The aim of this study was to evaluate the safety and efficacy of a violet-light filtering intraocular lens (IOL) compared to a colorless IOL control. This was a prospective, bilateral, randomized, comparative, patient/evaluator-masked multi-center clinical trial at 12 sites in the USA. Patients underwent standard small-incision phacoemulsification cataract extraction. Visual acuity, contrast sensitivity, and color vision were tested 12months postoperatively. Patient satisfaction and vision-related quality of life were evaluated based on directed patient responses obtained from a binocular subjective questionnaire. A total of 250 subjects were bilaterally implanted with the violet-light filtering TECNIS monofocal ZV9003 (n = 126) and colorless TECNIS monofocal ZA9003 (n = 124). Mean uncorrected distance visual acuity (UDVA) was 0.123 LogMAR for ZV9003 and 0.116 LogMAR for the ZA9003 group. Mean corrected distance visual acuity (CDVA) was 0.00 LogMAR for both groups. No significant difference was found between the groups for 22/25 questionnaire categories, including color perception. A significant difference was found in favor of the ZV9003 group for day driving, night driving, and frustration with vision. Contrast sensitivity mean difference was < 0.05 log units across all lighting conditions and spatial frequencies. No difference was found between groups for visual acuity, contrast sensitivity, color testing, and adverse events as well as with the majority of optical/visual symptoms. A statistical difference was noted in driving and frustration with eyesight that may be related to benefits of using a violet-light filtering chromophore. Overall, the violet-light filtering ZV9003 showed excellent visual acuity and contrast sensitivity results with a low incidence of optical/visual symptoms.

PurposeThe purpose of this study is to evaluate and compare the correlation between changes in vision and HD Analyzer dual-pass metrics versus changes in vision and conventional subjective slit lamp gradings in pseudophakic patients with posterior capsular opacity undergoing neodymium:yttrium-aluminum-garnet (Nd:YAG) capsulotomy.Patients and MethodsHigh contrast (HC) and low contrast (LC) best spectacle-corrected distance visual acuity (BCVA) and HD Analyzer evaluation were prospectively performed on patients with mild-to-moderate posterior capsular opacification (PCO) and monofocal and accommodating intraocular lens implants. Differences between pre- and post-operative measurements were calculated, along with the correlation of HD Analyzer metrics and slit lamp grading to changes in visual acuity.ResultsFollowing Nd:YAG capsulotomy (n=29), there was statistically significant improvement in HC-BCVA and LC-BCVA, decrease in optical scatter, and corresponding improvement in Strehl ratio and HD Analyzer values at all contrast levels tested (p≤0.05). Pearson test showed a high correlation between the improvement in HC-BCVA (r coefficient = 0.78) and LC-BCVA (r coefficient = 0.71) to the improvement in Objective Scatter Index (OSI). There was a higher correlation of change in HC-BCVA to pre-op OSI (r2=0.61) than to the subjective PCO grading score (r2 = 0.19). There was also a higher correlation of change in LC-BCVA to pre-op OSI (r2 = 0.49) than to subjective grading (r2 = 0.16).ConclusionThe HD Analyzer provides objective measurements of forward light scatter (ie, light directed towards the retina) that can assist with both PCO grading and prediction of improvement of visual quality after YAG laser capsulotomy with higher accuracy than conventional slit lamp assessment based upon backscatter (ie, light traveling to the observer) in patients tested with monofocal and accommodating intraocular lens implants.

We report two cases that underwent corneal inlay implantation under a femtosecond flap. The first case had no complications during the postoperative period. Pentacam maps remained stable over time: corneal densitometry (CD) values had less than 2 units of change across visits up to 3 years. Axial/sagittal topography maps showed a stable K_max (∼47 D), i.e., less than 1 D change between visits. The second case developed haze at 8 months postoperatively. CD increased by more than 4 units from 3 to 8 M and K_max increased by 2.6 D. The patient was prescribed steroids and 1 month later the haze regressed, resulting in pre-haze CD and K_max values, similar to the ones at 3 months.

The purpose of this review is to summarize recent literature and provide clinical pearls for the use of intracorneal inlays for surgical treatment of presbyopia. A preoperative manifest refraction spherical equivalent (MRSE) in the appropriate range for a KAMRA or Raindrop inlay aids with optimization of postoperative visual results. An eye with MRSE of −0.75 is ideal for consideration of KAMRA inlay, whereas plano to +0.50 MRSE tends to have better visual results with Raindrop. Both KAMRA and Raindrop corneal inlays are effective surgical treatment options for presbyopia. Patient selection, preoperative counseling, surgical implantation that is centered, optimized corneal depth, and appropriate postoperative management are vital to patient and surgeon success with the technology.

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.

We incorporated anterior chamber components, axial length, and wavefront measurements to construct pilot customized eye models for extensive applications. 21 normal and diseased eyes were successfully constructed with RMS 0.01 wave accuracy.

To evaluate the safety and effectiveness of the aspheric diffractive Tecnis multifocal ZM900 (TCMF) intraocular lens (IOL; Abbott Medical Optics, Inc, Santa Ana, California, USA). One-year, nonrandomized, multicenter, evaluator-masked, bilateral, parallel-group comparative clinical evaluation. Subjects underwent bilateral implantation with the TCMF IOL or the CeeOn 911A monofocal (CEMN) IOL (Abbott Medical Optics, Inc) according to subject preference. One-year results were available for 244 eyes of 125 TCMF IOL subjects and for 245 eyes of 123 CEMN IOL subjects. Mean distance visual acuities (VAs) were statistically and clinically equivalent between the 2 groups. Mean binocular and monocular uncorrected and distance-corrected near VAs were significantly better for the TCMF IOL versus the CEMN IOL group (P < .0001). A greater proportion of TCMF IOL versus CEMN IOL subjects achieved binocular combined VAs of 20/25 distance and 20/32 near (84.2% [96/114] vs 6.2% [7/113]; P < .0001). The TCMF IOL group had excellent depth of focus, maintaining a mean of 20/40 or better for far, intermediate, and near distances. Mean contrast sensitivity scores were lower for the TCMF IOL versus the CEMN IOL group, but the differences were not considered clinically significant. Halos and night glare were more common in the TCMF IOL versus the CEMN IOL groups. Both reading acuity (20/20 vs 20/47; P < .0007) and speed (148 vs 117 words/minute; P < .0001) were significantly better for the TCMF IOL versus the CEMN IOL group, as were the proportions of the TCMF IOL group versus the CEMN IOL group that achieved spectacle independence (84.8% vs 5.2%; P < .0001) and that functioned comfortably at near without glasses (96.4% vs 30.4%; P < .0001). The TCMF IOL provided enhanced near VA, reading acuity per speed, depth of focus, and spectacle independence compared with the monofocal IOL.