Vaginal and Rectal microbiome changes following administration of a multi-species antenatal probiotic: A randomized control trial.

The gut and vaginal microbiome undergo changes during pregnancy which may be protective or harmful to the birthing person. Probiotics have been found to cause protective changes to the gut and vaginal microbiomes, with the potential to improve perinatal outcomes. This randomized control trial compares the vaginal and rectal microbiomes before and after an antenatal probiotic or placebo intervention, with a diverse group of pregnant people and a special focus on racial disparities. The vaginal and rectal microbiomes reveal non-significant increased Lactobacillus in the probiotics group, with a greater increase in participants who identified as Black. Potential implications and future study are discussed.

Antimicrobial effects of blue light therapy against cutibacterium acnes: optimal dosing and impact of serial treatments.

Background: Blue light therapy (BLT) is a Food and Drug Administration cleared modality used in dermatology as an effective treatment of acne. The primary purpose of this study is to determine if there are dose-dependent antimicrobial effects of BLT against Cutibacterium acnes (C. acnes). Methods: A known strain of C. acnes was grown on chocolate agar in a controlled laboratory environment under anaerobic conditions for 1 week. After 1 week, 2-3 colonies of C. acnes were isolated and transferred to broth medium to incubate for 2 or 7 days. Broth vials (treatment arm) then underwent 1 of 6 different blue light dosing treatment regimens and a duplicate broth vial served as a control left open to the same environment. The BLT regimens were a single treatment of 25 J/cm2, 50 J/cm2, 75 J/cm2, 100 J/cm2, 2 serial treatments of 50 J/cm2 separated by 24 hours, or 2 serial treatments of 75 J/cm2 separated by 24 hours. The Omnilux Blue device (415 nm wavelength) was used for all BLT treatments and delivered, on average, 1.68 ± 0.004 J/min. Following treatment, the control and treatment broth samples were plated on chocolate agar and allowed to grow for 7 days. After 7 days, plates were counted and colony forming units (CFUs) were calculated. Six trials were completed for each BLT dosing regimen based on an a priori power analysis of 6 individual 2-sided t-tests. Comparisons in the primary outcome were made via mixed-effects analysis of variance with replicate as a random effect. Results: All BLT treatment regimens resulted in significantly fewer CFUs than their aggregate control plate CFUs (P < .05 for all). Furthermore, in 2-way comparison of CFUs between BLT treatment groups, a single treatment of 75 J/cm2 did lead to significantly less growth than 25 J/cm2 (P = .017) and 50 J/cm2 (P = .017). There were no improved antimicrobial effects with serial treatments when comparing 2 doses of 50 J/cm2 with a single dose of 100J/cm2, nor were 2 doses of 75 J/cm2 more efficacious than 100 J/cm2. Using the Omnilux Blue device, it took 44.8 minutes to deliver a 75 J/cm2 dose. Conclusion: BLT is an effective antimicrobial agent against this single virulent strain of C. acnes. Treatment dosing of 75 J/cm2 was identified to be the most effective dose per unit time. Serial treatments did not lead to superior antimicrobial effects over a single, high-dose treatment.

Quality improvement study on the effectiveness of intranasal povidone-iodine decolonization on surgery patients.

Background: Surgical site infection prevention and treatment remains a challenge in healthcare settings globally. The routine use of intranasal mupirocin for decolonization has challenges and preoperative intranasal povidone-iodine decolonization is another option. The purpose of this quality improvement study was to assess if a one-time preoperative intranasal povidone-iodine application could reduce the risk of the likelihood of nasal carriage of Staphylococcus aureus after surgery. Methods: Ambulatory Surgery Center patients were enrolled in an intranasal povidone-iodine decolonization quality improvement study as they reported at the pre-operative holding area. Pre-decolonization intranasal samples were collected, followed by intranasal application of povidone-iodine. Patients waited for a minimum of 20 minutes after application before proceeding with surgery. Nasal samples were again collected after surgery. Each sample was tested for S. aureus colonization using the 16S rRNA-mecA-nuc triplex polymerase chain reaction, standard biochemical tests, and qualitative culturing. Findings: In the 98 patients enrolled, 36% of these patients had intranasal colonization with S. aureus by 16S rRNA-mecA-nuc triplex polymerase chain reaction before surgery. Using a qualitative culture technique, 28% of patients tested positive for S. aureus before surgery and 20% of patients tested positive for S. aureus after surgery (P = 0.039). Conclusion: Intranasal preoperative povidone-iodine is an effective strategy in the decolonization of S. aureus from the nares if properly implemented.

