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 ... -  《-》

Combined Cataract and Refractive Corneal Inlay Implantation Surgery: Comparison of Three Techniques.

To compare clinical outcomes of three different techniques of combined cataract and Presbia Flexivue Microlens refractive corneal inlay (Presbia Coöperatief U.A., Amsterdam, Netherlands) implantation surgery for presbyopia compensation over a 12-month follow-up. In this comparative pilot study, 15 patients with bilateral cataract were allocated to one of three groups with a different combination of surgical steps (cataract surgery, intrastromal pocket creation, and inlay implantation). In the three-step group, the intracorneal pocket was created in the non-dominant eye, bilateral cataract surgery was performed 3 months later, and the intracorneal inlay was inserted 3 months after that. In the two-step at 3 days group, bilateral cataract surgery was performed 3 days after pocket creation and inlay implantation in the non-dominant eye. In the two-step at 3 months group, the pocket creation and the inlay implantation were performed in the non-dominant eye 3 months after bilateral cataract surgery. Visual, refractive, and contrast sensitivity outcomes were evaluated and compared between the three groups. Twelve months after the inlay implantation, mean monocular uncorrected distance visual acuity was 20/32 in the three-step group, 20/32 in the two-step at 3 days group, and 20/25 in the two-step at 3 months group. Achieved mean monocular uncorrected near visual acuity was similar in the three groups (20/25). The visual and refractive outcomes did not show significant differences between groups. Contrast sensitivity was similar between groups under mesopic and photopic conditions. No intraoperative or postoperative complications were observed. Clinical outcomes of three different techniques of combined cataract surgery and refractive corneal inlay implantation had no apparent differences between them. The corneal inlay provided excellent near vision acuity, with high patient satisfaction and a high spectacle independence rate after cataract surgery. [J Refract Surg. 2016;32(5):318-325.].

Stojanovic NR ，Feingold V ，Pallikaris IG 《-》

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 ... -  《-》

Outcomes of small aperture corneal inlay implantation in patients with pseudophakia.

To evaluate the improvement in near visual acuity after KAMRA corneal inlay (AcuFocus, Inc., Irvine, CA) implantation in patients with pseudophakia. A retrospective study analysis of patients with pseudophakia undergoing monocular corneal inlay implantation in the non-dominant eye was performed. The inlay was implanted monocularly in the non-dominant eye of patients. Manifest refractive spherical equivalent, uncorrected distance visual acuity, corrected distance visual acuity, uncorrected near visual acuity, and corrected near visual acuity were evaluated. The follow-up period was 3 months. Thirteen eyes from 13 patients were evaluated. Four patients underwent LASIK for improved distance acuity at the time of inlay implantation. Mean uncorrected near visual acuity improved five lines (from J10 to J4) postoperatively. Mean uncorrected distance visual acuity, corrected distance visual acuity, and corrected near visual acuity remained stable and were 20/20, 20/16, and J1, respectively, before and after KAMRA implantation. Three eyes lost two lines and 1 eye lost one line of uncorrected distance visual acuity. Two eyes lost two lines and 1 eye lost 1 line of corrected distance visual acuity. Mean manifest refractive spherical equivalent changed before and after KAMRA implantation from -0.01 ± 1.07 diopters (D) (range: 2.25 to -1.88 D) to -1.12 ± 0.87 D (range: 0.25 to -2.75 D), respectively. Implantation of a small aperture corneal inlay improved uncorrected near visual acuity while maintaining uncorrected and corrected distance visual acuity in monofocal patients with pseudophakia.

Huseynova T ，Kanamori T ，Waring GO 4th ，Tomita M ... -  《-》

Femtosecond laser-assisted small-aperture corneal inlay implantation for corneal compensation of presbyopia: two-year follow-up.

To report the 2-year postoperative safety and efficacy outcomes after monocular Kamra corneal inlay (ACI7000PDT) implantation in femtosecond laser-created corneal pockets of emmetropic presbyopic patients to improve near and intermediate vision. University Eye Clinic, Paracelsus Medical University, Salzburg, Austria. Prospective interventional case series. Patients had corneal inlay implantation in the nondominant eye. Emmetropic presbyopic patients between 45 and 60 years old with an uncorrected distance visual acuity (UDVA) of 20/20 or better in both eyes and without additional ocular pathology were eligible. Contrast sensitivity, visual field examinations, endothelial cell count (ECC), and central corneal thickness (CCT) measurements were assessed preoperatively and 12 and 24 months postoperatively. The UDVA, uncorrected intermediate visual acuity (UIVA), and near visual acuity (UNVA) were assessed preoperatively and 1 day, 1 week, and 1, 3, 6, 9, 12, 18, and 24 months postoperatively. The minimum postoperative follow-up was 24 months. After 24 months, the mean binocular UNVA improved from 20/50 to 20/25; 20 patients (83%) had a UNVA of 20/25 or better. The mean binocular UIVA was 20/20. The mean UDVA was 20/20 in the surgical eye and 20/16 binocularly after 24 months. Contrast sensitivity under photopic and mesopic conditions remained in the range of the normal population. No patient had detectable central visual field defect. No inlay was explanted. No inflammatory reactions were observed. The ECC and CCT remained stable. The corneal inlay implanted in femtosecond laser-created pockets was effective and safe for the corneal compensation of presbyopia in emmetropic patients after 24 months. Acufocus Inc., Irvine, California, USA, financially supports the Research Foundation for Promoting Ophthalmology, Salzburg, Austria, as the clinical research center of the University Eye Clinic (Paracelsus Medical University). Dr. Grabner received travel expenses from Acufocus, Inc. Dr. Riha currently also works as a clinical application specialist for Acufocus, Inc. No other author has a financial or proprietary interest in any material or method mentioned.

Seyeddain O ，Bachernegg A ，Riha W ，Rückl T ，Reitsamer H ，Grabner G ，Dexl AK ... -  《-》