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.

Results of the United States Food and Drug Administration Clinical Trial of the CustomFlex Artificial Iris.

PURPOSE: To evaluate safety and efficacy of a custom-manufactured artificial iris device (CustomFlex Artificial Iris; HumanOptics AG) for the treatment of congenital and acquired iris defects. DESIGN: Multicenter, prospective, unmasked, nonrandomized, interventional clinical trial. PARTICIPANTS: Patients with photophobia, sensitivity secondary to partial or complete congenital or acquired iris defects, or both. METHODS: Eyes were implanted from November 26, 2013, to December 1, 2017, with a custom, foldable artificial iris by 1 of 4 different surgical techniques. Patients were evaluated 1 day, 1 week, and 1, 3, 6, and 12 months after surgery. At each examination, slit-lamp findings, intraocular pressure, implant position, subjective visual symptoms, and complications were recorded. Corrected distance visual acuity (CDVA) and endothelial cell density (ECD) were measured at 3, 6, or 12 months as additional safety evaluations. The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) was used to assess health-related quality of life affected by vision. The Global Aesthetic Improvement Scale was used to assess cosmetic results. MAIN OUTCOME MEASURES: Photosensitivity, glare, visual symptoms, NEI VFQ-25 score, Global Aesthetic Improvement Scale rating, prosthesis-related adverse events, intraocular lens (IOL)-related adverse events, and surgery-related adverse events 12 months after surgery. RESULTS: At the 12-month postoperative examination, a 59.7% reduction in marked to severe daytime light sensitivity (P < 0.0001), a 41.5% reduction in marked to severe nighttime light sensitivity (P < 0.0001), a 53.1% reduction in marked to severe daytime glare (P < 0.0001), and a 48.5% reduction in severe nighttime glare (P < 0.0001) were found. A 15.4-point improvement (P < 0.0001) in the NEI VFQ-25 total score was found, and 93.8% of patients reported an improvement in cosmesis as measured by the Global Aesthetic Improvement Scale 12 months after surgery. No loss of CDVA of > 2 lines related to the device was found. Median ECD loss was 5.3% at 6 months after surgery and 7.2% at 12 months after surgery. CONCLUSIONS: The artificial iris surpassed all key safety end points for adverse events related to the device, IOL, or implant surgery and met all key efficacy end points, including decreased light and glare sensitivity, improved health-related quality of life, and satisfaction with cosmesis. The device is safe and effective for the treatment of symptoms and an unacceptable cosmetic appearance created by congenital or acquired iris defects.

Pseudophakic Dysphotopsia: Review of Incidence, Cause, and Treatment of Positive and Negative Dysphotopsia.

We reviewed the literature concerning positive dysphotopsia (PD) and negative dysphotopsia (ND) regarding cause, incidence, and clinical and surgical management. In addition, we summarized our surgical experience in managing dysphotopsia. A PubMed review, limited to English language articles, yielded 149 citations; multifocal (diffractive optic) and phakic intraocular lens (IOL) dysphotopsia were excluded. Overall, 39 articles were determined to be relevant for the objectives of this investigation. Regarding PD, 7 articles corroborated that the cause of PD is related primarily to internal reflection of oblique light rays that strike the square (truncated) edge of the IOL and are reflected onto the retinal surface. No round-edged foldable IOLs are available in the United States at this time, although IOLs modified with a round anterior edge and square posterior edge show a trend toward decreased incidence of PD. High index of refraction (I/R), surface reflectivity, and IOL optic design are additional causative factors for PD. Regarding the authors' surgical experience, changing the optic material to have a lower I/R improved PD symptoms in the large majority of patients. The cause of ND seems to be multifactorial and less well understood, with some disparity between clinical and laboratory findings. Four articles that explore using ray-tracing optical modeling suggest an "illumination gap," in which some temporally incident light rays to the nasal retina pass anterior to the IOL and some are refracted posteriorly by the IOL, resulting in a gap and resultant temporal shadow. However clinically, ND is associated invariably with well-centered in-the-bag IOLs. Other implicating factors include nasal anterior capsule override, haptic orientation, large-angle κ value, and high hyperopia. Persistent ND has been treated successfully or reduced with reverse (anterior) optic capture, sulcus IOL placement, piggyback IOLs, and neodymium:yttrium-aluminum-garnet nasal capsulectomy. Two articles reference a new optic edge designed to capture the anterior capsulotomy, mimicking reverse optic capture. Persistent dysphotopsia after cataract surgery is a significant cause for patient dissatisfaction. The cause and management of both ND and PD are of significance, and new IOL designs and alternative surgical strategies may help to mitigate these unintended side effects of IOL implantation.