Are aerosols generated during lung function testing in patients and healthy volunteers? Results from the AERATOR study.

Pulmonary function tests are fundamental to the diagnosis and monitoring of respiratory diseases. There is uncertainty around whether potentially infectious aerosols are produced during testing and there are limited data on mitigation strategies to reduce risk to staff. Healthy volunteers and patients with lung disease underwent standardised spirometry, peak flow and FENO assessments. Aerosol number concentration was sampled using an aerodynamic particle sizer and an optical particle sizer. Measured aerosol concentrations were compared with breathing, speaking and voluntary coughing. Mitigation strategies included a standard viral filter and a full-face mask normally used for exercise testing (to mitigate induced coughing). 147 measures were collected from 33 healthy volunteers and 10 patients with lung disease. The aerosol number concentration was highest in coughs (1.45-1.61 particles/cm3), followed by unfiltered peak flow (0.37-0.76 particles/cm3). Addition of a viral filter to peak flow reduced aerosol emission by a factor of 10 without affecting the results. On average, coughs produced 22 times more aerosols than standard spirometry (with filter) in patients and 56 times more aerosols in healthy volunteers. FENO measurement produced negligible aerosols. Cardiopulmonary exercise test (CPET) masks reduced aerosol emission when breathing, speaking and coughing significantly. Lung function testing produces less aerosols than voluntary coughing. CPET masks may be used to reduce aerosol emission from induced coughing. Standard viral filters are sufficiently effective to allow guidelines to remove lung function testing from the list of aerosol-generating procedures.

The influence of corneoscleral topography on soft contact lens fit.

PURPOSE: To evaluate the influence of peripheral ocular topography, as evaluated by optical coherence tomography (OCT), compared with traditional measures of corneal profile using keratometry and videokeratoscopy, on soft contact lens fit. METHODS: Ocular surface topography was analyzed in 50 subjects aged 22.8 years (SD ±5.0) using videokeratoscopy (central keratometry, corneal height, and shape factor) and OCT to give both full sagittal cross-sections of the cornea and cross-sections of the corneoscleral junctions. Corneoscleral junction angle, corneal diameter, corneal sagittal height, and scleral radius were analyzed from the images. Horizontal visible iris diameter and vertical palpebral aperture were analyzed from digital slit lamp images. Lens fit was graded after 30 minutes wear of a -2.50 D commercially available standard hydrogel (etafilcon A, modulus 0.30 MPa) and silicone hydrogel (galyfilcon A, 0.43 MPa) design of similar geometries (8.30-mm base curve, 14.0-mm diameter). RESULTS: The mean horizontal corneal diameter was 13.39 mm (SD ±0.44). In many cases, there was a tangential transition at the corneoscleral junction. The corneoscleral shape profile analyzed from cross-sectional OCT images contributed significantly (P < 0.001) to the prediction of soft contact lens fit compared with keratometry and videokeratoscopy, accounting for up to 24% of the variance in lens movement. The fit of the stiffer material silicone hydrogel lens was better able to be predicted and was more varied than the hydrogel contact lens. CONCLUSIONS: The extra peripheral corneoscleral data gained from OCT characterization of ocular surface architecture provide valuable insight into soft contact lens fit dynamics.

Characterization of soft contact lens edge fitting using ultra-high resolution and ultra-long scan depth optical coherence tomography.

