Development of a Patient-Reported Outcome Measure to Assess Symptoms Associated with Cataract Surgery and Intraocular Lens Implants.

PURPOSE: To develop a standardized patient-reported outcome measure of visual perceptions and symptoms for implanted premium and monofocal intraocular lenses (IOLs). DESIGN: Observational study before and after IOL implants to assess the measure and symptom experience. PARTICIPANTS: Adults scheduled for binocular implantation of the same IOL type completed the survey at baseline prior to surgery (n = 716) and postoperatively (n = 554). Most respondents were female (64%), White (81%), 61 or older (89%), and had some college or more education (62%). METHODS: Administration was by web survey with mail follow-up and phone reminders. MAIN OUTCOME MEASURES: Frequency, severity, and level of symptom bother in the last 7 days for 14 symptoms: (1) glare, (2) hazy vision, (3) blurry vision, (4) starbursts, (5) halos, (6) snowballs, (7) floaters, (8) double images, (9) rings and spider webs, (10) distortion, (11) light flashes with eyes closed, (12) light flashes with eyes open, (13) shimmering images, and (14) dark shadows. RESULTS: The median correlation among having 14 symptoms at baseline was only 0.19. Mean uncorrected binocular visual acuity improved from a preoperative value of 0.47 logarithm of the minimum angle of resolution (logMAR; Snellen 20/59) to a postoperative value of 0.12 (20/26) and best-corrected binocular visual acuity improved from 0.23 logMAR (20/34) preoperative to 0.05 logMAR (20/22) postoperative. The most bothersome symptoms were reduced after surgery: preoperative/postoperative glare (84%/36%), blurry vision (68%/22%), starbursts (66%/28%), hazy vision (63%/18%), snowballs (55%/17%), and halos (52%/22%). All symptoms decreased significantly (P < 0.0001) from before to after surgery except for dark crescent-shaped shadows (4%/4%). The percentage of symptoms rated as quite a bit or extremely bothersome declined from before to after surgery except for dark crescent-shaped shadows (29%/32%): blurry vision (54%/15%), snowballs (52%/14%), glare (49%/15%), and halos (46%/14%). Having monofocal IOL implants was associated with significantly more reduction in halos, starbursts, glare, and rings and spider webs, but less improvement in self-reported general vision. CONCLUSIONS: This study provides support for the 37-item Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) instrument for use to assess symptoms and general perceptions of vision in clinical studies and clinical care. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Symptoms and Satisfaction Levels Associated with Intraocular Lens Implants in the Monofocal and Premium IOL Patient-Reported Outcome Measure Study.

PURPOSE: To develop a questionnaire with standardized questions and images about visual symptoms and satisfaction administered before and after cataract surgery with monofocal and various (premium) intraocular lenses (IOLs). DESIGN: A prospective, observational study of cataract surgery patients completing a self-administered questionnaire preoperatively and postoperatively at 4 to 6 months. PARTICIPANTS: Five hundred fifty-four patients with plans to undergo implantation of the same IOL in both eyes on separate occasions in 20 ophthalmology practices. METHODS: An 86-item questionnaire with standardized images assessed the following 14 symptoms: glare, blurry vision, starbursts, hazy vision, snowballs, halos, floaters, double images, rings and spider webs, light flashes with eyes closed, distortion, light flashes with eyes open, shimmering images, and dark crescent-shaped shadows. MAIN OUTCOME MEASURES: Symptom severity and level of symptom bother, satisfaction with vision, quality of vision, and ability to see without corrective lenses or eyeglasses. RESULTS: Except for dark crescent-shaped shadows, the report of visual symptoms significantly decreased postoperatively. Best uncorrected binocular visual acuity improved from 0.47 (20/59 Snellen visual acuity values) ± 0.35 logarithm of the minimum angle of resolution (logMAR) preoperatively to 0.12 (20/26 Snellen visual acuity values) ± 0.12 logMAR postoperatively. Patients' ratings of intermediate vision as good to excellent improved significantly from 12% preoperatively to 71% postoperatively, and patients' ratings of distance vision improved from 8% preoperatively to 85% postoperatively. After surgery, 84% reported that they were somewhat, very, or completely satisfied with their vision. Most patients (88%) reported that they could see pretty well, very well, or perfectly well without corrective lenses after surgery. CONCLUSIONS: The Assessment of IntraOcular Lens Implant Symptoms questionnaire can be used across a wide variety of IOLs to evaluate visual symptoms and satisfaction with a growing segment of the market, premium IOLs, that target intermediate and near vision, in addition to distance vision. Compared to patients receiving monofocal IOLs, patients receiving premium IOLs appear to be more challenging to satisfy because of their requirements for distance, intermediate, and near vision, and their desire to be free of eyeglasses postoperatively. This instrument provides a structured, uniform tool for regulators, researchers, and ophthalmologists in everyday practice to gain insights into patients' experiences. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Femtosecond Lasers in Cornea & Refractive Surgery.

