William Ngo

Psychometric properties and validation of the Standard Patient Evaluation of Eye Dryness questionnaire.

Purpose: To characterize the psychometric properties of the standard patient evaluation of eye dryness (SPEED) questionnaire and to validate and compare its performance with 4 existing dry eye questionnaires. Methods: A total of 50 subjects (40 female and 10 male) were enrolled; of these, 30 were symptomatic and 20 asymptomatic, as determined using the ocular surface disease index (OSDI). This study consisted of 2 visits in which all subjects completed 5 different dry eye questionnaires (SPEED, OSDI, dry eye questionnaire, McMonnies dry eye questionnaire, and subjective evaluation of symptom of dryness) in random order at each visit. Clinical measurements were obtained on the first visit. Repeatability was determined using concordance correlation coefficient; dimensionality was determined using principal component, factor, and Rasch analyses; and validity was determined by comparing SPEED scores with dry eye diagnosis based on OSDI (primarily using receiver–operator curve analysis). Results: The SPEED questionnaire data were found to be unidimensional and repeatable. Three principal components (dryness, burning, and soreness/fatigue) were identified and SPEED between visit concordance correlation coefficient was 0.923 (95% confidence interval, 0.868–0.955). The area under the receiver–operator curves was 0.928. The only clinical measures that correlated “well” with SPEED questionnaire scores were corneal staining (P < 0.05), meibomian gland score (P < 0.05), and meibomian glands yielding liquid secretion score (P < 0.05). Conclusions: The SPEED questionnaire was shown to be a repeatable and valid instrument for measurement of dry eye symptoms. The SPEED score also correlated significantly with ocular surface staining and clinical measures of meibomian gland function.

Repeatability of grading meibomian gland dropout using two infrared systems.

Purpose To determine the interobserver and intraobserver repeatability in using the OCULUS Keratograph 4 (K4) and 5M (K5M) to grade meibomian gland (MG) dropout using meibography grading scales. Methods The inferior and superior eyelids of 40 participants (35 women, 5 men; mean age = 32 years) were imaged three times each on both instruments. The images were split into one training and two study sets; the latter were graded (four-point meibography scale) by two observers on two separate occasions (24 hours apart) to determine repeatability. Semiobjective quantification of percentage MG dropout was conducted using ImageJ on K4 and K5M images. A finer seven-point meibography scale was used to grade a separate set of K5M images. Results For the four-point scale, interobserver mean difference (MD) (±SD) was 0.08 (±0.55) on day 1 and 0.13 (±0.50) on day 2, and the concordance correlation coefficient (CCC) was 0.79 and 0.81 on days 1 and 2, respectively. Intraobserver MD (±SD) was 0.04 (±0.54), CCC = 0.79 for observer 1; intraobserver MD (±SD) was −0.09 (±0.60), CCC = 0.74 for observer 2. For the seven-point scale, interobserver MD (±SD) was 0.05 (±0.45), CCC = 0.89 on day 1, and interobserver MD (±SD) was 0.01 (±0.41), CCC = 0.91 on day 2. Intraobserver MD (±SD) was −0.10 (±0.35), CCC = 0.93 for observer 1, and intraobserver MD (±SD) was −0.06 (±0.30), CCC = 0.95 for observer 2. Percentage dropout measured between the K4 and K5M images showed lack of agreement, with 21.8% coefficient of repeatability. There was no significant correlation (r < 0.2; p > 0.05) between meibography score and clinical signs (corneal staining, gland expressibility, telangiectasia, vascularity, lash loss); however, there was a high correlation (r = 0.77; p < 0.05) between meibography score with percentage dropout. Conclusions Observers graded from −1 to +1 grade units between and within themselves for a four-point scale, 95% of the time. Although the interobserver and intraobserver repeatability of the K4 and K5M were very similar, a high rate of disagreement in percentage dropout between K4 and K5M images suggests that the two instruments cannot be interchanged. Meibomian gland dropout scores did not correlate significantly with clinical signs. Using a finer scale may be beneficial for detecting change.

The relief of dry eye signs and symptoms using a combination of lubricants, lid hygiene and ocular nutraceuticals

