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 《-》

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 ... -  《-》

Refractive corneal inlay for near vision improvement after cataract surgery.

We present the case of a patient who had refractive corneal inlay implantation for near vision improvement after bilateral cataract surgery. The patient had a history of bilateral cataract, and a 2-step procedure was suggested to improve her near and distance visual acuities. The first step was bilateral cataract extraction with a power target of plano intraocular lens implantation. Six months later, a refractive corneal inlay, Presbia Microlens, was implanted in the nondominant eye in the intracorneal pocket made with the femtosecond laser. No intraoperative or postoperative complications occurred. The bilateral uncorrected near visual acuity improved from less than Jaeger (J)6 to J1 and remained stable during the 2-year follow-up. The refractive corneal inlay is a safe, simple, and efficient method for improving near visual acuity in patients after cataract surgery. Dr. Pallikaris is the chair of the medical advisory board of Presbia Coöperatief U.A. No other author has a financial or proprietary interest in any material or method mentioned.

Stojanovic NR ，Panagopoulou SI ，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 ... -  《-》

Visual outcomes and safety of a refractive corneal inlay for presbyopia using femtosecond laser.

To evaluate the outcomes and safety of a refractive inlay (Flexivue Micro-Lens, Presbia Coöperatief U.A.) for the corneal compensation of presbyopia. This prospective, interventional clinical study comprised 47 emmetropic presbyopes with a mean age of 52±4 years (range: 45 to 60 years). The inlay was inserted, centered on the line of sight, inside a corneal pocket created in the patient's nondominant eye, using a femtosecond laser. Follow-up was 12 months. Visual acuity, corneal topography, wavefront aberrometry, contrast sensitivity, structural corneal alterations, and questionnaires were evaluated. Twelve months after surgery, uncorrected near visual acuity was 20/32 or better in 75% of operated eyes, whereas mean uncorrected distance visual acuity (UDVA) of operated eyes was statistically significantly decreased from 0.06±0.09 logMAR (20/20) (range: -0.08 to 0.26) preoperatively to 0.38±0.15 logMAR (20/50) (range: 0.12 to 0.8) (P<.001), and mean binocular UDVA was not significantly altered (P=.516). Seventeen patients lost one line of corrected distance visual acuity in the operated eye. No patient lost 2 lines in CDVA in the operated eye. Overall, higher order aberrations increased and contrast sensitivity decreased in the operated eye. No tissue alterations were found using corneal confocal microscopy. No intra- or postoperative complications occurred. Twelve months after implantation, the Flexivue Micro-Lens intracorneal refractive inlay seems to be an effective method for the corneal compensation of presbyopia in emmetropic presbyopes aged between 45 and 60 years old.

Limnopoulou AN ，Bouzoukis DI ，Kymionis GD ，Panagopoulou SI ，Plainis S ，Pallikaris AI ，Feingold V ，Pallikaris IG ... -  《-》