PURPOSE: To characterize the edge fitting of soft contact lenses using ultra-high resolution optical coherence tomography (UHR-OCT) and ultra-long scan depth optical coherence tomography (UL-OCT). METHODS: A total of 20 participants (11 men, 9 women; mean age, 32.3 years) were recruited. Four different types of soft contact lenses were randomly fitted to both eyes of each subject on two separate visits. After 30 minutes, the horizontal meridians of the corneal center, midperiphery, and limbus were imaged by UHR-OCT. UL-OCT imaged each lens in vitro and the ocular surface of a physical model eye. RESULTS: Angle-edged lenses had significantly less conjunctival buildup than did round-edged lenses (P = 0.008). Limbal post-lens tear film gaps were present in 42% of the eyes, with the round-edged lenses having the most at 68%. Similarly, post-lens tear film gaps at the corneal mid-periphery were present in 47% of all eyes, with the round-edged lens having the most at 75%. Mismatches between the lens and the ocular surface were simulated based on UL-OCT images of the in vitro lenses and the model eye. The existence of tear film gaps and touching points were predicted in the simulation. CONCLUSIONS: The soft contact lens edge fitting was characterized by the conjunctival buildup and tear film gaps. Different types of contact lenses presented different levels of conjunctival buildup as well as different frequencies of tear film gaps. The findings by UHR-OCT were predicted in the simulation by UL-OCT. The application of these new technologies may open new ways of designing lenses and evaluating their fit.

Patient attitudes and behavior regarding hygiene and replacement of soft contact lenses and storage cases.

PURPOSE: To review important aspects of contact lens compliance and to survey contact lens replacement frequency, steps in lens care and hygiene and replacement of the lens storage case via online surveys. METHODS: Random US samples (n=645 and 787) of frequent replacement contact lens wearers answered questions on contact lens wear in online, sponsor-masked surveys. RESULTS: Wearers of lenses prescribed by their practitioner for 2 weekly replacement reported that they replaced lenses as follows: within 2 weeks 45%, within 3 weeks (minor stretching) 68%, within 4 weeks 89%, ≥8 weeks (extreme stretching) 4%, compared to Monthly wearers who reported: within 4 weeks 37%, within 5 weeks (minor stretching) 57%, ≥8 weeks 23% (≥8 weeks extreme stretching, Chi-square p=0.001). Median frequency for cleaning lens storage case was 2-3 times per week, while 33% reported cleaning monthly or less often. Median lens storage case replacement was every 4-6 months, while 48% reported annual replacement or less often. Most patients cleaned their lens case with hot or cold tap water (72%). CONCLUSIONS: These internet surveys revealed significant non-compliance with lens care steps, case hygiene and lens replacement schedule. More than half of the contact lens wearers surveyed were not compliant with their 2-weekly or monthly schedule. Lenses prescribed for longer replacement intervals can lead to more extreme stretching of lens life. To encourage better patient habits, eye care providers should reinforce their recommended frequency of replacement of lenses and storage cases and should reinforce care and hygiene steps at each patient visit.

Hydrogel lens comfort in challenging environments and the effect of refitting with silicone hydrogel lenses.

PURPOSE: The purpose of this analysis was to measure the proportion of soft contact lens wearers who wear lenses in challenging environments and to evaluate their resulting comfort in those conditions. A second objective was to determine whether refitting with silicone hydrogel lenses affects lens comfort among subjects who wear lenses in these environments. METHODS: Baseline data were collected from 496 hydrogel soft lens wearers on the frequency of use of contact lenses and the associated comfort in 12 challenging environments. Subjects were then refit into second generation silicone hydrogel lenses: senofilcon A (n = 228), galyfilcon A (n = 132), or lotrafilcon B (n = 136). Comfort responses were compared for subjects who "always" or "frequently" used lenses in the queried environments after 2 weeks of silicone hydrogel daily lens wear. RESULTS: More than 80% of subjects used habitual lenses "always" or "frequently" while reading, sitting in an air-conditioned or heated car, using a computer and while driving at night. Less than 40% used lenses "always" or "frequently" while riding in an airplane, at high altitudes, or while napping or sleeping. The least comfortable environments were in dusty, polluted or smoky environments (30% comfortable), and the most comfortable were while reading and using a computer. After 2 weeks use of senofilcon A and galyfilcon A lenses, comfort in all environments improved significantly (Wilcoxon signed rank) except for using a computer with galyfilcon A. After 2 weeks with lotrafilcon B lenses, there was improved comfort while using lenses in all environments except driving at night, using a computer and sitting in an air-conditioned or heated car (p < 0.04, Wilcoxon signed rank). CONCLUSIONS: Daily wear contact lens wearers limit use of lenses during air travel or while napping. Use of daily wear silicone hydrogel lenses improved comfort significantly in most environments, allowing subjects to wear them in challenging environments.

