Kurt Moody

Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) and opinion of contact lens performance.

Purpose. To report on the development and validation of a short form of the Contact Lens Dry Eye Questionnaire (the CLDEQ-8) to enable it to reflect status of and change in overall opinion (“opinion”) of soft contact lenses (SCLs). Methods. Item reduction for the CLDEQ was achieved by correlation with overall opinion of SCLs at follow-up visits in a sample of 38 SCL wearers at one academic clinical site. The CLDEQ-8 score (frequency plus late day intensity of dryness, discomfort, and “blurry vision”; frequency of “closing eyes to rest them” and “removing CLs to relieve discomfort”) was then tested in 379 SCL wearers in a multicenter study with analysis stratified by opinion ratings at baseline and 2 weeks postrandomization to new silicone hydrogel SCLs. The sum of CLDEQ-8 scores (maximum 37) was correlated with opinion by Spearmans rank correlation coefficient and analyzed for change in opinion by analysis of variance (ANOVA). Results. The CLDEQ-8 scores in the validation sample were highly correlated with habitual baseline opinion (−0.44, p < 0.0001) and responsive to change in opinion postrandomization (−0.58, p < 0.0001). Baseline CLDEQ-8 scores by opinion status were as follows: Fair: 17.4 ± 8.7, Good 13.7 ± 6.4, Very Good 9.1 ± 4.7, and Excellent 6.4 ± 3.7 (ANOVA, F = 291.1, p < 0.0001). After 2 weeks, change in CLDEQ-8 scores by improvement status was as follows: Much Improved: −16.7 ± 10.0, Unchanged: −2.3 ± 5.0, to Much Worse +8.5 ± 5.8 (ANOVA, F = 16.5, p < 0.001). Conclusions. The CLDEQ-8 score significantly reflected baseline status and change in overall opinion after refitting with two types of silicone hydrogels. The CLDEQ-8 score is a valid outcome measure in SCL clinical trials to reflect opinion of SCLs.

Contact lenses in pediatrics study in Singapore.

Purpose: Previous studies in the United States have evaluated the benefits of soft contact lenses (CLs) in 8- to 12-year-old children and 13- to 17-year-old teens. This study was undertaken in Singapore and evaluated the safety, efficacy, and physiologic performance of daily disposable soft lenses in a population of children. Methods: In this open-label, bilateral, 3-month dispensing study, 59 children (8–11 years) were fit with etafilcon A spherical or toric daily disposable lenses (1-DAY ACUVUE or 1-DAY ACUVUE for ASTIGMATISM, Vistakon, Jacksonville, FL). All subjects were neophytes requiring visual correction in both eyes. The refractive inclusion criteria were plano to −9.00 diopter (D) with astigmatism of ≤2.00DC in both eyes, or hyperopia of +0.50 to +6.00D with astigmatism of 0.75D or less. The subjects underwent follow-up evaluations, which included a questionnaire for parents and subjects, at 1 week, 1 month, and 3 months. Results: Of the 59 subjects enrolled, 53 (90%) completed the study successfully. Six subjects were discontinued because of lens handling difficulties (four), unacceptable lens fit (one), and an adverse event (one). Adverse events were reported in three subjects, including the discontinuation, and in each case were due to a chalazion. Overall vision quality, overall comfort, and end-of-day comfort were graded significantly better at each of the follow-up visits compared with baseline with spectacles (P≤0.0001). Both handling and reported symptoms improved during the course of the study. The questionnaire results indicated that most of both parents and subjects preferred CLs to spectacles across a wide variety of aspects including vision, comfort, handling, and appearance. Significantly, more limbal and bulbar hyperemia was noted at follow-up visits than at baseline (P=0.0001); however, no instances of hyperemia greater than grade 2 were noted at any visit. Significantly, more corneal staining was also noted at the 1- and 3-month follow-up visits than at baseline (21% at 3 months). Conclusion: A high proportion of Singaporean children requiring vision correction are able to successfully wear daily disposable soft CLs over a 3-month period. Overall, slit lamp findings showed the prevalence of corneal staining in this study to be 21% at 3 months, which is lower than that previously reported in adults, but higher than that reported in the US Contact Lenses in Pediatrics study (6%).