Since the introduction of femtosecond laser (FS) systems for corneal flap creation in laser-assisted in-situ keratomileusis there have been numerous applications for FS laser in corneal surgery. This manuscript details the utility of FS lasers in corneal surgical procedures including refractive laser surgeries, intracorneal ring segment tunnels, presbyopic treatments, and FS-assisted keratoplasty. We also review the role of FS lasers in diagnostic procedures such as two photon excitation fluorescence and second harmonic generation.

Technical note: Comparing dental topography software using platyrrhine molars.

OBJECTIVES: There remain many idiosyncrasies among the values calculated for varying dental topography metrics arising from differences in software preferences among research groups. The aim of this work is to compare and provide potential conversion formulae for dental topography metrics calculated using differing software platforms. METHODS: Three software packages: ArcGIS, Surfer Manipulator, and molaR were used to calculate orientation patch count rotated (OPCR), Dirichlet normal energy (DNE), occlusal relief (OR), slope (m), and angularity (a) on platyrrhine second upper molars. Values derived from the various software packages were compared for distributional consistency and correlation. Where appropriate, formulae for conversion between like measures calculated on different software platforms were developed. RESULTS: When compared with the same measurement across software, OPCR, OR, and slope were all highly correlated. However, only OR demonstrated distributional consistency (i.e., nearly consistent mean, median, max, and min). Slope and OPCR were both higher when calculated by molaR as compared to Surfer Manipulator and ArcGIS calculations, conversion formulae are provided for these measures. DNE is only weakly correlated with angularity; but is correlated with orientation patch count across taxa. DISCUSSION: We explore why there is variation in the dental topography values calculated among the various software packages. The conversion formulae provided in this work will make possible direct comparisons among studies conducted across multiple research groups.

Influence of a Therapeutic Soft Contact Lens on Epithelial Healing, Visual Recovery, Haze, and Pain After Photorefractive Keratectomy.

OBJECTIVES: To examine the influence of a therapeutic soft contact lens (TSCL) after alcohol-assisted photorefractive keratectomy (PRK) on visual recovery, epithelial closure, pain perception, and haze formation. METHODS: Prospective, randomized, single-center, contralateral eye, patient-masked study. Same surgeon treated 15 patients with bilateral PRK using a Vidaurri Fluid Retention Ring (Katena) with 8.7 mm inner diameter to apply ethanol 18% for 30 sec. Each patient received a TSCL (Balafilcon A, PureVision, Bausch & Lomb) in a randomized fashion in one eye only. RESULTS: Without knowing which eye had a contact lens, four patients preferred the eye with TSCL so much that these patients wanted a TSCL inserted in the second eye as well. Uncorrected distance visual acuity improved postoperatively from day 1 to 3 months from 0.61 to 1.18 with TSCL and from 0.21 to 1.04 without TSCL. Uncorrected distance visual acuity was statistically significantly better on days 1 and 2 with TSCL. Epithelial defect was on average smaller with TSCL. Epithelium was closed at day 4 in all eyes except one without TSCL. Pain perception was significantly lower with TSCL on days 1 and 2. Haze levels after 3 months were significantly lower with TSCL (with 0.09/without 0.45, respectively). One eye without TSCL had haze grade 2 (Fantes). CONCLUSIONS: A TSCL had statistically significantly and clinically meaningful beneficial effects in the first days in visual recovery and pain perception and after 3 months in haze formation. Epithelial healing was slightly quicker with the use of TSCLs (not statistically, but clinically significantly).

Contrasting cellular damage after Blue-IRIS and Femto-LASIK in cat cornea.

