Purpose:To measure high contrast visual acuity (HCVA) when presbyopic soft contact lens (CL) wearers, requiring a spectacle addition from +0.75 to +1.75 dioptres were fit bilaterally with delefilcon A daily disposable multifocal (DT1 MF) CLs and senofilcon A daily disposable multifocal (AOM MF) CLs. Methods:In this prospective, randomized, double-masked, cross-over, non-inferiority study, presbyopic CL wearers wore two types of multifocal CLs for 1 hour each. HCVA was measured monocularly and binocularly at 6m, 66cm and 40cm under photopic and mesopic conditions. Participants rated subjective visual clarity (0-100 scale, 100=very clear) after each HCVA assessment. Pupil size was assessed under photopic and mesopic conditions. Results:Twenty-eight participants (48.6 ± 5.3 years) completed the study. DT1 MF was non-inferior to AOM MF in HCVA at 6m, 66cm and 40cm in photopic and mesopic conditions for the dominant and non-dominant eye, and binocularly. There were no statistically significant differences between lenses for subjective visual clarity ratings for any of the viewing distances, whether evaluated for photopic or mesopic conditions for the dominant or non-dominant eye or binocularly. Mean pupil size in the dominant eye was 3.6 ± 0.5mm (2.6 to 4.5mm) and 5.1 ± 0.8mm (2.8 to 6.1mm) in photopic and mesopic conditions respectively. HCVA under photopic or mesopic illumination at 6m, 66cm or 40cm was not associated with pupil size (Pearson correlation, all p>0.05). Conclusion:Both lenses provided good vision across a variety of distances at high and low illumination. DT1 MF was non-inferior to AOM MF in HCVA under photopic and mesopic illumination at distance, intermediate and near. HCVA at all distances with both study lenses was independent of pupil size. Despite their different design, both study lenses performed equally well and provide a suitable vision correction for presbyopic CL wearers, irrespective of pupil size.

Purpose:To assess the performance of delefilcon A daily disposable contact lenses (CL) in lens wearers who reported heavy digital device use. Patients and Methods:This prospective study involved lens wearers who used digital devices ≥8 hours per day. Delefilcon A CL were dispensed for 2-weeks, to be worn ≥5 days/week, ≥13 hours/day, using digital devices as normal. At-home questionnaires rating comfort, dryness, and clarity of vision (0-100 scale, 100=best) were completed on Days 1, 7, and 14±1 upon insertion, after 8 hours of device use, and before removal. At the Day 14 visit, participants rated overall comfort, dryness, and vision (0-100 scale) and completed a 5-point Likert-type scale questionnaire. Results:Thirty-five participants were eligible, 32 completed (27 females; age: 25.3±6.3 years). Median at-home ratings for comfort, dryness, and vision were ≥85, with no difference between days (all p≥0.09). Ratings decreased throughout the day (p≤0.005), except comfort (Day 7) and vision (Days 1 and 7), where ratings before removal were similar to 8 hours of device use (p≥0.014). After 2-weeks, median (range) overall ratings for comfort, dryness, and vision were 96 (70-100), 93 (50-100), and 95 (75-100), respectively. Most agreed the CL performed well, providing good comfort (91%) and vision all-day-long (94%), and did not have dryness with device use (69%). When devices were used ≥8 hours, most felt the CL performed well (84%), were satisfied with comfort (88%) and vision (88%), did not experience eye strain (81%), eye fatigue (66%), or episodes of blurred vision (75%). Conclusion:Delefilcon A lenses provided high satisfaction levels among lens wearers who spent a significant portion of their day using digital devices. Participants rated the CL highly for comfort and vision throughout the day, with most reporting no issues with dryness, eye strain, or blurred vision while wearing lenses and using digital devices.

