):746-750.].
Elling M
，Schojai M
，Schultz T
，Hauschild S
，Dick HB
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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
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