Michael T.M. Wang

Comparison of Self-applied Heat Therapy for Meibomian Gland Dysfunction

Purpose To compare the effects on ocular temperature, lipid layer grade, tear film stability, and tear meniscus height after a single application of two commercially available warm compresses in mild-to-moderate dry eye and to report participant treatment preference. Methods Forty-one subjects with mild-to-moderate dry eye symptoms were enrolled in a randomized, paired-eye, investigator-masked trial. Heat was applied simultaneously to one eye (randomized) with a portable eye mask (EyeGiene) and to the contralateral eye with a microwave-heated flaxseed eye bag (MGDRx Eye Bag). Outer and inner eyelid temperatures, tear film lipid layer grade (LLG), and noninvasive tear film breakup time (NIBUT) were measured at baseline and immediately after 10 minutes of device application. Results Outer and inner eyelid temperatures, LLG, and NIBUT did not differ before treatment between eyes assigned to eye mask and eye bag therapy. All measurements were significantly increased from baseline, after warming with both devices (all p < 0.05). Outer and inner eyelid temperature changes were significantly greater with the eye bag than with the eye mask (outer eyelid, +3.5 ± 1.0°C vs. +2.4 ± 0.8°C; inner eyelid, +3.5 ± 1.0°C vs. +2.5 ± 0.9°C; all p < 0.001), although there was no significant difference in LLG and NIBUT improvement between treatments (all p > 0.05). A majority of subjects (78%) preferred the application of heat with the eye bag over the eye mask. Conclusions Both the EyeGiene mask and the MGDRx Eye Bag are convenient eyelid warming devices that result in clinically and statistically significant increases in NIBUT and LLG in patients with mild-to-moderate dry eye symptoms. The MGDRx Eye Bag is more effective in raising ocular temperature and is the preferred treatment method among subjects.

Exploring the Predisposition of the Asian Eye to Development of Dry Eye

PURPOSE To investigate the influence of eyelid shape on tear film quality, ocular surface characteristics and dry eye symptomatology by comparing Asian and Caucasian populations. METHODS Seventy-four age-matched participants were recruited in a cross-sectional study. Participants were classified into Asian single lid (ASL), Asian double lid (ADL), and Caucasian double lid (CDL) groups. Dry eye symptomatology, ocular surface characteristics, and tear film quality were evaluated in a single clinical session. RESULTS Meibomian gland dropout was significantly greater in both the ASL and ADL groups than in the CDL group (all P<.05). A greater proportion of ASL and ADL participants exhibited incomplete blinking than CDL patients (all P<.05). There were no significant differences in tear film quality and dry eye symptomatology between the three groups (all P>.05). Exposed ocular surface area, lissamine green staining, and lid wiper epitheliopathy were significantly greater in the ADL group compared to the CDL group (all P<.05). The CDL group displayed significantly greater anterior blepharitis and lid telangiectasia grades compared to both ASL and ADL groups (all P<.05). CONCLUSIONS A higher degree of meibomian gland dropout and incomplete blinking was observed in both Asian groups compared to the Caucasian group, potentially predisposing these groups to dry eye.

Responses of Specialist Societies to Evidence for Reversal of Practice

LESS IS MORE Responses of Specialist Societies to Evidence for Reversal of Practice Medical reversal—when a current practice is found to be no better than, or inferior to, a prior standard—is common1 and inconsistently translated into practice.2 Continuing use of ineffective treatments wastes resources and harms patients.3 There may be multiple reasons for persistence of reversed practices. Commercialentitiesmayresist evidence of reversal that threatens profitability.4 Academic and/or specialist biases might also contribute to persistence of reversed practices. Specialist societies strongly influence clinical practice in their specific disciplines.5 We analyzed the responses of specialist societies to publication of evidence for medical reversal.

Minimising instilled volume reduces the impact of fluorescein on clinical measurements of tear film stability

PURPOSE To compare clinical tear film break-up time measurements obtained non-invasively, with those measured following minimal and conventional volumes of fluorescein instillation. METHODS Forty-one subjects (20 male, 21 female, mean±SD age 34±11years), with or without dry eye, participated in a prospective cross-over study. Tear film break-up time was measured by the Tearscope Plus™ with fine grid insert. Measurements were made in triplicate, with no fluorescein instillation (NIBUT), then following application of a minimal volume of 1μl fluorescein from the Dry Eye Test™ (mTBUT), and finally with 15-30μl of fluid instilled via a conventional fluorescein strip (TBUT). A fifteen-minute interval between each set of measurements minimised the risk of residual contamination effects. RESULTS All three techniques displayed statistically significant pairwise correlation (all p<0.001). TBUT values were significantly shorter than both NIBUT (geometric mean 8.6s versus 10.9s, p=0.03) and mTBUT (geometric mean 8.6s versus 10.6s, p=0.03), and demonstrated narrower spread (both p<0.05). No significant differences were detected between NIBUT and mTBUT (all p>0.05). CONCLUSIONS Tear film break-up time values measured with conventional fluorescein instillation were shortened, while minimal fluorescein instillation and non-invasive methods produced comparable readings. This suggests that minimising instilled volumes can reduce the impact of fluorescein on clinical measurements of tear film stability.