Blue-intra-tissue refractive index shaping (Blue-IRIS) is a new approach to laser refractive correction of optical aberrations in the eye, which alters the refractive index of the cornea rather than changing its shape. Before it can be implemented in humans, it is critical to establish whether and to what extent, Blue-IRIS damages the cornea. Here, we contrasted the impact of -1.5 D cylinder refractive corrections inscribed using either Blue-IRIS or femtosecond laser in-situ keratomileusis (femto-LASIK) on corneal cell viability. Blue-IRIS was used to write a -1.5 D cylinder gradient index (GRIN) lens over a 2.5 mm by 2.5 mm area into the mid-stromal region of the cornea in six freshly-enucleated feline eyes. The same correction (-1.5 D cylinder) was inscribed into another four cat eyes using femto-LASIK. Six hours later, all corneas were processed for histology and stained for terminal deoxynucleotidyl transferase-mediated dUTP-digoxigenin nick end labeling (TUNEL) and p-γ-H2AX to label damaged cells. In Blue-IRIS-treated corneas, no tissue was removed and TUNEL-stained cells were confined to the laser focal zone in the stroma. In femto-LASIK, photoablation removed 14 µm of anterior stroma, but in addition, TUNEL-positive cells clustered across the femto-flap, the epithelium at the flap edges and the stroma below the ablation zone. Keratocytes positive for p-γ-H2AX were seen adjacent to all Blue-IRIS focal zones, but were completely absent from femto-LASIK-treated corneas. Unlike femto-LASIK, Blue-IRIS attains refractive correction in the cornea without tissue removal and only causes minimal, localized keratocyte death within the laser focal zones. In addition, Blue-IRIS induced DNA modifications associated with phosphorylation of γ-H2AX in keratocytes adjacent to the laser focal zones. We posit that this p-γ-H2AX response is related to alterations in chromatin structure caused by localized changes in osmolarity, a possible mechanism for the induced refractive index changes.

Correlating optical bench performance with clinical defocus curves in varifocal and trifocal intraocular lenses.

PURPOSE: To investigate the correlations existing between a trifocal intraocular lens (IOL) and a varifocal IOL using the "ex vivo" optical bench through-focus image quality analysis and the clinical visual performance in real patients by study of the defocus curves. METHODS: This prospective, consecutive, nonrandomized, comparative study included a total of 64 eyes of 42 patients. Three groups of eyes were differentiated according to the IOL implanted: 22 eyes implanted with the varifocal Lentis Mplus LS-313 IOL (Oculentis GmbH, Berlin, Germany); 22 eyes implanted with the trifocal FineVision IOL (Physiol, Liege, Belgium), and 20 eyes implanted with the monofocal Acrysof SA60AT IOL (Alcon Laboratories, Inc., Fort Worth, TX). Visual outcomes and defocus curve were evaluated postoperatively. Optical bench through-focus performance was quantified by computing an image quality metric and the cross-correlation coefficient between an unaberrated reference image and captured retinal images from a model eye with a 3.0-mm artificial pupil. RESULTS: Statistically significant differences among defocus curves of different IOLs were detected for the levels of defocus from -4.00 to -1.00 diopters (D) (P < .01). Significant correlations were found between the optical bench image quality metric results and logMAR visual acuity scale in all groups (Lentis Mplus group: r = -0.97, P < .01; FineVision group: r = -0.82, P < .01; Acrys of group: r = -0.99, P < .01). Linear predicting models were obtained. CONCLUSIONS: Significant correlations were found between logMAR visual acuity and image quality metric for the multifocal and monofocal IOLs analyzed. This finding enables surgeons to predict visual outcomes from the optical bench analysis.

Corneal inlays for presbyopia correction.

PURPOSE OF REVIEW: This study provides an overview of the three types of corneal inlays now in use for the correction of presbyopia and reviews recently published evidence of the inlays' safety and efficacy. RECENT FINDINGS: Results for corneal reshaping and refractive inlays are promising, but very limited. Small-aperture inlays are already in widespread use and have been shown to improve uncorrected near and intermediate vision without a significant loss in distance acuity or an unacceptable increase in visual symptoms. Complications have been minimal, but the inlays may be removed if necessary. They do not prevent visualization or imaging of the retina and may be retained during subsequent cataract surgery. SUMMARY: The presbyopic demographic is large and growing, with a high level of interest in spectacle independence. There is currently no other effective solutions for presbyopes who desire good uncorrected vision at all distances without the risks of intraocular surgery or the visual compromises of monovision. Additional research is needed, but the future for corneal inlay technology is bright.

Aspheric wavefront-guided versus wavefront-guided LASIK for myopic astigmatism with the Technolas 217z100 excimer laser.

