Comparative Analysis of Tear Proteins in Keratoconic Scleral Lens Wearers with Variation in Limbal Clearance.

SIGNIFICANCE: Cytokine and protease analysis revealed relative changes in the post-lens tear film of scleral lenses with low and high limbal clearances. Results from this study indicate that midperipheral lens fit is an important fitting feature that can impact the inflammatory response of a keratoconic eye. PURPOSE: The purpose of this study was to investigate changes in levels of inflammatory mediators in the post-lens tear film of keratoconic scleral lens wearers with varying limbal clearance designs. METHODS: Twenty-two keratoconic eyes were fitted with two sets of scleral lenses that were consistent in lens diameter and central sagittal depth but varied in limbal clearance by approximately 50 µm. Lenses were worn in a randomly assigned order for a 2-week period each. At each follow-up visit, immediately after lens removal, tear samples were collected with a microcapillary tube (10 µL, 0.5 mm in diameter) from the bowl of the inverted scleral lens. Tear cytokine and protease analysis was performed using a multiplex electrochemiluminescent array (Meso Scale Discovery, Rockville, MD) instrument. Levels of interleukins 1, 6, and 8; tumor necrosis factor α; and matrix metalloproteinases 1 and 9 were compared and analyzed. RESULTS: Levels of interleukin 1ß, tumor necrosis factor α, and matrix metalloproteinase 1 increased with high limbal clearance (P = .01, .006, and .02, respectively). No change in interleukins 6 and 8 levels was found (P > .05). A decrease in matrix metalloproteinase 9 was noted in post-lens tear film of scleral lenses with high limbal clearance (P = .10). DISCUSSION: Relative changes in the cytokine and protease levels were found when comparing low and high limbal clearance, indicating that the midperipheral lens fit is an important feature that can impact the inflammatory response of the keratoconic eye.

Objective and Subjective Evaluation of Clinical Performance of Scleral Lens with Varying Limbal Clearance in Keratoconus.

SIGNIFICANCE: This study evaluates how limbal clearance (LC) may impact the clinical performance of scleral lenses based on subjective response on comfort and ocular responses. Limbal zone designs in scleral lenses might affect the integrity of the limbal epithelial tissue as a result of a combined hypoxic and compression-related etiology. PURPOSE: This study aimed to investigate the clinical performance and ocular and subjective responses to the wear of scleral lenses having varying LC. METHODS: Lenses with varying LC with a difference of 50 µm were fitted on and compared among keratoconic participants. The lenses were worn during a 2-week period. Visual analog scales concerning subjective comfort were completed. Ocular surface findings including hyperemia, limbal staining, and corneal swelling were compared. RESULTS: Participants reported greater comfort achieved with high LC. No difference in limbal and bulbar hyperemia was found (P > .05). Corneal response to scleral lens wear with both low and high LCs seems to result in similar perilimbal staining and negative corneal staining. An increase in corneal pachymetric values was noted at the central and peripheral cornea, with no difference between low- and high-LC lenses (all, P < .05). Quadrant-specific analysis indicated that all meridians at both 6 and 8 mm were increased for the low-LC lenses (all, P < .05) and only the temporal region for the high-LC lenses (P = .02). CONCLUSIONS: Limbal clearance may play an important role in subjective performance in scleral lenses but does not impact the degree of hyperemia in either the limbal or bulbar region. Although low LC might result in more compression-related changes to ocular surface, high LC is associated with greater comfort and greater edematous changes. Limbal zone designs in scleral lenses might affect the integrity of the limbal epithelial tissue as a result of a combined hypoxic and compression-related etiology.

Scleral Lens Clearance Assessment with Biomicroscopy and Anterior Segment Optical Coherence Tomography.