Purpose To determine the combined effect of TheraTears® Lubricant Eye Drops, TheraTears® SteriLid Eyelid Cleanser, and TheraTears® Nutrition on dry eye signs and symptoms. Methods This prospective study enrolled 28 dry eye participants. Participants were instructed to use the Lubricant Eye Drops at least 2–4× a day, SteriLid 1–2× a day, and Nutrition 3 gel caps once a day. Participants were followed up at baseline, 1 month and 3 months. Outcome variables were the Ocular Surface Disease Index (OSDI), Symptom Assessment iN Dry Eye (SANDE) questionnaire, non-invasive tear break-up time (NIBUT), osmolarity, number of meibomian glands blocked (#MG blocked), meibum quality, eyelid margin features, Schirmers test, tear film lipid layer thickness (LLT), meniscus height, corneal and conjunctival staining. Results Twenty participants (mean age = 43, from 23 to 66, 17F, 3M) completed the study. Participants reported having used, on average, the Lubricant Eye Drop 2.4×/day, the SteriLid 1.1×/day, and the Nutrition 3 gel caps 1×/day. There was a significant change over time (p < 0.05) for OSDI (−21.2 points), SANDE (−32.4 points), NIBUT (+0.43 s), eyelid margin features (−1.1 grade), meibum quality (−1.0 grade), and #MG blocked (−4.0 glands). Conclusion By using a combination of TheraTears® Lubricant Eye Drop, SteriLid, and Nutrition, patients experience significant relief in both dry eye symptoms and signs.

Impact of lens care solutions on protein deposition on soft contact lenses

Purpose To evaluate the effect of four contemporary lens care solutions on total protein, total lysozyme, and active lysozyme extracted from three contact lens materials. Methods Adapted contact lens wearers were recruited at three sites, and all subjects were randomly assigned to daily wear of either etafilcon A, galyfilcon A, or senofilcon A for 2 weeks. Four lens care solutions (Biotrue, OPTI-FREE PureMoist, RevitaLens OcuTec, and ClearCare) were used by each subject in random order with a new pair of lenses after a washout period between solutions of at least 4 days. After 2 weeks of daily wear, contact lenses were collected for analysis. Proteins were extracted from a subset of contact lenses (n = 568) and total protein, total lysozyme, and lysozyme activity were quantified using a modified Bradford assay, an enzyme-linked immunosorbent assay, and a micrococcal assay, respectively. Results Higher levels of total protein were extracted from etafilcon A when used with Biotrue compared to other solutions (p = 0.0001). There were higher levels of total lysozyme extracted from galyfilcon A lenses when used with PureMoist than with Biotrue or ClearCare (p < 0.006). Higher total lysozyme was extracted from senofilcon A when used with RevitaLens OcuTec compared to Biotrue (p = 0.002). Lower lysozyme activity was recovered from senofilcon A lenses with RevitaLens OcuTec when compared to all other care solutions (all p < 0.004). When Biotrue, PureMoist, or RevitaLens OcuTec were used, higher total lysozyme was extracted from galyfilcon A compared to senofilcon A (p < 0.01). When RevitaLens OcuTec was used, higher levels of active lysozyme were extracted from galyfilcon A compared to senofilcon A (p = 0.02). Conclusions The ability of lens care solutions to remove protein from lenses varies depending upon the care solution composition and also the polymeric make-up of the contact lens material.

Microbial Contamination of Contact Lens Storage Cases During Daily Wear Use.

Purpose To evaluate contact lens (CL) storage case contamination when used with four different CL care solutions during daily wear of three different CL materials. Methods A parallel, prospective, bilateral, randomized clinical trial (n = 38) was conducted. Subjects were randomly assigned to use one of three CL materials (etafilcon A, senofilcon A, or galyfilcon A) on a daily wear basis. Subsequently, each subject randomly used one of four different CL care solutions (Biotrue, OPTI-FREE PureMoist, RevitaLens OcuTec, and CLEAR CARE) for 2 weeks, along with their respective storage cases. After every 2-week period, their storage cases were collected and the right and left wells of each storage case were randomized for two procedures: (1) microbial enumeration by swabbing the storage case surface and (2) evaluation of biofilm formation (multipurpose solution cases only) using a crystal violet staining assay. Results More than 80% of storage cases were contaminated when used in conjunction with the four CL care solutions, irrespective of the CL material worn. Storage cases maintained with CLEAR CARE (mean Log colony forming units (CFU)/well ± SD, 2.0 ± 1.0) revealed significantly (p < 0.001) greater levels of contamination, compared to those maintained with Biotrue (1.3 ± 0.8) and RevitaLens OcuTec (1.2 ± 0.8). Predominantly, storage cases were contaminated with Gram-positive bacteria (≥80%). There were significant differences (p = 0.013) for the levels of Gram-negative bacteria recovered from the storage cases maintained with different CL care solutions. Storage cases maintained with OPTI-FREE PureMoist (0.526 ± 0.629) showed significantly higher biofilm formation (p = 0.028) compared to those maintained with Biotrue (0.263 ± 0.197). Conclusions Levels of contamination ranged from 0 to 6.4 Log CFU/storage case well, which varied significantly (p < 0.001) between different CL care solutions, and storage case contamination was not modulated by CL materials.

Effect of Lid Debridement-Scaling in Sjögren Syndrome Dry Eye.