PURPOSE: To compare clinical outcomes of wavefront-guided LASIK with and without aspheric compensation in myopic eyes. METHODS: In this observational, single-center study, 134 eyes were treated using an aspheric module in combination with wavefront-guided profiles (PTA-algorithm) and compared to 146 eyes treated with the predecessor wavefront-guided software (APT) that has no aspheric compensation. All treatment plans included the Rochester nomogram that accounts for the preoperative manifest refraction and interaction of higher order aberrations. Active eye-tracking (including cyclorotational movements) was utilized during photoablation. RESULTS: Results at the 3-month follow-up: 67 % of PTA-treated eyes and 39 % of APT-treated eyes achieved an uncorrected distance visual acuity (UDVA) of 20/20 or better. Change in mean higher order aberration root-mean-square (HOA RMS) after PTA treatments was not statistically significant (p = 0.18). The increase in HOA RMS after APT treatments was statistically significant (p = 0.003). Change in mean postop spherical aberration (SA) after PTA treatments was not statistically significant (p = 0.27). The change in SA after APT treatments was statistically significant (p = 0.001). In both cohorts, mean uncorrected low-contrast visual acuity was statistically not different to preoperative corrected values. CONCLUSIONS: Adding an aspheric compensation to wavefront-guided myopic LASIK statistically improved clinical results in terms of visual acuity and refractive outcomes. Low-contrast visual acuity was not negatively affected in either group. While in APT-treated eyes mean HOA RMS and mean SA were significantly increased postoperatively, PTA-treated eyes showed neither induced HOA RMS nor induced SA.

Blocking Mitochondrial Pyruvate Transport Alters Corneal Myofibroblast Phenotype: A New Target for Treating Fibrosis.

Purpose: The purpose of this study was to critically test the hypothesis that mitochondrial pyruvate carrier (MPC) function is essential for maintenance of the corneal myofibroblast phenotype in vitro and in vivo. Methods: Protein and mRNA for canonical profibrotic markers were assessed in cultured cat corneal myofibroblasts generated via transforming growth factor (TGF)-ß1 stimulation and treated with either the thiazolidinedione (TZD) troglitazone or the MPC inhibitor alpha-cyano-beta-(1-phenylindol-3-yl) acrylate (UK-5099). RNA sequencing was used to gain insight into signaling modules related to instructive, permissive, or corollary changes in gene expression following treatment. A feline photorefractive keratectomy (PRK) model of corneal wounding was used to test the efficacy of topical troglitazone at reducing α-smooth muscle actin (SMA)-positive staining when applied 2 to 4 weeks postoperatively, during peak fibrosis. Results: Troglitazone caused cultured myofibroblasts to adopt a fibroblast-like phenotype through a noncanonical, peroxisome proliferator-activated receptor (PPAR)-γ-independent mechanism. Direct MPC inhibition using UK-5099 recapitulated this effect, but classic inhibitors of oxidative phosphorylation (OXPHOS) did not. Gene Set Enrichment Analysis (GSEA) of RNA sequencing data converged on energy substrate utilization and the Mitochondrial Permeability Transition pore as key players in myofibroblast maintenance. Finally, troglitazone applied onto an established zone of active fibrosis post-PRK significantly reduced stromal α-SMA expression. Conclusions: Our results provide empirical evidence that metabolic remodeling in myofibroblasts creates selective vulnerabilities beyond simply mitochondrial energy production, and that these are critical for maintenance of the myofibroblast phenotype. For the first time, we provide proof-of-concept data showing that this remodeling can be exploited to treat existing corneal fibrosis via inhibition of the MPC.

Contribution of optical zone decentration and pupil dilation on the change of optical quality after myopic photorefractive keratectomy in a cat model.