SIGNIFICANCE: It is important to be able to accurately estimate the central corneal clearance when fitting scleral contact lenses. Tools available have intrinsic biases due to the angle of viewing, and therefore an idea of the amount of error in estimation will benefit the fitter. PURPOSE: To compare the accuracy of observers' ability to estimate scleral contact lens central corneal clearance (CCC) with biomicroscopy to measurements using slit-lamp imaging and anterior segment optical coherence tomography (AS-OCT). METHODS: In a Web-based survey with images of four scleral lens fits obtained with a slit-lamp video imaging system, participants were asked to estimate the CCC. Responses were compared with known values of CCC of these images determined with an image-processing program (digital CCC) and using the AS-OCT (AS-OCT CCC). Bland-Altman plots and concordance correlation coefficients were used to assess the agreement of CCC measured by the various methods. RESULTS: Sixty-six participants were categorized for analysis based on the amount of experience with scleral lens fitting into novice, intermediate, or advanced fitters. Comparing the estimated CCC to the digital CCC, all three groups overestimated by an average of +27.3 ± 67.3 µm. The estimated CCC was highly correlated to the digital CCC (0.79, 0.92, and 0.94 for each group, respectively). Compared with the CCC measurements using AS-OCT, the three groups of participants overestimated by +103.3 µm and had high correlations (0.79, 0.93, and 0.94 for each group). DISCUSSION: Results from this study validate the ability of contact lens practitioners to observe and estimate the CCC in scleral lens fittings through the use of biomicroscopic viewing. Increasing experience with scleral lens fitting does not improve the correlation with measured CCC from digital or the AS-OCT. However, the intermediate and advanced groups display significantly less inter-observer variability compared with the novice group.

The Impact of Scleral Contact Lens Vault on Visual Acuity and Comfort.

PURPOSE: To assess how varying degrees of corneal clearance of scleral contact lenses (ScCL) impact visual acuity (VA) and comfort in patients with corneal ectasia. METHOD: Three ScCL were fitted to 20 subjects with previous diagnosis of either keratoconus (n=18) or pellucid marginal degeneration (n=2). Fitting of ScCL was based on corneal sagittal height (CSH) measured with Visante OCT at a 15-mm chord on the horizontal meridian. To select the ScCL from the diagnostic lens set, values of 325, 375, and 425 µm were randomly added in sequence to CSH. Subjects wore ScCL for 1 hr. Central corneal clearance (CCC) and topographic corneal clearance (TCC) along the vertical meridian were assessed using an ultralong optical coherence tomographer. High-contrast VA (HCVA) and low-contrast VA (LCVA) were measured using a logarithm of the minimum angle of resolution VA chart, and comfort ratings were obtained with a standard comfort scale (0-100). RESULTS: Mean CSH in the horizontal meridian was 3.78±0.53 (range: 3.33-4.17) mm at a 15-mm chord. Mean CCC was 190±100 µm (TCC: 160±94 µm at +3 mm and 180±94 µm at -3 mm), 360±120 µm (TCC: 260±100 µm at +3 mm and 330±110 µm at -3 mm), and 450±170 µm (TCC: 320±120 µm at +3 mm and 400±120 µm at -3 mm) for each lens (P=0.001). Mean HCVA for lenses 1, 2, and 3 were 0.05±0.12, 0.07±0.11, and 0.11±0.08 respectively, which were significantly different (P=0.02). Tukey post hoc analysis showed that this difference was only significant between lenses 1 and 3 (P=0.01). Similar findings were found for LCVA. Comfort ratings for lenses 1, 2, and 3 were 74.9±9.2, 79.7±11.6, and 78.6±10.8, respectively (P=0.24). CONCLUSION: The CSH is an effective method of determining the appropriate lens/cornea relationship. Lens 2 (+375 µm) gave the best combination of acuity and comfort ratings. Evaluation of the fluorescein pattern must be balanced with VA and comfort ratings for successful fitting in a clinical setting.

Multicenter Testing of a Risk Assessment Survey for Soft Contact Lens Wearers With Adverse Events: A Contact Lens Assessment in Youth Study.

