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.

Accuracy of Intraocular Lens Calculation Formulas.

PURPOSE: To compare the accuracy of intraocular lens (IOL) calculation formulas (Barrett Universal II, Haigis, Hoffer Q, Holladay 1, Holladay 2, Olsen, and SRK/T) in the prediction of postoperative refraction using a single optical biometry device. DESIGN: Retrospective consecutive case series. PARTICIPANTS: A total of 13 301 cataract operations with an AcrySof SN60WF implant and 5200 operations with a SA60AT implant (Alcon Laboratories, Inc., Fort Worth, TX). METHODS: All patients undergoing cataract surgery between July 1, 2014, and December 31, 2015, with Lenstar 900 optical biometry were eligible. A single eye per patient was included in the final analysis, resulting in a total of 18 501 cases. We compared the performance of each formula with respect to the error in predicted spherical equivalent and evaluated the effect of applying the Wang-Koch (WK) adjustment for eyes with axial length >25.0 mm on 4 of the formulas. RESULTS: For the SN60WF, the standard deviation of the prediction error, in order of lowest to highest, was the Barrett Universal II (0.404), Olsen (0.424), Haigis (0.437), Holladay 2 (0.450), Holladay 1 (0.453), SRK/T (0.463), and Hoffer Q (0.473), and the results for the SA60AT were similar. The Barrett formula was significantly better than the other formulas in postoperative refraction prediction (P < 0.01) for both IOL types. Application of the WK axial length modification generally resulted in a shift from hyperopic to myopic outcomes in long eyes. CONCLUSIONS: Overall, the Barrett Universal II formula had the lowest prediction error for the 2 IOL models studied.

Optimum pinhole size determination in pinhole pupilloplasty for higher-order aberrations.

PURPOSE: To determine optimal pinhole size (OPS) and establish a relationship with visual acuity (VA) and RMS (root mean square) values in cases with higher-order aberrations (HOAs) undergoing pinhole pupilloplasty (PPP). SETTING: Private practice, India. DESIGN: Prospective, interventional study. METHODS: RMS value for 6-mm-diameter optical zone was determined by Scheimpflug imaging (Pentacam). Patients with RMS value >0.3 µm were included. Preoperatively, a hand-held pinhole gauge with varied apertures determined the OPS, and single-pass four-throw technique was used to perform pupilloplasty with Purkinje-1 reflex as a marker for centration. VA with OPS, correlation of RMS values with OPS and pupil size, and Strehl ratio were the main outcome measures. RESULTS: 29 eyes with HOAs were analyzed; all patients chose 1.0 or 1.5 mm as OPS. The mean preoperative and postoperative pupil size was 3.25 ± 0.81 mm and 1.8 ± 0.54 mm ( P = .000), respectively. Postoperative mean pupil size when compared with OPS denoted that 14 eyes had a difference of <0.1 mm, 8 eyes ranged from 0.2 to 0.45 mm, and 7 eyes had ≥0.6 mm (range from 0.6 to 1.8 mm) difference from OPS. Eyes with higher RMS values needed smaller pupil gauge to achieve better VA. Preoperatively, vision with OPS correlated well with preoperative 6-mm RMS HOAs ( r = 0.728; P = .00). Postoperative UDVA correlated well with VA measured with OPS ( r = 0.847; P = .00). The preoperative and postoperative mean Strehl ratio was 0.109 ± 0.07 and 0.195 ± 0.11 ( P = .001), respectively. CONCLUSIONS: Higher RMS values required a smaller pupil to achieve optimum VA. PPP can help achieve pinhole size in accordance with patient's optimum pinhole requirement.

Argon laser iridoplasty to improve visual function following multifocal intraocular lens implantation.