Comparison of Intraoperative Aberrometry, OCT-Based IOL Formula, Haigis-L, and Masket Formulae for IOL Power Calculation after Laser Vision Correction.

PURPOSE: To compare the accuracy of intraoperative aberrometry technology and the Fourier-domain optical coherence tomography (OCT)-based intraocular lens (IOL) formula for IOL power calculation in eyes undergoing cataract surgery after previous laser vision correction (LVC) compared with established methods. DESIGN: Retrospective consecutive case series. PARTICIPANTS: Patients undergoing cataract surgery with a history of LASIK or photorefractive keratectomy. METHODS: The IOL power was estimated preoperatively using the IOLMaster 500 (Carl Zeiss Meditec, Dublin, CA) to calculate the Haigis-L and Masket regression formulae (when prior data were available), and the Optovue RTVue (Optovue Inc, Fremont, CA) spectral domain OCT was used to obtain the Fourier-domain OCT-based IOL formula. The Optiwave Refractive Analysis (ORA) System (WaveTec Vision Systems Inc, Aliso Viejo, CA) wavefront aberrometer measured aphakic refractive measurements intraoperatively and calculated the IOL power with a modified vergence formula. Comparative analysis was done for predictive accuracy of IOL power determination using 2 conventional methods and 2 new technologies: the Haigis-L formula, Masket regression formula, ORA intraoperative aberrometry, and Optovue RTVue Fourier-domain OCT-based IOL formula. Patients without historical data (N = 39) were compared using 3 methods (Haigis-L, ORA, and Optovue), and patients with historical data (N = 20) were compared using all methods (Masket regression formula, Haigis-L, ORA, and Optovue). MAIN OUTCOME MEASURES: Median absolute error (MedAE), mean absolute error (MAE), and percentage of eyes within ±0.25, ±0.50, ±0.75, and ±1.00 diopters (D) of refractive prediction error. RESULTS: A total of 39 eyes of 29 patients without historical data were analyzed separately from 20 eyes of 20 patients with historical data. In the group without historical data (N = 39), 49% of eyes were within ±0.25 D, 69% to 74% of eyes were within ±0.50 D, 87% to 97% of eyes were within ±0.75 D, and 92% to 97% of eyes were within ±1.00 D of targeted refractive IOL power prediction error. The MedAE was 0.26 D for Haigis-L, 0.29 D for ORA, and 0.28 D for Optovue. The MAE was 0.37 D for Haigis-L, 0.34 D for ORA, and 0.39 D for Optovue. In the group with historical data (N = 20), 35% to 70% of eyes were within ±0.25 D, 60% to 85% of eyes were within ±0.50 D, 80% to 95% of eyes were within ±0.75 D, and 90% to 95% of eyes were within ±1.00 D of targeted refractive IOL power prediction error. The MedAE was 0.21 D for the Masket regression formula, 0.22 D for the Haigis-L formula, 0.25 D for ORA, and 0.39 for Optovue. The MAE was 0.28 D for the Masket regression formula, 0.31 D for the Haigis-L formula, 0.37 D for ORA, and 0.44 D for Optovue. There was no statistically significant difference among the methods. CONCLUSIONS: Newer technology to estimate IOL power calculations in eyes after LVC shows promising results when compared with established methods.

Evaluation of a New Controlled Point Source LED Glare Tester for Disability Glare Detection in Participants With and Without Cataracts.