PURPOSE: To test the ability of responses to the Contact Lens Assessment in Youth (CLAY) Contact Lens Risk Survey (CLRS) to differentiate behaviors among participants with serious and significant (S&S) contact lens-related corneal inflammatory events, those with other events (non-S&S), and healthy controls matched for age, gender, and soft contact lens (SCL) wear frequency. METHODS: The CLRS was self-administered electronically to SCL wearers presenting for acute clinical care at 11 clinical sites. Each participant completed the CLRS before their examination. The clinician, masked to CLRS responses, submitted a diagnosis for each participant that was used to classify the event as S&S or non-S&S. Multivariate logistic regression analyses were used to compare responses. RESULTS: Comparison of responses from 96 participants with S&S, 68 with non-S&S, and 207 controls showed that patients with S&S were more likely (always or fairly often) to report overnight wear versus patients with non-S&S (adjusted odds ratio [aOR], 5.2; 95% confidence interval [CI], 1.4-18.7) and versus controls (aOR, 5.8; CI, 2.2-15.2). Patients with S&S were more likely to purchase SCLs on the internet versus non-S&S (aOR, 4.9; CI, 1.6-15.1) and versus controls (aOR, 2.8; CI, 1.4-5.9). The use of two-week replacement lenses compared with daily disposables was significantly higher among patients with S&S than those with non-S&S (aOR, 4.3; CI, 1.5-12.0). Patients with S&S were less likely to regularly discard leftover solution compared with controls (aOR, 2.5; CI, 1.1-5.6). CONCLUSIONS: The CLRS is a clinical survey tool that can be used to identify risky behaviors and exposures directly associated with an increased risk of S&S events.

Effect of Time on Scleral Lens Settling and Change in Corneal Clearance.

SIGNIFICANCE: With the increase in the use of scleral contact lenses among practitioners, questions regarding lens settling are gradually gaining attention. This is because current studies support the notion that scleral lenses settle back over time. More research is needed to understand the exact cause and the factors that underpin such phenomenon. PURPOSE: The present study aims to assess the effect of time on topographic corneal clearance of three scleral contact lenses of varying sagittal depths. METHODS: Three scleral contact lenses were fitted to 20 subjects with previous diagnosis of keratoconus (n = 18) or pellucid marginal degeneration (n = 2). The fit was based on corneal sagittal height measured with the Visante optical coherence tomographer (OCT) at 15 mm along the horizontal meridian. To select an appropriate lens from the diagnostic lens set, values of 325 µm (lens 1), 375 µm (lens 2), and 425 µm (lens 3) were randomly added in sequence to the corneal sagittal height. Subjects wore each lens for 1 hour. Corneal clearance was measured at 10-minute intervals for 1 hour using a custom ultra-long OCT. To assess change in clearance, central point and two mid-peripheral points (+3 mm and -3 mm) along an 8-mm chord were measured by taking differences at each time point up to 1 hour. Measurements were repeated for the two other lenses. RESULTS: Mean central corneal clearance loss for all three lenses was 33.83 ± 48.40 µm. This was 26 ± 27 µm (13 ± 14 µm, +3 mm; 34 ± 37 µm, -3 mm), lens 1; 35 ± 59 µm (38 ± 61 µm, +3 mm; 52 ± 69 µm, -3 mm), lens 2; and 41 ± 54 µm (33 ± 26 µm, +3 mm; 52 ± 48 µm, -3 mm), lens 3, respectively. There was no significant difference (P = 0.06) at central and other locations for lens 1 (location and over time). There were significant differences for both lenses 2 and 3 (P < .001, P = .01, respectively) for all three locations and over time. CONCLUSIONS: There is a likelihood of clearance loss after 1 hour of lens wear. This varies between subjects, initial lens-fit relationship, and over time.

Change in over-refraction after scleral lens settling on average corneas.

PURPOSE: The purpose of this study was to determine the change in over-refraction, if any, after a scleral lens settled on the eye for 6-8 h. METHODS: Sixteen patients of varying refractive errors and normal corneal curvatures (measured with Pentacam™ Oculus) were fitted with trial Mini-Scleral Design (MSD) scleral lenses (15.8 mm diameter) in one eye. The sagittal depths of the scleral lenses were selected by adding 350 µm to the corneal sagittal heights measured at a chord length of 15 mm with the Visante™ optical coherence tomographer (OCT) anterior segment scans and picking the closest available trial lens in the set. Initial measurements were taken 30 min after lens insertion and included an auto-refraction, subjective refraction, and best sphere refraction over the contact lens. Visual acuities and Visante™ OCT anterior segment scans were also taken. These measurements were repeated after 6-8 h of lens wear. RESULTS: Over the trial wearing period, the average change in the spherical component of the over-refraction was +0.06 D (S.D. 0.17) (p = 0.16). The average change in cylinder was +0.04 D (S.D. 0.19) (p = 0.33). The average absolute change in axis was 1.06° (S.D. 12.11) (p = 0.74). The average change in best sphere was +0.13 ± 0.30 D (p = 0.12). There was no significant change in visual acuity with the best sphere over-refraction over the 6-8 h wearing period. There was a significant change in central corneal clearance over the wearing period of 83 µm (S.D. 22) (p < 0.0001). CONCLUSION: Despite a significant change in the central corneal clearance due to thinning of the fluid reservoir as the scleral lens settled (an average decrease of 83 µm after wearing the lenses for 6-8 h), there was not a statistically significant change in the subjective over-refraction (sphere, cylinder, and axis) or best sphere or visual acuity. This study has confirmed that there is no link between reduction in central corneal clearance and change in over-refraction for average corneas.