PURPOSE: To describe the use of argon laser iridoplasty following implantation of a multifocal intraocular lens (IOL) to improve visual function. METHODS: Argon laser spots of 500-mW power, 500-µm spot diameter, and 500-ms duration were placed in the midperipheral iris in the area in which the iris was encroaching on the IOL. RESULTS: Argon laser iridoplasty provided statistically significant improvement in visual function including corrected distance visual acuity (CDVA) and subjective quality of vision in 14 eyes from 11 patients. Mean CDVA improved from 0.24 (20/35 Snellen) to 0.10 (20/25 Snellen) logMAR (P<.0001), and mean subjective quality of vision improved from 2.9 to 7.5 (P<.0001). CONCLUSIONS: Argon laser iridoplasty should be considered in correcting visual problems associated with decentered multifocal IOLs.

A contralateral, randomized comparison of optimized prolate ablation and conventional LASIK for myopia with the NIDEK excimer laser platform.

PURPOSE: To compare the refractive, visual acuity, topographic, and spherical aberration outcomes of LASIK using the Quest excimer laser platform with the optimized prolate ablation (OPA) profile (NIDEK Co Ltd) in one eye and conventional ablation profile in the fellow eye of the same patient. METHODS: Thirty-seven myopic patients underwent LASIK bilaterally, with one eye randomized to receive OPA ablation (-3.88±1.42 diopters [D], range: -1.53 to -7.50 D) and the fellow eye to receive conventional ablation (-3.89±1.37 D, range: -1.75 to -7.00 D). Independent and paired t tests were used for testing differences between groups at last postoperative follow-up (6 or 12 months). RESULTS: Postoperatively, 97% (32/33) of OPA eyes and 94% (31/33) of conventional eyes saw 20/20 or better without correction (P>.05). No eyes lost 2 or more lines of distance corrected visual acuity. Manifest refraction spherical equivalent was -0.16 D in the OPA group and -0.05 D in the conventional group (P>.05). Ocular spherical aberration was -0.003 µm in the OPA group and +0.102 µm in the conventional group (P<.05). Corneal asphericity was statistically lower after OPA (0.07±0.26) compared to conventional ablation (0.30±0.26) (P<.001). The mean programmed optical zone and achieved postoperative horizontal diameter of the effective optical zone were statistically significantly larger in the OPA group (P<.05). CONCLUSIONS: Postoperative visual acuity and refractive outcomes were similar between groups. Laser in situ keratomileusis using the OPA profile for the correction of myopia induced significantly less corneal and ocular spherical aberration, resulted in normal postoperative asphericity in 94% of eyes, and larger horizontal diameter of the effective optical zone compared to the conventional profile.

Astigmatism analysis and reporting of surgically induced astigmatism and prediction error.

PURPOSE: To provide a method for determining the vector that, when added to the preoperative astigmatism, results in no prediction error (PE) and to specify statistical methods for evaluating astigmatism and determining the 95% confidence convex polygon. SETTING: Baylor College of Medicine, Houston, Texas, and University of Southern California, Los Angeles, California. DESIGN: Retrospective consecutive case series. METHODS: An analysis of 3 clinical trials involving toric intraocular lenses was performed. 3 formulas were evaluated (generic vergence formula with zero surgically induced astigmatism, the Barrett toric formula, and the Holladay toric formula). Scalar and vector analyses were performed on each dataset with each formula and the results compared. Since the PE was not a Gaussian distribution, a 95% convex polygon was used to determine the spread of the data. RESULTS: The mean values for the vector absolute astigmatism PEs were not different for the 3 formulas and 3 datasets. The Barrett and Holladay toric calculators were statistically superior to the zero formula for 3 intervals (0.75, 1.0, and 1.25) in the high astigmatism dataset. CONCLUSIONS: Residual astigmatism and vector absolute astigmatism PE mean values and SDs are useful but require extremely large datasets to demonstrate a statistical difference, whereas examining percentages in 0.25 diopters (D) steps from 0.25 to 2.0 D reveals differences with far fewer cases using the McNemar test for a P value. Double-angle plots are especially useful to visualize astigmatic vector PEs, and a 95% confidence convex polygon should be used when distributions are not Gaussian.

Use of P1-P4 Purkinje reflections as a surrogate sign for intraoperative patient fixation.