PURPOSE: To simulate the simultaneous contribution of optical zone decentration and pupil dilation on retinal image quality using wavefront error data from a myopic photorefractive keratectomy (PRK) cat model. METHODS: Wavefront error differences were obtained from five cat eyes 19+/-7 weeks (range: 12 to 24 weeks) after spherical myopic PRK for -6.00 diopters (D) (three eyes) and -10.00 D (two eyes). A computer model was used to simulate decentration of a 6-mm sub-aperture relative to the measured wavefront error difference. Changes in image quality (visual Strehl ratio based on the optical transfer function [VSOTF]) were computed for simulated decentrations from 0 to 1500 mum over pupil diameters of 3.5 to 6.0 mm in 0.5-mm steps. For each eye, a bivariate regression model was applied to calculate the simultaneous contribution of pupil dilation and decentration on the pre- to postoperative change of the log VSOTF. RESULTS: Pupil diameter and decentration explained up to 95% of the variance of VSOTF change (adjusted R(2)=0.95). Pupil diameter had a higher impact on VSOTF (median beta=-0.88, P<.001) than decentration (median beta=-0.45, P<.001). If decentration-induced lower order aberrations were corrected, the impact of decentration further decreased (beta=-0.26) compared to the influence of pupil dilation (beta=-0.95). CONCLUSIONS: Both pupil dilation and decentration of the optical zone affected the change of retinal image quality (VSOTF) after myopic PRK with decentration exerting a lower impact on VSOTF change. Thus, under physiological conditions pupil dilation is likely to have more effect on VSOTF change after PRK than optical zone decentration.

Higher-order aberrations after implantation of iris-fixated rigid or foldable phakic intraocular lenses.

PURPOSE: To evaluate higher-order aberrations (HOAs) after implantation of Artiflex phakic intraocular lenses (pIOLs). SETTING: Department of Ophthalmology, Academic Hospital Maastricht, Maastricht, The Netherlands. METHODS: This retrospective comparative case series comprised 27 eyes (14 patients) that had Artiflex pIOL implantation and 22 eyes (13 patients) that had Artisan pIOL implantation. Refractive data, pupil size, IOL decentration, and HOA values were recorded and compared. Laboratory analysis was performed. Follow-up was 1 year. RESULTS: In the Artiflex group, the mean spherical equivalent (SE) changed from -9.95 diopters (D) +/- 1.43 (SD) (range -6.75 to -12.13 D) to -0.30 +/- 0.53 D (range -1.94 to 0.56 D). Postoperatively, trefoil-y increased (increase factor 1.73) and spherical aberration decreased (increase factor 0.55). The mean pIOL decentration was 0.24 +/- 0.12 mm; 96.3% were decentered 0.5 mm or less. There was a significant correlation between pIOL decentration and postoperative spherical aberration and coma-y. In the Artisan group, the mean SE changed from -9.90 +/- 2.74 D (range -4.00 to -14.50 D) to -0.20 +/- 0.42 D (range -0.75 to 0.50 D). Postoperatively, trefoil-y and spherical aberration increased (increase factors 3.32 and 6.84, respectively). Laboratory analysis confirmed the negative and positive spherical aberration profile of the Artiflex pIOL and Artisan pIOL, respectively. CONCLUSIONS: Artiflex pIOL implantation decreased spherical aberration, while Artisan pIOL implantation increased spherical aberration. Trefoil-y increased in both groups. These changes might be explained by incision size differences in relation to trefoil and differences in optic design in relation to spherical aberration.

The effect of optical zone decentration on lower- and higher-order aberrations after photorefractive keratectomy in a cat model.

PURPOSE: To simulate the effects of decentration on lower- and higher-order aberrations (LOAs and HOAs) and optical quality, by using measured wavefront error (WFE) data from a cat photorefractive keratectomy (PRK) model. METHODS: WFE differences were obtained from five cats' eyes 19 +/-7 weeks after spherical myopic PRK for -6 D (three eyes) and -10 D (two eyes). Ablation-centered WFEs were computed for a 9.0 mm pupil. A computer model was used to simulate decentration of a 6-mm subaperture in 100-microm steps over a circular area of 3000 microm diameter, relative to the measured WFE difference. Changes in LOA, HOA, and image quality (visual Strehl ratio based on the optical transfer function; VSOTF) were computed for simulated decentrations over 3.5 and 6.0 mm. RESULTS: Decentration resulted in undercorrection of sphere and induction of astigmatism; among the HOAs, decentration mainly induced coma. Decentration effects were distributed asymmetrically. Decentrations >1000 microm led to an undercorrection of sphere and cylinder of >0.5 D. Computational simulation of LOA/HOA interaction did not alter threshold values. For image quality (decrease of best-corrected VSOTF by >0.2 log units), the corresponding thresholds were lower. The amount of spherical aberration induced by the centered treatment significantly influenced the decentration tolerance of LOAs and log best corrected VSOTF. CONCLUSIONS: Modeling decentration with real WFE changes showed irregularities of decentration effects for rotationally symmetric treatments. The main aberrations induced by decentration were defocus, astigmatism, and coma. Treatments that induced more spherical aberration were less tolerant of decentration.