Ocular physiology and comfort in neophyte subjects fitted with daily disposable silicone hydrogel contact lenses

PURPOSE To evaluate the performance of a silicone hydrogel daily disposable lens in neophyte subjects over 12 months. METHODS Seventy four subjects with no previous contact lens experience were randomised to wear narafilcon A (1 DAY ACUVUE(®) TruEye™) lenses (LW group) or to wear no contact lenses (NLW group) for 12 months. Biomicroscopy (performed by a masked investigator), visual acuity and subjective response scores were recorded at an initial visit and six follow-up visits, in addition to lens fit and surface evaluation for the LW group. Comfort was recorded with SMS messaging. RESULTS Fifteen of the LW group discontinued before the end of the study, compared with six of the NLW group. Measured visual acuity was about half a line better for the NLW group as these subjects were provided with their full sphero-cylindrical over-refraction, compared to the LW group in their best spherical corrected contact lenses; subjective scores for vision were similar for the two groups. Bulbar conjunctival hyperaemia, limbal hyperaemia, corneal staining, conjunctival staining and papillary conjunctivitis were clinically equivalent for the two groups whereas conjunctival staining was higher in the LW group. Comfort scores assessed by SMS were equivalent for the LW and NLW groups; there was a measurable improvement in comfort during the first month of wear for the LW group. CONCLUSION This work has demonstrated that modern soft lenses (narafilcon A daily disposable silicone hydrogel lenses) offer an excellent, comfortable form of vision correction, and are able to exhibit minimal alterations to ocular physiology.

Fluctuation in visual acuity during soft toric contact lens wear.

Purpose. To quantify changes in visual acuity (VA) with soft toric contact lenses as a result of lens movement and/or rotational instability caused by versional eye movements. Methods. A novel chart for vision assessment at near (40 cm) for soft toric contact lenses (VANT chart),consisting of a central, color-coded logMAR panel and eight peripheral letter targets set on a white background measuring 60 × 40 cm was constructed. In the developmental phase of the work, 10 subjects (20 eyes) wore 2 toric lenses in random order, and the impact of rapid and delayed eye versions in 8 directions of gaze on VANT acuity was investigated. In phase 2, 35 subjects (68 eyes) wore 4 toric lenses in random order, and a streamlined clinical protocol using the VANT chart was implemented. Standard assessments of toric lens fit and distance VA were also performed. Results. Testing in the first phase showed no difference for change in VA for rapid vs. delayed version movements, (p = 0.17) but acuity reduction was greater for diagonal compared with horizontal/vertical versions (p = 0.06). As such, testing in phase 2 proceeded using rapid, diagonal versions only. In this second phase, there were differences for low-contrast distance VA measures between lens types (p = 0.02) and for both VANT baseline acuity (p = 0.03) and postversion acuity (p = 0.04), but no differences were found between lenses for magnitude of vision loss (p = 0.91), which was about one line. No relationship was established between the magnitude of vision loss and measured rotational stability (p = 0.75). Conclusions. This work has demonstrated that conventional approaches to measuring VA do not fully replicate the “real world” experience of soft toric lens wearers. The VANT chart has shown that VA is reduced immediately after versional eye movements and suggests that more dynamic methods of assessing visual performance should be considered for soft toric contact lens wearers, especially given the apparent inability of lens stability measurements to predict visual performance.

The Effects of Age, Refractive Status, and Luminance on Pupil Size.