Contact Lens Wearer Demographics and Risk Behaviors for Contact Lens-Related Eye Infections--United States, 2014.

Contact lenses provide safe and effective vision correction for many Americans. However, contact lens wearers risk infection if they fail to wear, clean, disinfect, and store their contact lenses as directed. Over the past decade, CDC has investigated several multistate outbreaks of serious eye infections among contact lens wearers, including Acanthamoeba keratitis. Each investigation identified frequent contact lens hygiene-related risk behaviors among patients. To guide prevention efforts, a population-based survey was used to estimate the number of contact lens wearers aged ≥18 years in the United States. A separate online survey of contact lens wearers assessed the prevalence of contact lens hygiene-related risk behaviors. Approximately 99% of wearers reported at least one contact lens hygiene risk behavior. Nearly one third of contact lens wearers reported having experienced a previous contact lens-related red or painful eye requiring a doctor's visit. An estimated 40.9 million U.S. adults wear contact lenses, and many could be at risk for serious eye infections because of poor contact lens wear and care behaviors. These findings have informed the creation of targeted prevention messages aimed at contact lens wearers such as keeping all water away from contact lenses, discarding used disinfecting solution from the case and cleaning with fresh solution each day, and replacing their contact lens case every 3 months.

Comparison between live and photographed slit lamp grading of corneal staining.

PURPOSE: To compare live and photographic (still) grades of corneal staining of the same eyes and the repeatability of grading between two investigators. METHODS: Thirty patients were recruited to participate in a contact lens study, and their level of corneal staining was graded by two investigators in situ (live images), using slit lamp biomicroscopy. Digital still images of the corneal staining were also captured during the study visits. An independent observer selected 105 of the still images graded by investigator 1 and another 105 images graded by investigator 2 and presented them to the original investigator in a random order, on three separate occasions. Grading was performed at the time of the live grading and the three still image sessions, using the Centre for Contact Lens Research corneal staining scale that combines grades of both extent and type to provide an overall "global staining score" from 0 to 10,000 for corneal staining. A comparison was made between live and still grades as well as the intrainvestigator repeatability for the multiple grading of the still images. RESULTS: The mean (±SD) of corneal staining grades recorded for the same eyes examined live and then later on three occasions was 1795 (±1083) and 714 (±974), respectively, for participants examined by investigator 1 (p < 0.001) and 1854 (±1075) and 461 (±411) for those examined by investigator 2 (p < 0.001). There was a significant difference over the three repeated still grading sessions for each investigator (p < 0.001), although there was a high degree of consistency among the three still grading sessions for each of the investigators: the intraclass correlation for investigator 1 was 0.91 (confidence interval, 0.87 to 0.93) and that for investigator 2 was 0.82 (confidence interval, 0.77 to 0.87). DISCUSSION: Digital still image grading of corneal staining significantly underrepresented the amount of corneal staining observed through a slit lamp. Clinical investigators graded corneal staining with a high degree of consistency.

Optical edge effects create conjunctival indentation thickness artefacts.