Purpose:This study investigated the efficacy of automated ocular thermography metrics for the screening of dry eye disease (DED). Methods:This was a prospective study that enrolled 20 participants with DED, sex- and age-matched to 20 non-DED controls. Ocular Surface Disease Index (OSDI), Dry Eye Questionnaire-5 (DEQ5), noninvasive tear-break-up time (NITBUT), tear meniscus height (TMH), meibomian gland dysfunction (MGD) score, and corneal staining were measured in a screening visit. The DED group was defined as: OSDI score of ≥13 or DEQ-5 score of ≥6, and DED signs in at least one eye (corneal/conjunctival/lid margin staining, NITBUT <5 seconds, tear film osmolarity ≥308 miliosmoles [mOsm]/L). Thermography recording of the ocular surface (natural blinking over a period of 30 seconds) was conducted the next day, and the thermal cooling rate and thermal interblink interval (IBI) were derived. Results:Thermal IBI was significantly shorter in the DED group compared to the non-DED group (P = 0.034). The thermal cooling rate was significantly faster in the DED group (P = 0.047). Thermal IBI significantly correlated with DEQ5 (r = -0.37, P = 0.025) and OSDI (r = -0.37, P = 0.026). The thermal cooling rate significantly correlated with DEQ5 (r = -0.39, P = 0.022) and OSDI (r = -0.36, P = 0.036). The best discrimination was achieved by combining the thermal cooling rate and TMH, with an area under the curve (AUC) = 0.80 (sensitivity = 0.87 and specificity = 0.63). Conclusions:The thermal IBI and thermal cooling rate were significant predictors of DED, suggesting the utility of ocular thermography for DED screening. Translational Relevance:Automated ocular thermography may help to assess ocular dryness in a noninvasive, quantifiable, and real-time manner.

Purpose:To evaluate the effectiveness of lifitegrast ophthalmic solution 5% in alleviating end-of-day dryness and discomfort in symptomatic contact lens (CL) wearers. Patients and Methods:This was an open-label study in symptomatic CL wearers with ratings of ≥40 for end-of-day dryness on a visual analog scale (VAS; 0-100 scale; 100 worst). Participants wore their habitual CLs and instilled lifitegrast twice daily for 12 weeks with lenses removed. The performance of lifitegrast was assessed by comparing VAS 0-100 ratings (100=worst) at 2, 6 and 12 weeks for end-of-day dryness and discomfort and Contact Lens Dry Eye Questionnaire-8 (CEQ-8) scores to baseline levels. Tear samples were collected at all visits to measure 10 different tear cytokines. Results:Forty participants (33F, mean age 30.8±12.1 years, 65% daily disposable CL users) completed the study. There were no serious adverse events. Median (range) visual analog scale ratings for end-of-day dryness (Baseline: 76 (19-99); 2-weeks: 43 (0-95); 6-weeks: 26 (0-94); 12-weeks: 15 (0-98)) and discomfort (Baseline: 70 (10-97); 2-weeks: 45 (0-95); 6-weeks: 25 (0-84); 12-weeks 11 (0-96)) both significantly improved over time (all p<0.01). At baseline, 100% of participants rated dryness ≥40, which dropped to 17% at 12 weeks. Baseline CLDEQ-8 scores of 22 (12-31) had significantly decreased to 11 (1-26) at 12 weeks. Comfortable CL wear time increased significantly from 6±2 hours at baseline to 9±3 hours at 6 and 12 weeks (all p<0.01). Cytokine levels did not change over time. Conclusion:Lifitegrast significantly improved end-of-day dryness, end-of-day discomfort, CLDEQ-8 scores and comfortable CL wear time within 2 weeks of use.