Purpose Pupil size is critical for optimal performance of presbyopic contact lenses. Although the effect of luminance is well known, little information is available regarding other contributing factors such as aging and refractive status. Methods The cohort population comprised 304 patients (127 male, 177 female) aged 18 to 78 years. Pupils were photographed at three controlled luminance levels 250, 50, and 2.5 cd/m2 using an infra-red macro video camera. Measurements of pupil diameter were conducted after transforming pixel values to linear values in millimeters. Results Luminance was the most influential factor with pupil diameter increasing with decreased luminance (p < 0.001, all comparisons). Age was also found to be a significant factor with a smaller diameter in the older groups, but overall the difference was only significant between the pre-presbyopes and the established presbyopes (p = 0.017). Pupil diameter decreased significantly with increasing age, the effect being most marked at low luminance (<0.001). The smallest pupil diameters were measured for hyperopes and the largest for myopes and although refractive error was not a significant factor alone, there was a significant interaction between luminance and refractive error with the greatest differences in pupil diameter between myopes and emmetropes at low luminance (p < 0.001). Pupil diameter changes modeled by multilinear regression (p < 0.001) identified age, luminance, best sphere refraction, and refractive error as significant factors accounting for just over 70% of the average variation in pupil diameter. Conclusions Both age and refractive status were found to affect pupil size with larger pupils measured for younger patients and myopes. Designs for multifocal contact lens corrections should take both age and refractive status into consideration; a faster progression from distance to near corrections across the optical zone of the lens is expected to be required for established presbyopes and hyperopes than it is for early presbyopes, myopes, and emmetropes.

Short-term corneal endothelial response to wear of silicone-hydrogel contact lenses in East Asian eyes

Objective. To evaluate corneal endothelial bleb response to wear of silicone-hydrogel contact lenses in eyes of East Asian subjects. Methods. A total of 24 subjects of East Asian origin, attended 3 separate sessions for a prospective, single-centre, trial. The following contact lenses were used: ACUVUE Advance with HYDRACLEAR (Advance, −3 dioptres), ACUVUE Oasys with HYDRACLEAR Plus (Oasys, −3 dioptres), Focus Night & Day (Night & Day, −3 dioptres) and SofLens 38 (+3 dioptres). A modified Balaam’s crossover design was used to randomize presentation of sessions and contact lenses within sessions. Session 1 was a comparison between Oasys and SofLens 38 under closed eye conditions, session 2 was a comparison between Advance and Night & Day under open eye conditions, and session 3 was a comparison between Oasys and Night & Day worn under closed eye conditions. Corneal endothelial images were captured with the Topcon SP-3000P noncontact Specular Microscope before lens wear, after 20 mins of wear with lenses on and 5 and 10 mins later after lens removal. Blebs were manually identified on these digital images by a masked observer. The area of blebs and total area under consideration were derived using ImageNet software and used to calculate percentage area of blebs. A boundary of equivalence of 1% was used as a clinically significant bleb area difference, and two-sided 95% confidence intervals were utilized to evaluate differences between lenses within each session. Results. In session 1, SofLens 38 produced a mean percentage area of blebs of 8.0% under closed eye conditions, which was significantly different to that produced by Oasys (1.6%). In session 2, both Advance and Night & Day produced a mean percentage bleb area of 0.4% under open eye conditions. In session 3, Oasys and Night & Day produced statistically similar mean percentage bleb areas of 1.7% and 2.0%, respectively. Conclusions. The similarity of bleb responses induced by the silicone-hydrogel lenses under the tested wearing conditions is consistent with the proposition that increases in Dk/t above a certain level will produce minimal change in corneal physiologic conditions compared with that when no lens is worn.

Visual performance with a daily disposable contact lens compared to best corrected sphero-cylindrical spectacle refraction