PURPOSE: To determine glare-induced change during visual acuity testing in patients with and without cataract using the controlled point source light-emitting diode (LED) glare tester (EpiGlare Tester; Epico, LLC, Columbus, OH), a new medical device for identification of glare disability. METHODS: This prospective, multicenter study enrolled 40 patients (80 eyes with cataracts) and 49 control subjects (98 eyes without cataracts). Corrected distance visual acuity (CDVA) was measured with and without glare using the EpiGlare Tester as a glare source. Functional visual ability was evaluated using driving and glare subscales from the Refractive Status Vision Profile questionnaire. The primary efficacy measure was change in CDVA measurement with and without glare in patients with senile cataract compared to participants without cataract. Secondary efficacy measures included correlation of the CDVA change caused by functional glare disability and subjective patient and investigator assessments. RESULTS: CDVA reduction was greater for patients with cataract, with a mean reduction of -0.49 ± 0.3 logMAR, than for participants without cataracts at -0.13 ± 0.2 logMAR (P < .001). This equates to a 5-line Snellen reduction (0.49 logMAR) in patients with cataracts and a 1-line reduction (-0.13 logMAR) in patients without cataracts. Among patients with cataracts, 83% stated the device accurately represented the difficulty experienced while driving at night (P < .001); among participants without cataracts, 71% reported being minimally affected by glare from the device (P = .003). CONCLUSIONS: A new controlled point source LED glare tester demonstrated the adverse effect on visual acuity due to glare in patients with cataract, accurately simulated night driving glare issues for patients with cataracts, and was rated as easy to use and useful by investigators.

Epidemiology of Consumer-Product-Related Ocular Injuries in the Geriatric Population in the United States.

INTRODUCTION: The purpose of this study was to assess trends in consumer-product-related geriatric ocular injuries using National Electronic Injury Surveillance System (NEISS) data. Understanding the specific consumer products and settings coded in the NEISS dictionary that contribute to geriatric (≥ 65 years) ocular injuries, along with changing patterns during events like the COVID-19 pandemic, provides crucial insights for tailoring therapy and preventative strategies. This ultimately may reduce the burden of eye injuries on both older adults and healthcare systems. METHODS: This was a retrospective population-based cohort study. The NEISS database was used to study eye injuries in geriatric adults from 2010 to 2021. Patients were categorized by age groups (65-74, 75-84, 85-94, ≥ 95 years), and data on demographics, injury types, product categories, and COVID-19 impact were collected. Pearson's chi-squared test (with p < 0.001 taken to indicate significance) was used to assess differences in expected ratios between age groups. RESULTS: A total of 168,685 eye injury cases in adults aged 65 years and older were analyzed. Household items, tools, and gardening products accounted for over 75% of injuries. Most injuries occurred at home (65.3%). Contusions/abrasions (40.3%) and a foreign body (19.3%) were common diagnoses. Females had more household-item-related injuries, while males had more foreign body injuries. Regarding therapeutic disposition, 93.7% of all injuries were treated/examined and released, which showed a decreasing trend as age increased, while hospital admission/transfer rates increased with age. Compared to before COVID-19, the percentage of injuries during COVID-19 due to tools decreased (from 22.5% to 18.3%), while injuries due to gardening/lawn/landscaping/patio products increased (from 13.8% to 15.3%). CONCLUSIONS: Our study characterizes geriatric ocular injuries and COVID-19 impact, highlighting common products and locations. Different age groups showed different injury patterns. Understanding these trends can aid injury prevention strategies for consumers and healthcare providers. Demographics and injury frequencies differed based on age and sex. Future research should further explore post-COVID-19 trends.

Surgical outcomes of intraocular lens iris suture fixation in eyes with residual capsule support.