Purpose To evaluate the effect of lid debridement-scaling (LDS) on dry eye signs and symptoms in subjects with Sjögren syndrome (SS). Methods This prospective randomized controlled study enrolled 14 female subjects with SS. Seven subjects were randomized into the treatment group where they were selected to receive LDS; the remainder did not receive LDS and served as control subjects. Lid debridement-scaling was conducted using a stainless steel golf club spud (Hilco Wilson Ophthalmics, Plainville, MA) on both the upper and lower eyelids of both eyes. Outcome variables were assessed before LDS and again 1 month later. The outcome variables were the Ocular Surface Disease Index (OSDI), Symptom Assessment iN Dry Eye (SANDE) visual analog scores, ocular staining (SICCA OSS [Sjögren’s International Collaborative Clinical Alliance Ocular Staining Score]), fluorescein tear breakup time (FLBUT), meibomian gland score (MGS), meibomian gland yielding liquid secretions (MGYLS) score, and line of Marx’s (LOM) position. Results Thirteen subjects completed the study. Data from only the right eye were analyzed. For the control group (n = 6; mean [±SD] age, 62.3 [±11.6] years), the pre-LDS, post-LDS, and significance level (pre-LDS mean [±SD] vs. post-LDS mean [±SD]; p value) were as follows: OSDI (58.3 [±22.1] vs. 48.3 [±29.0]; p = 0.051), SANDE (77.4 [±22.1] vs. 89.6 [±32.6]; p = 0.20), SICCA OSS (7.0 [±4.5] vs. 8.2 [±3.5]; p = 0.25), MGS (1.3 [±1.5] vs. 1.0 [±0.9]; p = 0.75), MGYLS (0.3 [±0.5] vs. 0.0 [±0.0]; p = 0.50), FLBUT (2.99 [±1.54] vs. 2.85 [±1.79]; p = 0.63), and LOM (2.0 [±0.0] vs. 2.0 [±0.0]; p = n/a). For the treatment group (n = 7; mean [±SD] age, 58.0 [±8.1] years), the pre-LDS, post-LDS, and significance level were as follows: OSDI (63.2 [±13.3] vs. 46.9 [±19.4]; p = 0.04), SANDE (72.6 [±17.1] vs. 77.0 [±28.0]; p = 0.54), SICCA OSS (6.6 [±2.9] vs. 5.0 [±3.9]; p = 0.02), MGS (1.0 [±1.2] vs. 3.1 [±1.7]; p = 0.01), MGYLS (0.0 [±0.0] vs. 0.6 [±1.0]; p = 0.50), FLBUT (3.13 [±0.81] vs. 3.45 [±1.03]; p = 0.53), and LOM (0.9 [±0.9] vs. 1.0 [±1.0]; p = 1.00). Conclusions This pilot study showed that LDS improved symptoms, ocular staining, and meibomian gland function for the group that received LDS. This indicates that LDS can aid in the management of SS dry eye.

Corneal Swelling with Cosmetic etafilcon A Lenses versus No Lens Wear

Purpose To determine if the use of pigments or adding polyvinyl pyrrolidone during the fabrication of 1-DAY ACUVUE DEFINE (AD) brand contact lenses impacts open-eye corneal swelling compared with no lens wear (NLW). Methods A partial double-masked, randomized, bilateral crossover study was conducted in 24 Asian subjects using AD, 1-DAY ACUVUE DEFINE with Lacreon (ADL), NLW, and a control lens with no tint (1-DAY ACUVUE MOIST [AM]). Central corneal thickness was measured before insertion and immediately after removal after 8 ± 1 h of open-eye wear using an optical pachymeter in one eye. Corneal thickness along a 10-mm cord was measured in the contralateral eye using the Visante optical coherence tomographer (OCT). Corneal swelling was tested for noninferiority using a 5% margin. The endothelial bleb response was measured at baseline and 20 min after lens insertion using specular microscopy. Subjective grading of corneal staining and limbal/bulbar hyperemia were also monitored. Results After 8 ± 1 h of open-eye wear, central corneal swelling across the study lenses with either optical pachymeter or OCT methods was negligible. Peripheral corneal swelling least-square mean differences with OCT were −0.03% (95% confidence interval [95% CI], −0.65 to 0.58%) and −0.26% (95% CI, −0.87 to 0.36%) between AD and ADL and the control lens (AM), respectively, and 1.67% (95% CI, 1.06 to 2.29%) and 1.45% (95% CI, 0.84 to 2.06%) between AD and ADL and NLW, respectively. No endothelial blebs were observed. No clinically significant differences were distinguished between the lenses and NLW for corneal staining and limbal/bulbar hyperemia. Conclusions After 8 ± 1 h of open-eye wear, central and peripheral corneal swelling along the horizontal meridian with AD, ADL, AM, and NLW were equivalent. These results confirm that the addition of polyvinyl pyrrolidone or pigments to etafilcon A to obtain a limbal ring design have no impact on corneal swelling or limbal/bulbar hyperemia during normal open-eye wear.