Baseline factors predictive of incident penetrating keratoplasty in keratoconus.

PURPOSE: To identify baseline demographic and clinical factors associated with undergoing penetrating keratoplasty (PK) in a prospective cohort of 1,065 keratoconus patients followed for eight years in the Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study. DESIGN: Multicenter, prospective, observational cohort study. METHODS: We report the rate of PK over eight years and baseline factors predictive of PK in 1,065 patients who, at the time of study enrollment, had not undergone PK in either eye. RESULTS: Eighty-two percent of patients completed the eight-year close-out visit. Twelve percent (126 of 1,065) had PK in one (9.3%) or both eyes (2.5%). Baseline factors associated with increased likelihood of PK included younger age, steeper keratometric values, worse visual acuity, corneal scarring, poorer contact lens comfort, and poorer vision-related quality of life. The percent of eyes undergoing PK was 15% for patients 40 years old and younger, 28% for eyes with a steep keratometric value greater than 52 diopters, 33% for visual acuity less than 20/40, and 24% for eyes with corneal scarring. CONCLUSIONS: The CLEK Study confirmed previous reports of the increased likelihood of PK associated with corneal scarring, steeper keratometry values, poorer visual acuity, and poorer contact lens comfort. The CLEK Study is among the first to report an increased risk of PK associated with younger age, worse vision-related quality of life, and flatter contact lens fits. Knowledge of these factors is beneficial to clinicians in patient education and may be useful in disease management.

Prevalence of ocular surface symptoms, signs, and uncomfortable hours of wear in contact lens wearers: the effect of refitting with daily-wear silicone hydrogel lenses (senofilcon a).

PURPOSE: Many soft contact lens wearers have symptoms or signs that compromise successful lens wear. This study estimated the prevalence of problems in current wearers of soft contact lenses and tested the effect of refitting patients with senofilcon A silicone hydrogel lenses (ACUVUE Oasys). METHODS: Prevalence was estimated from 1,092 current lens wearers for frequent or constant discomfort or dryness, at least 2 hours of uncomfortable wear, at least grade 2 limbal or bulbar hyperemia (0-4), or at least grade 3 corneal staining (0-15). In the second part of the study, 112 of the 564 wearers classified as problem patients were refitted with senofilcon A lenses and reassessed 2 weeks later. RESULTS: Fifty-two percent (564 of 1,092) had some qualifying criteria, with dryness reported by 23%, discomfort by 13%, and at least 2 hours of uncomfortable wear by 27%. Six percent of subjects had qualifying limbal hyperemia; 10% had bulbar hyperemia; and 12% had corneal staining. After refitting 112 problem patients, 75% had less dryness; 88% had better comfort (P<0.0001 each); and 76% had fewer uncomfortable hours of wear (P=0.004). Although the average wearing time was unchanged, comfortable wearing time increased significantly (10.4 to 11.6 hours) (P=0.004). All (35 of 35) eyes with qualifying limbal hyperemia before the refit also improved (P<0.0001), as did 80% (40 of 50) of those with bulbar hyperemia (P<0.0001) and 76% (26 of 34) of those with corneal staining (P=0.005). CONCLUSIONS: Most soft lens wearers encounter clinically significant signs or symptoms with their current contact lenses. Refitting with new-generation silicone hydrogel lenses (senofilcon A) can alleviate some of these common problems.

Longitudinal changes in visual acuity in keratoconus.