This investigation examined the image and vision quality of two commercially available daily disposable myopia control soft contact lenses. Wavefront errors were measured with an SHS Ophthalmic aberrometer for two myopia control soft contact lenses: a coaxially designed dual-focus lens (omafilcon A, CooperVision MiSight® 1 day, MS1d) and a design employing multiple add powers that included non-coaxial optics in annular add zones (senofilcon A, Johnson Johnson Vision ACUVUE® Abiliti™ 1-Day, AB). Geometric optics ray tracing generated point-spread functions and wave optics were used to compare modulation transfer functions (MTFs) and simulated letter images. Twenty-six myopic children completed a randomised, non-dispensing, contralateral double-masked clinical trial. After 1 h of wear, right and left eye visual acuity (VA), subjective vision quality and lens preference (Likert) were assessed while viewing monocularly. The lens containing non-coaxial optics employed a small central zone with approximately +10.00 D of added power and two annular rings with a power gradient typical of non-coaxial optics. The coaxial design contained a centre zone with a distance correction and two annular zones with a fixed add power of approximately +2.00 D. MTFs and simulated images were better with small pupils, which was most noticeable with the coaxial design. Distance VA was -0.02 ± 0.04 with MS1d and 0.09 ± 0.08 with AB, p < 0.01. The majority of participants (77

Purpose: To assess the benefits of scleral lenses (SLs) with and without Hydra-PEG in non-lens wearers with dry eye symptoms.

It is important to be able to measure the range of clear focus in clinical practice to advise on presbyopia correction techniques and to optimise the correction power. Both subjective and objective techniques are necessary: subjective techniques (such as patient reported outcome questionnaires and defocus curves) assess the impact of presbyopia on a patient and how the combination of residual objective accommodation and their natural DoF work for them; objective techniques (such as autorefraction, corneal topography and lens imaging) allow the clinician to understand how well a technique is working optically and whether it is the right choice or how adjustments can be made to optimise performance. Techniques to assess visual performance and adverse effects must be carefully conducted to gain a reliable end-point, considering the target size, contrast and illumination. Objective techniques are generally more reliable, can help to explain unexpected subjective results and imaging can be a powerful communication tool with patients. A clear diagnosis, excluding factors such as binocular vision issues or digital eye strain that can also cause similar symptoms, is critical for the patient to understand and adapt to presbyopia. Some corrective options are more permanent, such as implanted inlays / intraocular lenses or laser refractive surgery, so the optics can be trialled with contact lenses in advance (including differences between the eyes) to better communicate with the patient how the optics will work for them so they can make an informed choice.

Purpose: To evaluate the impact on the lag of accommodation (LOA) in emmetropic children after short-term wear of full-field Diffusion Optics Technology (TM) (DOT) spectacle lenses, designed to modulate retinal contrast to control myopia progression. Patients and Methods: This was a single-visit, prospective, randomized, subject-masked study of emmetropes (ametropes +/- 1.00D or less in each meridian) with no history of myopia control treatment. Unaided logMAR visual acuity was measured, and ocular dominance was determined using the sighting method. In a randomized order, participants wore plano full-field contrast management (DOT) spectacles (no clear central aperture) or control spectacles (standard single vision spectacle lenses). Each participant was given 5 minutes for adaptation to the respective lenses before open field autorefraction measurements were taken at 6 meters and 40 cm. Ten measurements were taken for each eye. Data were evaluated from the right eye and the dominant eye separately. Results: A total of 30 participants (20 females and 10 males) with a mean age of 10.4 +/- 2.8 (7 to 17) years completed the study. There was no significant difference in right eye mean LOA with contrast management spectacles 0.57 +/- 0.39D versus control spectacles 0.62 +/- 0.34D; Wilcoxon test, p = 0.37. For dominant eyes, LOA values were 0.60 +/- 0.40D and 0.68 +/- 0.33D with contrast management spectacles and control spectacles, respectively (p = 0.14). Additionally, no significant difference was observed in mean LOA between males and females or between age groups (7- 11 years vs 12- 17 years) for either right or dominant eyes with contrast management or control spectacles (all p > 0.05). Conclusion: Full-field contrast management spectacle lenses had no significant effect on LOA compared to standard single vision spectacle lenses, indicating no differential impact on accommodative response over the short period of lens wear tested.