PURPOSE: Conjunctival compression observed in ultrahigh resolution optical coherence tomography (UHR-OCT) images of contact lens edges could be actual tissue alteration, may be an optical artefact arising from the difference between the refractive indexes of the lens material and the conjunctival tissue, or could be a combination of the two. The purpose of this study is to image the artefact with contact lenses on a non-biological (non-indentable) medium and to determine the origins of the observed conjunctival compression. METHODS: Two-dimensional cross-sectional images of the edges of a selection of marketed silicone hydrogel and hydrogel lenses (refractive index ranging from 1.40 to 1.43) were acquired with a research grade UHR-OCT system. The lenses were placed on three continuous surfaces, a glass sphere (refractive index n = 1.52), a rigid contact lens (n = 1.376) and the cornea of a healthy human subject (average n = 1.376). The displacement observed was analysed using ImageJ. RESULTS: The observed optical displacement ranged between 5.39(0.06) µm with Acuvue Advance and 11.99(0.18) µm with Air Optix Night & Day when the lens was imaged on the glass reference sphere. Similarly, on a rigid contact lens displacement ranged between 5.51(0.03) and 9.72(0.12) µm. Displacement was also observed when the lenses were imaged on the human conjunctiva and ranged from 6.49(0.80) µm for the 1-day Acuvue Moist to 17.4(0.22) µm for the Pure Vision contact lens. CONCLUSIONS: An optical displacement artefact was observed when imaging a contact lens on two rigid continuous surfaces with UHR-OCT where compression or indentation of the surface could not have been a factor. Contact lenses imaged in situ also exhibited displacement at the intersection of the contact lens edge and the conjunctiva, likely a manifestation of both the artefact and compression of the conjunctiva.

Age, behavior, environment, and health factors in the soft contact lens risk survey.

PURPOSE: Previous studies have reported that the risk of corneal infectious and inflammatory events (CIEs) with soft contact lens (SCL) wear is highest in late adolescence and early adulthood. This study assesses the associations between patient age and other factors that may contribute to CIEs in young SCL wearers. METHODS: After ethics approvals and informed consent, a nonclinical population of young SCL wearers was surveyed in five US cities. Data from 542 SCL wearers aged 12-33 years were collected electronically. Responses were analyzed by age bins (12-14, 15-17, 18-21, 22-25, 26-29, and 30-33 years) using chi-square test. RESULTS: The cohort was 34% male and balanced across age bins. There were several significant associations between survey response and age (in bins). Wearers aged 18-21 years reported more recent nights with less than 6 hours of sleep (p < 0.001), more colds/flu (p = 0.049), and higher stress levels (p < 0.001). Wearers 18-21 and those 22-25 years were more likely to wear SCLs when showering (p < 0.001) and also reported more frequent naps with SCLs (p < 0.001). They reported sleeping in SCLs after alcohol use (p = 0.031), when traveling (p = 0.001), and when away from home (p = 0.024). Lower rates of regular hand washing before lens application (p = 0.054) was also associated with these groups. In addition, the relationship between reactive replacement and recommended replacement was dependent on age (p < 0.0001). CONCLUSIONS: Patient age influences lens wearing behaviors, environmental exposures, and other determinants of health that may contribute to increased CIEs in younger wearers. Targeted, age-specific education should be considered for both new and established SCL wearers.

Impact of silicone hydrogel lenses and solutions on corneal epithelial permeability.

PURPOSE: The primary purpose of this pilot study was to compare epithelial barrier function (EBF) and staining in a small group of participants using a silicone hydrogel (SH) lens worn on a daily basis with two different care regimens. Secondarily, the aim was to see if there was any correlation between corneal staining and EBF. METHODS: The corneal EBF of 10 non-lens wearers (control) and 15 age-matched asymptomatic SH contact lens wearers (test) were assessed using fluorophotometry. Biomicroscopy was performed to assess corneal staining after the EBF was measured. The lens wearers wore PureVision (FDA group V) SH lenses for two consecutive 1-month periods while using either Alcon Opti-Free Express or Renu Fresh using a randomized, investigator-masked, crossover design. Control subjects were assessed on one occasion, and lens wearers were examined before fitting with lenses and after 7, 14, and 28 days of lens wear, with each combination. RESULTS: Compared with the control group, both study groups had an increase in epithelial permeability at baseline (p ≤ 0.04). There were no changes in EBF during the treatment period for either solution (p = 0.87). A significant difference in EBF was found between the test groups during the treatment period (p = 0.02), with greater permeability in the Renu Fresh-disinfected lenses. There was poor correlation between corneal staining and EBF (r = 0.35, p > 0.05) because of large individual variations. CONCLUSIONS: Daily wear of highly oxygen-permeable SH lenses increases corneal epithelial permeability to fluorescein probably because of increased mechanical effects. In addition, certain lens-solution interactions can add to this effect, as seen in this study. Despite having a low amount of central corneal staining in the Renu Fresh group, staining and EBF did not prove to be well correlated. The presence of central corneal staining is a confounding factor when measuring EBF.