PURPOSE: The present investigation aimed to identify factors that predict reduced visual acuity in keratoconus from a prospective, longitudinal study. METHODS: This report from the Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study used 7 years of follow-up data from 953 CLEK subjects who did not have penetrating keratoplasty in either eye at baseline and who provided enough data to compute the slope of the change over time in high- or low-contrast best-corrected visual acuity (BCVA). Outcome measures included these slopes and whether the number of letters correctly read decreased by 10 letters or more in at least one eye in 7 years. RESULTS: Mean age of the subjects at the first follow-up visit was 40.2 +/- 11.0 years (mean +/- SD). Overall, 44.4% were female, and 71.9% were white. The slope of the change in high- and low-contrast BCVA (-0.29 +/- 1.5 and -0.58 +/- 1.7 letters correct/year, respectively) translated into expected 7-year decreases of 2.03 high- and 4.06 low-contrast letters correct. High- and low-contrast visual acuity decreases of 10 or more letters correct occurred in 19.0% and 30.8% of subjects, respectively. Independent predictors of reduced high- and low-contrast BCVA included better baseline acuity, steeper first definite apical clearance lens (FDACL), and fundus abnormalities. Each diopter of steeper baseline FDACL predicted an increased deterioration of 0.49 high- and 0.63 low-contrast letters correct. CONCLUSIONS: CLEK Study subjects with keratoconus exhibited a slow but clear decrease in BCVA during follow-up, with low-contrast acuity deteriorating more rapidly than high-contrast. Better baseline BCVA, steeper FDACL, and fundus abnormalities were predictive of greater acuity loss with time.

Estimation of the incidence and factors predictive of corneal scarring in the Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study.

PURPOSE: The multicenter Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study is a prospective, observational study of 1209 keratoconus patients. We report methods to define incident corneal scarring and baseline factors predictive of incident corneal scarring in nonsurgical eyes of CLEK Study keratoconus patients through their fifth year of follow-up. METHODS: Of the 1,209 patients, 878 patients with at least one unscarred cornea at baseline were included in this study. The cumulative 5-year incidence of scarring is defined as the proportion of patients who developed central corneal opacification as detected by a clinician examining the patient with a slit-lamp biomicroscope and by masked readings of corneal photographs at the CLEK Photography Reading Center. Logistic regression analysis was used to test for relationships between baseline factors and incident corneal scarring. Baseline factors analyzed included age, sex, race, atopic disease, contact lens wear, family history of keratoconus, corneal curvature, and central corneal fluorescein staining, among others. RESULTS: The 5-year incidence of corneal scarring was 13.7% (120 of 878) overall, 16.7% (102 of 609) for contact lens-wearing eyes, and 38.0% (46 of 121) for contact lens-wearing eyes with corneal curvature greater than 52 D. Baseline factors predictive of incident scarring included corneal curvature greater than 52 D (odds ratio [OR] = 4.79; 95% confidence interval [CI], 3.08, 7.45; P < 0.001), contact lens wear (OR = 2.50; 95% CI, 1.40, 4.76; P = 0.003), marked corneal staining (OR = 2.38; 95% CI, 1.49, 3.76; P = 0.0002), and age less than 20 years (OR = 6.34; 95% CI, 2.57, 15.00; P < 0.0001). CONCLUSIONS: Multivariate analyses of 5-year prospective data from the CLEK Study cohort showed that baseline corneal curvature, contact lens wear, corneal staining, and younger age were predictive of the development of corneal scarring. The 5-year incidence of scarring is 13.7% for the overall sample and 38.0% for those eyes with corneal curvature greater than 52 D that wore contact lenses. Contact lens wear increased the risk of incident scarring more than 2-fold. These findings suggest a causal contribution of contact lens wear to corneal scarring in keratoconus and imply that corneal scarring might be reduced by modifying the contact lens fit.

The impact of lens choice in the relief of contact lens related symptoms and ocular surface findings.

PURPOSE: The aim of this study was to compare the efficacy of hioxofilcon A and omafilcon A soft contact lenses for the reduction of signs and symptoms of contact lens related dryness among contact lens wearers who presented with symptoms and signs at baseline. METHODS: Forty dry eye subjects, 37 females and 3 males, were enrolled in this prospective, single-center, randomized, contra-lateral, cross-over study. Subjects were randomly dispensed hioxifilcon A and omafilcon A lenses for contra-lateral eyes. Lenses were worn daily wear for 3 months; for 6 weeks (2-week lens replacement) then lens types were crossed over to opposite eyes for 6 more weeks. Clinical examinations took place at baseline, 1 and 6 weeks in each cycle. Ocular surface signs and symptoms were evaluated by self-administered questionnaire. RESULTS: Compared to baseline symptoms with habitual lenses, dryness, discomfort, and blurry vision were reported at a lower frequency and intensity with both test lens types (p < 0.05, all comparisons, Wilcoxon Signed Ranks Test). Compared to baseline signs, there was an improvement in overall fluorescein staining for both lenses (p < 0.05). Lissamine green staining showed improvement with omafilcon A lenses only (p < 0.05). There was no change in tear break up time or bulbar redness. CONCLUSION: Symptoms and ocular surface staining associated with contact lens related dryness can be significantly alleviated by the use of hioxofilcon A or omafilcon A lenses, which yielded similar findings in this study.