Press Releases Issued by Supplements Industry Organisations and Non-Industry Organisations in Response to Publication of Clinical Research Findings: A Case-Control Study

Background Dietary supplement use is increasing despite lack of evidence of benefits, or evidence of harm. Press releases issued by the supplements industry might contribute to this situation by using ‘spin’ (strategies to hype or denigrate findings) to distort the results of clinical studies. We assessed press releases issued in response to publication of clinical studies on dietary supplements. Methods and Findings We analyzed 47 supplements industry press releases and 91 non-industry press releases and news stories, generated in response to 46 clinical studies of dietary supplements published between 1/1/2005 and 5/31/2013. The primary outcome was ‘spin’ content and direction. We also assessed disposition towards use of dietary supplements, reporting of study information, and dissemination of industry press releases. More supplements industry press releases (100%) contained ‘spin’ than non-industry media documents (55%, P<0.001). Hyping ‘spin’ scores were higher in industry than non-industry media documents for studies reporting benefit of supplements (median ‘spin’ score 3.3, 95% CI 1.0–5.5 vs 0.5, 0–1.0; P<0.001). Denigratory ‘spin’ scores were higher in industry than non-industry media documents for studies reporting no effect (6.0, 5.0–7.0 vs 0, 0–0; P<0.001) or harm (6.0, 5.5–7.5 vs 0, 0–0.5; P<0.001) from a supplement. Industry press releases advocated supplement use in response to >90% of studies that reported no benefit, or harm, of the supplement. Industry press releases less frequently reported study outcomes, sample size, and estimates of effect size than non-industry media documents (all P<0.001), particularly for studies that reported no benefit of supplements. Industry press releases were referenced by 148 news stories on the websites of 6 organizations that inform manufacturers, retailers and consumers of supplements. Conclusions Dietary supplements industry press releases issued in response to clinical research findings are characterized by ‘spin’ that hypes results that are favourable to supplement use and denigrates results that are not.

Temperature profiles of patient-applied eyelid warming therapies.

PURPOSE To compare temperature profile characteristics (on and off eye) of two patient-applied heat therapies for meibomian gland dysfunction (MGD): an eye mask containing disposable warming units (EyeGiene(®)) and a microwave-heated flaxseed eye bag(®) (MGDRx EyeBag(®)). METHODS In vitro evaluation: surface temperature profiles of activated eye masks and heated eye bags(®) (both n=10), were tracked every 10s until return to ambient temperature. Heat-transfer assessment: outer and inner eyelid temperature profiles throughout the eye mask and eye bag(®) treatment application period (10min) were investigated in triplicate. The devices were applied for 12 different time intervals in a randomised order, with a cool-down period in between to ensure ocular temperatures returned to baseline. Temperature measurements were taken before and immediately after each application. RESULTS In vitro evaluation: on profile, the eye bag(®) surface temperature peaked earlier (0±0 s vs. 100±20 s, p<0.001), cooled more slowly and displayed less variability than the eye mask (all p<0.05). Heat-transfer assessment: the eye bag(®) effected higher peak inner eyelid temperatures (38.1±0.4°C vs. 37.4±0.2°C, p=0.04), as well as larger inner eyelid temperature increases over the first 2 min, and between 9 and 10 min (all p<0.05). CONCLUSIONS The eye bag(®) surface temperature profile displayed greater uniformity and slower cooling than the eye mask, and was demonstrated to be significantly more effective in raising ocular temperatures than the eye mask, both statistically and clinically. This has implications for MGD treatment, where the melting points of meibomian secretions are likely to be higher with increasing disease severity.

Performance of contemporary surgical risk scores for transcatheter aortic valve implantation: A meta-analysis

BACKGROUND Transcatheter aortic valve implantation (TAVI) is considered for severe aortic valve disease at high and now intermediate risk for surgical aortic valve replacement. Risk stratification plays a critical role decision-making for intervention and modality. We compared the prognostic utility of surgical risk scores for TAVI in this meta-analysis. METHODS MEDLINE, Embase, Cochrane and Web of Science databases from 1 January 1980 to 31 December 2015 were searched. Studies were systematically reviewed for inclusion, and data extracted for pooled analyses. RESULTS Amongst 1688 articles searched, 47 full-text articles were screened and 24 studies (12,346 TAVI cases) included for analyses. Pooled c-statistics (95% confidence interval) for operative mortality were EuroSCORE 0.62 (0.57-0.67), EuroSCORE II 0.62 (0.59-0.66), STS Score 0.62 (0.59-0.65). Pooled calibration odds ratios (95%CI) were EuroSCORE 0.31 (0.25-0.38), EuroSCORE II 1.26 (1.06-1.51), STS 0.95 (0.72-1.27). C-statistics (95%CI) for 1-year mortality were EuroSCORE 0.62 (0.57-0.67), EuroSCORE II 0.66 (0.61-0.71) and STS Score 0.58 (0.53-0.64). CONCLUSION Surgical risk scores at most modestly discriminated operative and 1-year mortality. The EuroSCORE grossly over-estimated operative mortality while the EuroSCORE II and STS Scores fitted better to TAVI outcomes with their own limitations. There is a need for the development and validation of TAVI-specific risk models.