Changes in corneal thickness, corneal volume, and densitometry after long-term orthokeratology wear.

PURPOSE: To investigate changes in the corneal volume, corneal densitometry and pachymetry of young myopes wearing over-night orthokeratology (OK) contact lenses. METHODS: The medical records of 28 right eyes of young myopes wearing OK between 2013 and 2018 were reviewed retrospectively. The baseline refractive error, best corrected visual acuities at baseline and uncorrected visual acuity at the most recent visit were recorded. Corneal volume of the central 10 mm cornea; densitometry at central, nasal and temporal cornea; and pachymetry along the horizontal and vertical meridians were collected from the Pentacam® HR at baseline, after one night of lens wear, and at the latest visit. RESULTS: The mean age of subjects was 12.03 ± 3.80 years at the time of OK lens fitting and wore OK overnight for a mean duration of 666 days (range 206-1736 days). The baseline spherical equivalent refractive error was -3.03 ± 1.56 D (range -1.00 to -6.00 D). The corneal volume increased significantly after OK wear (p = 0.001). Corneal densitometry increased after OK wear, but the change did not reach statistical significance (p = 0.113). Pachymetry in the central cornea did not change significantly across all visits (p > 0.05) but increased significantly in the mid-peripheral regions of the cornea. Baseline refractive error was not found to be correlated with the changes in corneal volume, corneal densitometry, or pachymetry. CONCLUSION: The increase in corneal volume and densitometry and no significant change in the central corneal thickness may indicate the presence of corneal oedema from long-term OK wear. The baseline refraction was not correlated with the changes in corneal volume, densitometry or pachymetry.

Infrared imaging of meibomian gland structure using a novel keratograph.

PURPOSE: To examine the ability of a novel non-contact device (Keratograph 4) to image the meibomian gland (MG) structures and their morphological changes in the upper and lower eyelids. METHODS: Thirty-seven participants (mean age 57.8 ± 8.5 years; 3 males and 34 females) completed the Ocular Surface Disease Index questionnaire to assess dryness symptoms. Meibum secretion quality score, number of blocked gland orifices, and meibum expressibility scores were assessed. The lower lid (LL) and upper lid (UL) of all subjects were everted and images of the MGs were taken using the Keratograph 4 (OCULUS). A MG dropout score (MGDS) due to complete or partial gland loss of both lids was obtained using a subjective 4-grade scoring system, and digital analysis of the images using ImageJ was performed. Presence of tortuosity and visible acinar changes of the MGs were also noted. RESULTS: MGDS for both lids was significantly positively correlated with the Ocular Surface Disease Index score (r = 0.51; p < 0.05). The MGDS determined using the digital grading was also significantly positively correlated (UL: r = 0.68, p < 0.05; LL: r = 0.42, p < 0.05). The sum of the MGDS for both lids using the subjective grading scale was significantly different between the non-MGD and MGD group (1.3 ± 1.0 vs. 3.1 ± 1.1; p = 0.0004). MGDS assessment using the digital grading was significantly different between non-MGD (UL = 6%, LL = 8%) and MGD group (UL = 32%, LL = 42%; p = 0.001). Tortuous MG was observed only on the UL in 6% of the participants. Visible acinar changes were noted in 40% of the study participants. CONCLUSIONS: Infrared meibography is now possible in a clinical setting using commercially available devices, and meibography can help determine differences in MG structure in subjects symptomatic of dry eye.

Risk factors for interruption to soft contact lens wear in children and young adults.