Survey of contact lens-wearing habits and attitudes toward methods of refractive correction: 2002 versus 2004.

PURPOSE: The purpose of this study is to measure patient attitudes toward methods of refractive correction among cross-sectional populations of contact lens wearers in 2002 and 2004 at the School of Optometry contact lens clinic at Indiana University. We also assessed the role of age and gender on these attitudes. METHODS: Attitudes toward methods of refractive correction were surveyed among 349 consecutive contact lens wearers in the spring of 2002 and compared with surveyed attitudes among 99 contact lens wearers in the winter of 2004. The 23 questions in the survey queried attitudes on the health and safety, cost, and interest in methods of refractive correction in addition to questions about the wearing schedule for the subjects' current contact lenses (CL). Refractive methods that were compared included glasses, daily wear CL (DW), 7-day extended wear (EW) CL, 30-day continuous wear (CW) CL, LASIK, and orthokeratology (OK). The proportion of answers citing "agree" or "strongly agree" were combined and analyzed by chi-squared tests comparing the results for stratified groups in the previous and the current survey. The groups were stratified by gender and age over of under 30 years. Significance level was set at p < or = 0.05. RESULTS: In the 2004 survey, the age of the subjects was significantly younger. Subjects' interest in EW increased significantly in 2004 (59% vs. 45% with high level of interest 2004 vs. 2002, respectively; p = 0.015) and the proportion of subjects reporting overnight wear increased significantly (DW = 58% vs. 69% 2004 vs. 2002, p = 0.0017, controlling for age and gender). In 2004, glasses and EW CL were rated as more healthy compared with 2002 (glasses 95% vs. 88%, p = 0.05; EW CL 48% vs. 34%, p = 0.005). Males are now less likely in 2004 to rate EW as healthy compared with females (38% vs. 53%, p = 0.01). In the 2004 survey, subjects over age 30 were significantly less interested in LASIK compared with those under age 30 (59% vs. 33%, p = 0.02) and less interested than they were in 2002. CONCLUSIONS: In the 2004 survey, significantly more subjects reported overnight lens wear, an increased interest in, and opinion of overnight wear as a healthy method of refractive correction compared with the 2002 survey. There was some dampening of enthusiasm for LASIK among subjects over 30 years of age in the 2004 survey. Age and gender can influence attitudes toward refractive correction, with females in this sample showing the most change over time, most probably as a result of different health information sources used by various demographic groups.

Forms of vision correction: demographic factors in patient attitudes and perceptions.

PURPOSE: To evaluate attitudes toward current treatments for vision correction in a clinical population of adults wearing spectacles and contact lenses (CLs). METHODS: Patients seen in the Indiana University Contact Lens and Primary Care Clinics in the spring of 2002 completed multiple-choice questionnaires evaluating their current device for vision, comfort, convenience, health and safety, cost, and overall satisfaction. They also rated their interest in and the convenience and health and safety of 30-day continuous wear (CW), 7-day extended wear (EW), modern orthokeratology, and LASIK and were given a forced choice on their preferred method of vision correction. RESULTS: Three hundred forty-nine CL and 177 primary care patients completed questionnaires. Subjects reported high satisfaction with their current treatment. Seventy percent of glasses wearers were neutral or not interested in CLs or LASIK. CL patients were interested or very interested in orthokeratology (70%) followed by LASIK (65%), 7-day EW (51%), and 30-day CW (44%). Age and sex were the most significant factors that influenced wearing practices and attitudes, with males (especially young) indicating significantly higher use of EW than females (P = 0.0005, chi(2)). Males were also more interested in 7-day EW (P = 0.011) and 30-day CW (P = 0.001) and rated their health and safety higher (P = 0.045 and P = 0.003, respectively). CONCLUSIONS: In the spring of 2002, many of these patients remained cautious about the health and safety of 7-day EW and 30-day CW CLs.