PURPOSE: To evaluate the safety and refractive outcomes of eyes after intraocular lens (IOL) iris suture fixation (ISF). SETTING: Private practice, Los Angeles, California. DESIGN: Nonrandomized and unmasked retrospective chart review. METHODS: Eyes that underwent IOL exchange or repositioning with ISF with at least 270 degrees of capsular support were included. Eyes with less than 270 degrees of capsular support and eyes with iris damage were excluded. The primary outcome measures included incidence of cystoid macular edema (CME), IOL dislocation requiring refixation, and chronic inflammation. Secondary outcome measures included worsening intraocular pressure (IOP) control, retinal tear or detachment, worsening of corrected distance visual acuity (CDVA), and corneal decompensation. Refractive outcomes for 26 subgrouped eyes included mean and median spherical equivalent refraction accuracy (SERA), and percentage of eyes within 0.5 diopter (D) and 1 D of the refractive target. RESULTS: The study included 53 eyes of 50 patients. CME: 2/53 (3.8%), IOL dislocation requiring refixation: 2/53 (3.8%), chronic inflammation: 1/53 (1.9%), worsening IOP control: 5/53 (9.4%), retinal tear or detachment: 2/53 (3.8%). No patient experienced worsening of CDVA from baseline or corneal decompensation. Mean SERA ± SD -0.35 ± 0.29 D, median SERA -0.37 D. Of the 26 eyes subgrouped for refractive analysis, 73% were within 0.5 D and 100% were within 1 D of the desired refractive outcome. CONCLUSIONS: ISF can offer stability for sulcus-fixated IOLs provided there is some residual capsule support. Although there are measurable complications, there is a relatively low side effect profile. The refractive error tended to be myopic, indicating the need for further refinement of IOL power predictive formulas.

Scleral fixation of a one-piece toric intraocular lens.

PURPOSE: To describe a novel technique for toric intraocular lens (IOL) repositioning and fixation in the absence of adequate capsular support. METHODS: Case report and literature review. RESULTS: Two cases are presented with scleral fixation of a one-piece toric IOL (SN6AT series; Alcon Laboratories, Inc., Fort Worth, TX). In both cases, toric IOLs initially placed within the capsular bag became decentered due to poor capsular support. To avoid the potential complications of lens explantation and maintain the astigmatic benefits of the toric IOL, scleral fixation of the lenses was performed. The Hoffman technique was used to create reverse scleral pockets without conjunctival dissection. A 10-0 non-dissolvable suture was used to capture and then secure the lens haptics in a lasso-type fashion. Sutures were then buried within the previously created scleral pockets. Both patients had well-centered lenses postoperatively that remained stable at last follow-up, 30 months postoperatively. CONCLUSION: In the absence of adequate capsular support, scleral fixation is a viable option for one-piece toric IOL fixation to avoid IOL explantation.

Prospective multicenter study of toric IOL outcomes when dual zone automated keratometry is used for astigmatism planning.

PURPOSE: To evaluate clinical outcomes when toric intraocular lens (IOL) calculations are based on the keratometric output from the Lenstar LS-900 dual zone automated keratometer (Haag-Streit AG, Koeniz, Switzerland). METHODS: Eligible subjects presenting for toric IOL implantation at five sites were measured with a dual-zone automated keratometer. The data were used to plan the power and angle of the toric IOL to be implanted. Refractive and visual acuity status were checked at 1 and 3 months postoperatively. RESULTS: A total of 102 eyes had relevant data for analysis. More than 76% of eyes had 0.50 diopter or less of refractive astigmatism at 1 and 3 months, with no difference by level of astigmatism corrected. More than half of the eyes had uncorrected distance visual acuity of 20/20 or better and 78% were 20/25 or better. A new measure of effectiveness of toric correction power is described that suggested lens selection was appropriate. Results appeared better than those obtained in previous studies when the IOL cylinder power and alignment were calculated using manual keratometry. CONCLUSIONS: In this series of eyes from multiple centers, the calculation of toric IOL power using dual-zone automated keratometry measurements produced clinical results that were better than results in the literature where manual keratometry was used.

Clinical outcomes and complications following intraocular lens exchange in the setting of an open or intact posterior capsule.