PURPOSE: The purpose of this study was to describe age and other risk factors for ocular events that interrupt soft contact lens (SCL) wear in youth. METHODS: A retrospective chart review of SCL wearers aged 8 to 33 years at the first observed visit was conducted at six academic eye care centers in North America. Data were extracted from all visits during the observation period (>3 years). Clinical records that documented conditions resulting in an interruption of SCL wear "events" were scanned, masked for age and SCL parameters, and then adjudicated to consensus diagnosis. Generalized estimating equations were used to examine the effect of selected covariates, including age, on the risk of an event. RESULTS: Chart review of 3549 SCL wearers yielded 522 events among 426 wearers (12%). The risk of an event increased from ages 8 to 18 years, showed modest increases between ages 19 and 25 years, and then began to decline after age 25 years. New lens wearers (<1 year) were less likely to experience events (p = 0.001). Lens replacement schedule and material were also predictive of interruptions to SCL wear with the lowest risk in daily replacement and hydrogel lens wearers (both p < 0.0001). CONCLUSIONS: These results suggest that the risk of events that interrupt SCL wear peaks in late adolescence and early adulthood and reflects risk factors identified in prospective contact lens studies. Relative to older teens and young adults, patients younger than 14 years presented with significantly fewer events resulting in interrupted lens wear.

Contact lens assessment in youth: methods and baseline findings.

PURPOSE: To describe the Contact Lens Assessment in Youth (CLAY) Study design and report baseline data for a multicenter, retrospective, observational chart review of children, teenagers, and young adult soft contact lens (SCL) wearers. METHODS: Clinical charts of SCL wearers aged 8 to 33 years were reviewed at six colleges of optometry. Data were captured retrospectively for eye care visits from January 2006 through September 2009. Patient demographics, SCL parameters, wearing schedules, care systems, and biomicroscopy findings and complications that interrupted SCL wear were entered into an online database. RESULTS: Charts from 3549 patients (14,276 visits) were reviewed; 78.8% were current SCL wearers and 21.2% were new fits. Age distribution was 8 to <13 years (n = 260, 7.3%), 13 to <18 years (n = 879, 24.8%), 18 to <26 years (n = 1,274, 36.0%), and 26 to <34 years (n = 1,136, 32.0%). The sample was 63.2% females and 37.7% college students. At baseline, 85.2% wore spherical SCLs, 13.5% torics, and 0.1% multifocals. Silicone hydrogel lenses were worn by 39.3% of the cohort. Daily wear was reported by 82.1%, whereas 17.9% reported any or occasional overnight wear. Multipurpose care systems were used by 78.1%, whereas another 9.9% indicated hydrogen peroxide solutions use. CONCLUSIONS: This data represent the SCL prescribing and wearing patterns for children, teenager, and young adult SCL wearers who presented for eye care in North American academic clinics. This will provide insight into SCL utilization, change in SCL refractive correction, and risk factors for SCL-related complications by age group.

Corneal refractive therapy gas permeable lenses for the correction of hyperopia after one night of lens wear.

PURPOSE: To examine the refractive and keratometric response of corneal refractive therapy (CRT) contact lenses for hyperopia (CRT) after a single night of contact lens wear with the goal of reducing hyperopia by +3.50 D. METHOD: Twenty participants were fitted with a CRT HDS 100 contact lens, in one eye only. The back optic zone radius of the CRT lens was designed to correct 3.50 D of hyperopia. The eyes were randomly selected. The Nikon Auto Refractor was used to measure refractive error. Corneal topography and simulated K readings were measured using the Humphrey Atlas topographer. The lens was subsequently worn overnight, and the lens was assessed the next morning on awakening. RESULTS: Refractive error changed by 1.50±0.71 D (mean ± SD, range 0.50-2.75 D) immediately after lens removal in the experimental eye. Similarly, there was a change in flat K readings of 0.58±0.62 D with a range of -0.25 to +1.87 D. These results were significantly different from the baseline measurements (P<0.0001). CONCLUSIONS: The fitting of CRT HDS for hyperopia has a significant effect on corneal shape and refractive error. There was a moderate yet significant steepening of the cornea.

Impact of contact lens wear on epithelial alterations in keratoconus.