An Eyelid Warming Device for the Management of Meibomian Gland Dysfunction

Purpose To determine the effectiveness of the MGDRx EyeBag in managing meibomian gland dysfunction. Methods This was a prospective, randomized, controlled, observer-masked, bilateral eye study that enrolled 29 participants. Participants were randomized into either the EyeBag group or the control group. The EyeBag group used the EyeBag 10 minutes 2x/day, and the control group remained on their own dry eye treatment regimen (if applicable). All participants were observed at baseline, 2 weeks (2wk) and 4 weeks (4wk). At 4wk, participants in the EyeBag group were asked to stop using the EyeBag. All participants were seen again at 8 weeks (8wk). Primary outcomes were the Ocular Surface Disease Index (OSDI), Current Symptoms Questionnaire (CSQ), meibomian gland score (MG score), and non-invasive tear breakup time (NIBUT). Results Twenty-five participants completed the study (mean age 38 ± 15 years, 7 male). There was a significant change in OSDI over time for the EyeBag group (mean[lower 95% CI, upper 95% CI], baseline: 39.1[31.1,47.0], 2wk: 26.8[19.7,33.9], 4wk: 26.6[16.5,36.7], 8wk: 27.7[18.4,37.0]; p = 0.01), but not in the control group (p = 0.22), but no significant difference between groups at all time points (all p > 0.27). Symptoms immediately improved after conducting the EyeBag based on at-home CSQ scores (Δ=-5.0 points, p < 0.01), but not in the control group. For both groups, there was no significant change (p-value EyeBag,p-value control) in MG score (0.21,0.17) and NIBUT (0.49,0.06) over time. Conclusions The EyeBag may relieve symptoms of dry eye, but the effect on meibomian gland function and tear stability when used for only 4 weeks was undetectable.

Self versus examiner administration of the Ocular Surface Disease Index(

Purpose To compare the difference in Ocular Surface Disease Index© (OSDI) scores when participants were given the OSDI to complete on their own (self-guided, SG), versus under the guidance of the examiner (examiner-guided, EG). Methods 100 participants enrolled in this prospective two-visit study (fifty under-45 years old, 38F/12M; and fifty 45 years-and-older, 42F/8M). Participants who scored ≥1 on the Subjective Evaluation of Symptoms of Dryness (SESoD) were included in this study. Participants completed the OSDI SG during the first visit. Participants returned the next day and repeated the OSDI, but with EG (with standardized instructions). Participants were under deception and believed that they were comparing the OSDI to the SESoD. Results The mean OSDI score of the SG and EG administration was 32.0 ± 17.3 and 33.8 ± 19.6 respectively (p > 0.05) with 95% limits of agreement between −20.6 and +24.2. The correlation between SG and EG administration was Spearmans r = 0.81, p < 0.01. The mean difference between SG and EG was not significant (p > 0.05) for both the under-45 group, and 45-and-older group. The 95% limits of agreement for the under-45 group were smaller than the 45-and-older group (under-45: [−15.5, +13.1,], 45-and-older: [−23.3, +32.2]). A significant difference was found between 8 of the 12 questions items (all p ≤ 0.01). However, the mean difference for each was <0.6 and was not considered to be clinically significant. Conclusion There was no clinically significant difference in OSDI score between SG and EG administration, however having instructions provided with EG administration affected variability of scores in the older group more than the younger group.

Impact of protein and lipid on neutralization times of hydrogen peroxide care regimens.

Purpose: To investigate the effect of protein, lipid, and lens material on the neutralization kinetics of one-step hydrogen peroxide disinfection systems. Methods: A UV-based assay was used to determine the rate of neutralization of three one-step hydrogen peroxide systems (CIBA Vision Clear Care; CIBA Vision AOSEPT; Abbott Medical Optics UltraCare). Protein (bovine serum albumin and lysozyme) and various lipids were added to the lens cases during the neutralization phase to determine whether they influenced the rate of neutralization. Finally, rates were determined when the cases contained a silicone hydrogel lens material (lotrafilcon A) or Food and Drug Administration group IV (etafilcon A) lenses. Results: Neutralization for all three systems was complete within 90 minutes. The rate of neutralization for Clear Care and AOSEPT were not significantly different from each other (P=NS). UltraCare exhibited statistically higher levels of peroxide up to the 20-minute time point (P<0.001) Protein, lipid, or lens material did not significantly affect the rate of neutralization for any regimen (P=NS). Conclusions: Tablet-based one-step disinfection systems neutralize at a slower rate than disc-based peroxide systems, but this difference is only significant during the first 20 minutes after the onset of neutralization. Neither lens deposition nor lens material plays a role in the speed of neutralization of peroxide-based systems.