Compatibility of phospholipid liposomal spray with silicone hydrogel contact lens wear

PURPOSE To assess the effects of two weeks of regular phospholipid liposomal spray application on lipid layer grade, tear film stability, subjective comfort, visual acuity, and lipid deposition in silicone hydrogel contact lens wearers. METHODS Thirty-one existing contact lens wearers were enrolled and fitted with two week planned replacement silicone hydrogel contact lenses (Acuvue® Oasys®) in a prospective, randomized, paired-eye, investigator-masked trial. A phospholipid liposomal spray (Tears Again®) was applied to one eye (randomized) four times daily for two weeks. LogMAR high contrast visual acuity (VA), low contrast glare acuity (LCGA), non-invasive tear film break-up time (NIBUT), and lipid layer grade (LLG) were measured at baseline and day 14, in both treated and control eyes. Subjective comfort relative to baseline, and spectrofluorophotometric assessment of contact lens surface lipid deposition were also assessed on day 14. RESULTS All measurements did not differ at baseline between treated and control eyes. Lipid layer thickness and tear film stability were increased on day 14 in treated eyes (all p<0.05), but not in control eyes (all p>0.05). A greater proportion of participants reported improved comfort in the treated eye relative to the control eye (p=0.002). There were no significant differences in visual acuity or in contact lens surface lipid deposition, between treated and control eyes, on day 14 (all p>0.05). CONCLUSION The phospholipid liposomal spray increased tear film stability, lipid layer thickness and subjective comfort in silicone hydrogel contact lens wearers, without adversely affecting visual acuity or contact lens surface lipid deposition.

Exploring topical anti-glaucoma medication effects on the ocular surface in the context of the current understanding of dry eye

PURPOSE To assess tear film parameters, ocular surface characteristics, and dry eye symptomology in patients receiving topical anti-glaucoma medications. METHODS Thirty-three patients with a diagnosis of open angle glaucoma or ocular hypertension, receiving unilateral topical anti-glaucoma medication for at least 6 months, were recruited in a cross-sectional, investigator-masked, paired-eye comparison study. Tear film parameters, ocular surface characteristics, and dry eye symptomology of treated and fellow eyes were evaluated and compared. RESULTS The mean ± SD age of the participants was 67 ± 12 years, and the mean ± SD treatment duration was 5.3 ± 4.4 years. Treated eyes had poorer non-invasive tear film breakup time (p = 0.03), tear film osmolarity (p = 0.04), bulbar conjunctival hyperaemia (p = 0.04), eyelid margin abnormality grade (p = 0.01), tear meniscus height (p = 0.03), and anaesthetised Schirmer value (p = 0.04) than fellow eyes. There were no significant differences in dry eye symptomology, meibomian gland assessments, and ocular surface staining between treated and fellow eyes (all p > 0.05). CONCLUSIONS Adverse changes in tear film stability, tear osmolarity, conjunctival hyperaemia, and eyelid margins were observed in treated eyes. This suggests that inflammatory mechanisms may be implicated in the development of dry eye in patients receiving long term topical anti-glaucoma therapy.

Media Coverage, Journal Press Releases and Editorials Associated with Randomized and Observational Studies in High-Impact Medical Journals: A Cohort Study

Background Publication of clinical research findings in prominent journals influences health beliefs and medical practice, in part by engendering news coverage. Randomized controlled trials (RCTs) should be most influential in guiding clinical practice. We determined whether study design of clinical research published in high-impact journals influences media coverage. Methods and Findings We compared the incidence and amount of media coverage of RCTs with that of observational studies published in the top 7 medical journals between 1 January 2013 and 31 March 2013. We specifically assessed media coverage of the most rigorous RCTs, those with >1000 participants that reported ‘hard’ outcomes. There was no difference between RCTs and observational studies in coverage by major newspapers or news agencies, or in total number of news stories generated (all P>0.63). Large RCTs reporting ‘hard’ outcomes did not generate more news coverage than small RCTs that reported surrogate outcomes and observational studies (all P>0.32). RCTs were more likely than observational studies to attract a journal editorial (70% vs 46%, P = 0.003), but less likely to be the subject of a journal press release (17% vs 50%, P<0.001). Large RCTs that reported ‘hard’ outcomes did not attract an editorial more frequently than other studies (61% vs 58%, P>0.99), nor were they more likely to be the subject of a journal press release (14% vs 38%, P = 0.14). Conclusions The design of clinical studies whose results are published in high-impact medical journals is not associated with the likelihood or amount of ensuing news coverage.