Purpose:This prospective comparative study aimed to assess the effects on contact lens comfort, dryness, and wear time when symptomatic daily disposable (DD) contact lens (CL) wearers were refit with delefilcon A (DT1) lenses. Patients and Methods:Thirty five symptomatic DD CL wearers with dry eye disease as determined according to the TFOS DEWS 2 guidelines, were enrolled and completed the study. Participants wore their habitual DD CLs during an initial assessment and were subsequently refit with DT1 for 1 month. Participants were masked to the study lens type. Subjective ratings of end-of-day comfort and dryness, average wear time, and comfortable wear time were evaluated as primary endpoints. Results:Of the 35 participants, two participants were classified as aqueous deficient dry eye, while the remaining participants exhibited symptoms primarily due to evaporative causes. The median CLDEQ-8 score for dryness significantly improved from 17 (fair) with habitual lenses to 13 (good) with DT1 lenses (p < 0.01). Participants reported significantly better end-of-day comfort (p = 0.01) and less end-of-day dryness (p = 0.01) with DT1 compared to their habitual DD lenses. The comfortable wear time was significantly longer with DT1 (8.5 ± 4.1 hours) compared to habitual DD lenses (6.7 ± 3.2 hours) (p = 0.04). No significant differences were observed in vision ratings (p = 0.07). Conclusion:Refitting symptomatic DD CL wearers with DT1 resulted in improved end-of-day comfort, reduced end-of-day dryness, and extended comfortable wear time compared to their habitual lenses. These findings suggest that DT1 may offer benefits for symptomatic DD wearers with dry eye disease.

Purpose:To determine the minimal clinically important difference (MCID) for contact lens (CL)-related subjective responses and explore whether MCID values differ between subjective responses and study designs. Methods:This was a retrospective analysis of data from seven one-week bilateral crossover studies and 14 one-day contralateral CL studies. For comfort, dryness, vision, or ease of insertion, participants rated on a 0-100 visual analogue scale (VAS) and indicated lens preference on a five-point Likert scale featuring strong, slight, and no preferences. For each criterion, four MCID estimates were calculated and averaged: mean VAS score difference for "slight preference," lower limit of 95% confidence interval VAS score difference for "slight preference," difference in mean VAS score difference between "slight" and "no preference" and 0.5 standard deviation of VAS scores. Results:The four calculation methods generated a small range of MCID values. For bilateral studies, the averaged MCID was 7.2 (range 5.4-8.8) for comfort, 8.1 (5.2-10.6) for dryness, 7.1 (5.5-9.3) for vision and 7.6 (6.0-10.5) for ease of insertion. For contralateral studies, the averaged MCID was 6.9 (6.1-7.6) for comfort at insertion and 7.5 (6.8-8.2) for end-of-day comfort. Conclusions:This work demonstrated very similar MCID values across subjective responses and study designs, in a population of habitual soft CL wearers. In all cases, MCID values were on average seven units on a 0 to 100 VAS. Translational Relevance:This work provides MCID values which are important for interpreting ocular subjective responses and planning clinical studies.

Aims To evaluate the myopia control efficacy of Diffusion Optics Technology (DOT) spectacle lenses in children over a 4-year treatment period.Methods CYPRESS Part 1 (NCT03623074) was a 3-year multicentre, randomised, controlled, double-masked trial comparing two investigational spectacle lens DOT designs (Test 1, Test 2) and standard single vision Control lenses in 256 North American children aged 6–10 years. Children completing Part 1 (n=200) were invited to enrol in CYPRESS Part 2 (NCT04947735) for an additional 1-year period. In Part 2, Test 1 (n=35) and Control groups (n=42) continued with their original lens assignment and the Test 2 group (n=21) were crossed over to Test 1 (DOT 0.2) lenses. The co-primary endpoints were change from baseline in axial length (AL) and cycloplegic spherical equivalent refraction (cSER).Results Test 1 spectacle lenses demonstrated superiority to the Control in both co-primary endpoints: with a difference between means (Test 1−Control) of −0.13 mm for AL (p=0.018) and 0.33 D for cSER (p=0.008) in Part 1 and −0.05 mm for AL (p=0.038) and 0.13 D for cSER (p=0.043) in Part 2. Comparing treatment effects in Part 1 and 2 suggests that COVID-19 public health restrictions negatively impacted treatment efficacy in study years 2 and 3.Conclusion DOT 0.2 spectacle lenses are safe and effective at reducing myopia progression, with additional benefit evident in year 4 of wear. These results support the hypothesis that a mild reduction in retinal contrast can slow myopia progression in young children. The unprecedented disruption in participant schooling and lifestyle during the COVID-19 pandemic may have depressed treatment efficacy in Part 1.