Circumferential, even anterior capsular overlap maximizes intraocular lens stability and posterior capsular opacification mitigation and provides best long-term outcomes for the cataract patient. P1 and P4 Purkinje reflections at patient fixation may provide a reliable marker for capsulotomy centration. However, patient fixation may be hindered during surgery because of anesthesia or light sensitivity. In this study, we demonstrate that the relationship between the P1 and P4 Purkinje reflections previewed prior to surgery when the patient is fixating may be recreated intraoperatively if fixation becomes difficult. The final position of P1 and P4 relative to one another at fixation is invariant in a given patient, but there are variations among patients. Knowledge of the P1 and P4 relationship can be used as a surrogate sign of patient fixation to assist in capsulotomy centration during cataract surgery.

Review and recommendations for univariate statistical analysis of spherical equivalent prediction error for IOL power calculations.

PURPOSE: To provide a reference for study design comparing intraocular lens (IOL) power calculation formulas, to show that the standard deviation (SD) of the prediction error (PE) is the single most accurate measure of outcomes, and to provide the most recent statistical methods to determine P values for type 1 errors. SETTING: Baylor College of Medicine, Houston, Texas, and University of Southern California, Los Angeles, California, USA. DESIGN: Retrospective consecutive case series. METHODS: Two datasets comprised of 5200 and 13 301 single eyes were used. The SDs of the PEs for 11 IOL power calculation formulas were calculated for each dataset. The probability density functions of signed and absolute PE were determined. RESULTS: None of the probability distributions for any formula in either dataset was normal (Gaussian). All the original signed PE distributions were not normal, but symmetric and leptokurtotic (heavy tailed) and had higher peaks than a normal distribution. The absolute distributions were asymmetric and skewed to the right. The heteroscedastic method was much better at controlling the probability of a type I error than older methods. CONCLUSIONS: (1) The criteria for patient and data inclusion were outlined; (2) the appropriate sample size was recommended; (3) the requirement that the formulas be optimized to bring the mean error to zero was reinforced; (4) why the SD is the single best parameter to characterize the performance of an IOL power calculation formula was demonstrated; and (5) and using the heteroscedastic statistical method was the preferred method of analysis was shown.

Effect of Cyclosporine 0.09% Treatment on Accuracy of Preoperative Biometry and Higher Order Aberrations in Dry Eye Patients Undergoing Cataract Surgery.

PURPOSE: To determine the effect of topical cyclosporine 0.09% on ocular surface regularity and the predictive accuracy of preoperative corneal power measurements in patients undergoing cataract surgery. SETTING: Private practice. DESIGN: Open-label, multicenter, prospective study. METHODS: Seventy-five patients (75 eyes) who presented for cataract surgery evaluation with signs of dry eye disease were prescribed topical cyclosporine 0.09% for 28 days BID. Corneal curvature measurements, slit lamp exam, and Standardized Patient Evaluation of Eye Dryness (SPEED) questionnaire were evaluated at the initial and follow-up visits. Cataract surgery occurred 1 to 3 weeks after the second biometry visit. Refraction and corrected distance visual acuity measurements were performed 1-month post-surgery. The primary outcome was the difference in absolute prediction error of 1-month spherical equivalent refractive outcome before and after cyclosporine treatment. Secondary outcomes included the effect of topical cyclosporine 0.09% on ocular surface irregularity. RESULTS: Sixty-four patients completed the study. The absolute prediction error of 1-month spherical equivalent refractive outcome was 0.39 ± 0.30 D vs 0.33 ± 0.25 D (P < 0.03) before and after treatment, respectively. The proportion of eyes that achieved the target refraction was greater based on measurements after topical cyclosporine 0.09% than would have occurred using pre-treatment measurements. CONCLUSION: Cataract surgery patients with dry eye who are prescribed topical cyclosporine 0.09% BID for 28 days pre-surgery showed a statistically significant improvement in the prediction error of the spherical equivalent outcome of surgery. Other measures of dry eye severity showed significant improvements after treatment.