Paper Number: 1 Presentation time: 13:30-13:38 Visual performance with a daily disposable contact lens compared to best corrected sphero-cylindrical spectacle refraction Chantal Coles-Brennan, Kim Hoyt, Kurt Moody Purpose: Standard visual acuity (VA) measures only test visual sensitivity at high spatial frequencies, usually under high luminance conditions. A more complete insight to visual experience may be obtained by measuring contrast sensitivity (CS). This study compared electronic LogMAR (eLogMAR) VA and CS in myopes wearing a daily disposable (DD) contact lens (CL) and wearing best corrected sphero-cylindrical spectacle refraction (SCR). Method: This was a bilateral, nondispensing, 3-visit, randomizedcontrolled, crossover, single-masked, single-site study to assess visual performance in subjects fit with: (i) a senofilcon A DD CL, and (ii) SCR in trial frame. Subjects were habitual CL wearers (not wearing senofilcon A DD) aged 18-35 years, with spherical refraction -1.00D to 9.00D, cylinder ≤-0.75D and best corrected VA 6/7.5 or better in each eye. eLogMAR VA under high luminance, low contrast (HLLC) and low luminance, high contrast (LLHC) conditions was measured (Precision Vision). Contrast sensitivity function (qCSF) was measured using the AST Sentio Platform (Adaptive Sensory Technology). The area under log of CSF (AULCSF) was calculated. Results: All 43 subjects fit with CLs completed the study (mean age 26.8 years, SD4.65). LLHC monocular eLogMAR VA with CL vs SCR was 0.02 ± 0.01 vs 0.05 ± 0.01 (least square mean ± SE, p<0.05). HLLC monocular eLogMAR VA was 0.15 ± 0.02 vs 0.21 ± 0.02 (p<0.05). Percent change in contrast threshold value CL vs SCR was -11.4% at 6.0cpd, -17.8% at 12.0cpd and -17.2cpd at 18.0cpd. AULCSF with CL vs SCR was 1.37 vs 1.32 least mean square (p<0.05). Conclusions: The senofilcon A CL showed statistically significantly better eLogMAR VA than best SCR under both high luminance, low contrast and low luminance, high contrast conditions. CS testing confirmed the visual performance gains indicated by the acuity test with the CL also demonstrating a statistically significantly greater AULCSF than best SCR. Research funding received: This work was derived from an internal Johnson & Johnson Vision Care contact lens clinical trial. No other research funds were granted.

Anomalies in the Prescribing of Soft Contact Lens Power

Objectives: To determine the proportion of prescribed soft lenses rounded to the nearest half diopter and any variations from country to country and between lens types. Methods: Marketing data were obtained for soft lenses supplied during a 1-year period for lenses representing each of the following categories: mid-water hydrogel (MWH), silicone hydrogel, daily disposable, and toric silicone hydrogel (TSH). The data were analyzed for several countries/regions. Spherical lenses were analyzed in the range 1.00 to 5.75 D for plus and minus powers, and toric lenses in the range 0.50 to 5.75 D. This ensured a similar number of lenses in full or half diopter powers were compared with quarter and three-quarter diopter powers, and that there was no enforced rounding due to nonavailability of powers. By comparing the proportion of lenses from the 2 power groups, the proportion of lenses rounded to the nearest half diopter was estimated. It was assumed that half the difference between the totals of the 2 power groups represented those lenses dispensed to the nearest half diopter and, therefore, dispensed inaccurately; this was termed the “rounding rate” (RR). Results: The power distribution curve for the sphere powers spiked in half diopter steps, illustrated a bias toward prescribing full and half diopter powers. With all lenses, the RR varied widely between countries. For the MWH, this ranged from 1.7% (Canada) to 11.6% (Iberia). The RRs were 2 to 3 times higher for plus than minus power lenses, however, this also varied by country. Overall, the RRs were lower for the silicone hydrogel and daily disposable contact lenses compared with the MWH, in particular for France and Iberia. The TSH results showed the greatest consistency between countries, with RRs ranging from 3.9% (Germany) to 9.5% (Rest of Europe). Most countries showed similar or lower RRs for TSH compared with MWH although, for some countries (e.g., United Kingdom, Nordic), these were higher. There was less difference in RRs for TSH lenses between plus and minus spheres. Conclusion: A surprising proportion of soft lenses are prescribed to the nearest half diopter, although this varies according to lens type. There are also considerable variations between countries, presumably due to differences in training, fitting practices, and supply routes. These findings suggest that there is widespread room for improvement in the prescribing accuracy of soft contact lenses.