Purpose: To explore links between subjective comfort and vision in habitual multifocal soft contact lens (MFCL) wearers when refit with daily disposable MFCLs, to determine which factors are relevant for success with MFCLs and evaluate consistency between MFCLs of different designs. Patients and Methods: This work examined subjective measures in a randomised, participant masked, bilateral wear crossover study at five optometry practices. Fifty-eight habitual MFCL wearers wore stenfilcon A multifocal (stenA-MF; CooperVision Inc) and delefilcon A multifocal (delA-MF; Alcon) for two-weeks. Subjective ratings included satisfaction with comfort and vision and agreement questions. Results: Agreement with "I would like to wear this MFCL in the future" was taken to indicate success with each MFCL; agreement was significantly higher with stenA-MF. There was strong correlation between agreement responses for "I would like to wear this MFCL in the future" and "MFCL met my needs for vision" with both lenses (p<0.01). However, it was only with stenA-MF, which had higher agreement responses to both statements (p<0.05), that responses to these two statements correlated with satisfaction with end-of-day (EOD) comfort (p<0.01). These differences in correlations between the two lenses are seemingly driven by greater satisfaction with stenA-MF for near and intermediate vision (p<0.05). Conclusion: Subjective vision and comfort were only correlated when vision met the needs of most participants. Meeting participants' needs for vision correlated strongly with wanting to wear a MFCL. Results indicate that meeting vision needs is more important than meeting comfort needs when influencing whether presbyopic patients continue wearing MFCLs.

Purpose The purpose of this study was to evaluate the performance of verofilcon A daily disposable contact lenses (CL) in CL wearers who identified themselves as heavy digital device users. Patients and Methods This prospective, non-masked, open-label study enrolled CL wearers who reported ≥6 hours digital device use per day. Participants were dispensed with the verofilcon A study lenses for 14±2 days, to be worn for at least 5 days a week and 10 hours per day, while continuing their normal routine of digital device use. Participants rated the lens performance at the Day 14 visit using a 0–100 (with 100 being best) scale. Ratings were completed at lens insertion, after 6 hours of digital device use, just before CL removal and for overall experience. Participants also completed a 4-point (strongly agree/disagree, slightly agree/disagree) Likert scale-based questionnaire. Results Thirty-two participants were eligible and completed the study (27 females; age 25.8 ± 6.0 years, ranging from 19 to 40). Overall lens performance ratings at the Day 14 visit (mean ± standard deviation) for comfort, dryness, and clarity of vision were 91 ± 11, 88 ± 11, and 92 ± 9, respectively. Subjective ratings were stable throughout the day with no significant differences after insertion, after 6 hours of digital device use and before CL removal (all p>0.05). The majority of participants agreed that the study lenses performed well, provided good all-day comfort (28/32; p<0.01) and good all-day vision (29/32; p<0.01). Participants also agreed that after ≥6 hours of digital device use they were satisfied with CL comfort (27/32; p<0.01), vision (29/32; p<0.01) and that the lenses provided good performance (26/32; p<0.01). Conclusion Verofilcon A lenses were found to perform well, with high ratings for comfort, dryness and vision that remained high throughout the day, during extensive digital device use.

Purpose: To evaluate subjective comfort and vision with two daily disposable multifocal contact lenses (MFCLs) in habitual MFCL wearers.

Purpose: Practitioners can be reluctant to switch successful multifocal soft contact lens (MF) wearers to different materials or replacement frequencies, fearing the new MF will be less accepted. Subjective responses are highly valued in MF fitting and this study investigated subjective responses from habitual MF (hab-MF) wearers after a refit into daily disposable MF; stenfilcon A (stenA-MF) and delefilcon A (delA-MF).