PURPOSE: To assess whether there are added risks when performing intraocular lens (IOL) exchange in the setting of an open posterior capsule (OPC) when compared with a closed posterior capsule (CPC) IOL exchange. SETTING: Private practice, Los Angeles, California. DESIGN: Nonrandomized and unmasked retrospective chart review. METHODS: Eyes undergoing IOL exchange solely to relieve optical symptoms, with open or intact posterior capsules, were included. Eyes undergoing IOL exchange due to IOL malposition or dislocation were excluded. Eyes with preexisting, uncontrolled glaucoma and inflammation and eyes with a visual potential worse than 20/40 (Snellen) were also excluded. The main outcome measures were the postoperative complications compared between the OPC and CPC groups. RESULTS: 90 eyes of 75 patients undergoing IOL exchange were included in this study; 38/90 eyes had an OPC, and 52/90 eyes had a CPC. 3/38 in the OPC group and 2/52 in the CPC group experienced worsening intraocular pressure control. 1/38 in the OPC group experienced chronic inflammation. 2/38 in the OPC group and 2/52 in the CPC group experienced cystoid macular edema. 1/52 in the CPC group experienced a retinal tear. Statistically or clinically significant differences in postoperative complications between the OPC and CPC groups were not found. CONCLUSIONS: In the hands of an experienced surgeon, IOL exchange with an OPC appear red to be just as safe as IOL exchange with a CPC; when deemed necessary, experienced surgeons may perform an IOL exchange safely in the presence of an OPC.

Capsular phimosis with intraocular lens tilt and decentration.

A 34-year-old woman with quiescent bilateral intermediate uveitis maintained on once-daily dexamethasone 0.1% eyedrops, complicated by left cataract and glaucoma controlled with a single antiglaucoma medication, presented for cataract surgery. Her left corrected distance visual acuity (CDVA) was 20/40 because of a posterior subcapsular lens opacity. The anterior chamber angles appeared closed in all 4 quadrants on gonioscopy. Ultrasound biomicroscopy (UBM) confirmed the gonioscopy findings and, in addition, revealed a crystalline lens thickness of 5.53 mm, normal ciliary body structure, and multiple localized chorioretinal scars with membranes over the pars plana region. She underwent left phacoemulsification, goniosynechiolysis, and in-the-bag implantation of a single-piece monofocal hydrophobic acrylic intraocular lens (IOL). On the first postoperative day, she achieved pinhole vision of 20/70 (-6 diopters [D] myopia to balance with the fellow eye). There was mild anterior chamber cellular activity and flare, consistent with postoperative inflammation. Her intraocular pressure (IOP) was 16 mm Hg without antiglaucoma therapy. She was advised to continue the prednisolone acetate 1% eyedrops 6 times daily and to reduce it to 4 times daily after a week for the next 4 weeks. At 1 month, she was refracted to 20/40 N5, and the eye was quiescent. Optical coherence tomography showed that the macular was normal. The topical steroids were gradually tapered to the preoperative level. However, a month later, she returned complaining of deteriorating vision while using twice-daily steroid eyedrops. Her CDVA was 20/60. Slitlamp examination revealed anterior capsule fibrosis and capsular phimosis, resulting in partial obstruction of the visual axis and mild decentration of the IOL superior temporally (Figure 1JOURNAL/jcrs/04.03/02158034-202310000-00013/figure1/v/2023-09-28T161738Z/r/image-tiff). The anterior segment was quiescent. The pupil could only be dilated to 4.5 mm despite the absence of posterior synechiae. Fundus examination revealed a normal-looking quiescent posterior segment. Her IOP was 16 mm Hg. UBM showed a thickened anterior capsule, intact zonular fibers, and a posteriorly bowed and decentered IOL within the capsular bag (Figure 2JOURNAL/jcrs/04.03/02158034-202310000-00013/figure2/v/2023-09-28T161738Z/r/image-tiff). She was referred for further management. Discuss how you would manage this problem, explaining your decisions. How would you be able to avoid the same problem when operating on her fellow eye?