PURPOSE: The purpose of this study was to characterize the central epithelial thickness (CET) of penetrating keratoplasty corneal specimens obtained from patients with keratoconus (KC) and correlate the histological patterns with their clinical history. METHODS: Ex vivo histological imaging was performed to measure CET and total corneal thickness (TCT) in 56 patients with KC. Microscopic slides from penetrating keratoplasty corneal specimens, stained with hematoxylin and eosin were evaluated using bright field microscopy. CET and TCT were measured, and morphological features were studied. Clinical history regarding duration of KC prior to surgery and length of and tolerance to contact lens wear were compared and analyzed. RESULTS: The microscopic slides of all patients available for follow up (n=48) were analyzed and CET and TCT were measured. The histological evaluation revealed 3 distinctive epithelial patterns. Pattern 1 with central hypertrophic and hydropic changes (n=19) measured 70.89±25.88µm in CET and 308.63±100.74µm in TCT; Pattern 2 (n=14) had not changed, similar to normal epithelium CET and TCT measuring 36.5±7.02µm and 260.14±87.93µm respectively. Pattern 3 (n=15) demonstrated thinner central epithelium characterized by atrophy and focal hydropic changes measuring 19.93±4.60µm and 268.00±79.39µm in CET and TCT respectively (all p<0.0001). The presence of Pattern 2 characterized by similar to normal CET was correlated with the duration of the condition (R=0.600, p=0.030). There was a significant difference in the length of CL wear comparing those with patterns 1 and 2 versus 3 (least no. of CL years) (p=0.05 and p=0.33 respectivelly). CONCLUSIONS: Patients with advanced disease have various central corneal epithelial changes detected with histology. Although each central epithelial pattern type was distinctive comparing the 3 patterns, there was no correlation with years of CL wear but only with the duration of the condition.

The contact Lens risk survey to assess risk of soft contact lens-related inflammatory events.

PURPOSE: To test the Contact Lens Assessment in Youth Contact Lens Risk Survey (CLRS) scoring algorithm in soft contact lens (SCL) wearers presenting with SCL-related adverse events and healthy matched controls. METHODS: This prospective case-control study compared CLRS responses in SCL wearers presenting with symptomatic red eyes (Cases) with age-, sex- and site-matched healthy SCL wearers (Controls) at six locations across North America. Responses to individual questions from Cases and Controls were analyzed using either the Pearson, Mantel-Haenszel chi-square, or Fisher's exact test. Differences in the CLRS scores were compared using t-tests. RESULTS: A total of 171 SCL wearers were enrolled (n = 57 Cases, 114 Controls). Cases were adjudicated to consensus and classified as contact lens-related serious and significant (S&S) or non-serious events. S&S Cases scored significantly higher on the CLRS (56.1 ±â€¯11.1) than either their matched Controls (44.3 ±â€¯11.1) (P <  0.001) or the non-Serious Cases (44.8± 12.8 P =  0.002). Scores of non-serious Cases were not significantly different than scores of their Controls (43.4 ± 10.7, P = 0.33) CONCLUSIONS: The CLRS scoring algorithm discriminated between SCL wearers presenting with S&S CL-related adverse events from healthy SCL wearers and those with non-serious events. This survey and scoring system could help practitioners identify patients at greatest risk for CL-related adverse events and support targeted interventions aimed at reducing risk behaviors.

Development of a contact Lens risk survey.

PURPOSE: To describe the development and report psychometric properties of the Contact Lens Risk Survey (CLRS) to identify patients at risk for soft contact lens-related complications. METHODS: Psychometric properties of the CLRS, a web-based survey with branching logic, were determined using data from 5 multi-site fieldings (n = 1059), including re-fielding to sub groups. Responses from participants with and without an active red eye were used to identify risk factors of a red eye event and calculate an overall risk score. A 6th fielding of the CLRS (n = 171) was used to assess discriminate validity. RESULTS: Participants needed 11-12 min to complete the survey with a negligible difference by age. Internal consistency was excellent (Cronbach's α ≥ 0.70) for 3 of the 5 constructs identified by factor analysis. Twelve of the 17 survey items exhibited excellent within-subject repeatability (Kappa ≥ 0.61). Between-subject agreement, assessed in 18-25 year olds, was high for the majority of items, suggesting good generalizability across different populations of SCL wearers. The ability of the model using individual items of the CLRS to discriminate Controls and participants with a red eye was good with an area under the curve of 0.779. CONCLUSION: The CLRS tool is a repeatable and valid instrument to standardize documentation of demographic, behavior, and exposure factors which appear to drive the greatest risk of a contact lens related red eye event.