Success of Masking 5% Povidone-Iodine Treatment: The Reducing Adenoviral Patient Infected Days Study.

SIGNIFICANCE: The effectiveness of masking is rarely evaluated or reported in single- or double-masked clinical trials. Knowledge of treatment assignment by participants and clinicians can bias the assessment of treatment efficacy. PURPOSE: This study aimed to evaluate the effectiveness of masking in a double-masked trial of 5% povidone-iodine for the treatment of adenoviral conjunctivitis. METHODS: The Reducing Adenoviral Patient Infected Days study is a double-masked, randomized trial comparing a one-time, in-office administration of 5% povidone-iodine with artificial tears for the treatment of adenoviral conjunctivitis. Masking was assessed by asking participants and masked clinicians at designated time points if they believed the treatment administered was povidone-iodine or artificial tears, or if they were unsure. Adequacy of masking was quantified using a modified Bang Blinding Index. RESULTS: Immediately after treatment, 34% of participants who received povidone-iodine and 69% of those who received artificial tears guessed incorrectly or were unsure of their treatment (modified Bang Indices of 0.31 and -0.38, respectively). On day 4, 38% of the povidone-iodine participants and 52% of the artificial tear participants guessed incorrectly or were unsure of their treatment (modified Bang Indices of 0.24 and -0.05, respectively), indicating adequate and ideal masking. On days 1, 4, 7, 14, and 21, masked clinicians guessed incorrectly or were unsure of treatment in 53%, 50%, 40%, 39%, and 42% among povidone-iodine participants compared with 44%, 35%, 38%, 35%, and 39% among artificial tears participants, respectively. The modified Bang Indices for clinician masking in the povidone-iodine group ranged from -0.05 to 0.25 and from 0.13 to 0.29 in the artificial tears group. CONCLUSIONS: Masking of participants and clinicians was adequate. Successful masking increases confidence that subjective measurements are not biased. We recommend quantitative assessment and reporting the effectiveness of masking in ophthalmic clinical trials.

Diagnostic accuracy of clinical signs, symptoms and point-of-care testing for early adenoviral conjunctivitis.

CLINICAL RELEVANCE: This study identifies key signs and symptoms of acute conjunctivitis, that when combined with a point-of-care test, can improve clinician accuracy of diagnosing adenoviral conjunctivitis. BACKGROUND: Adenoviral conjunctivitis is a common ocular infection with the potential for high economic impact due to widespread outbreaks and subsequent furloughs from work and school. In this report, we describe clinical signs and participant-reported symptoms that most accurately identify polymerase chain reaction (PCR)-confirmed adenoviral conjunctivitis. METHODS: Adults with 'red eye' symptoms of four days or less were enrolled. Participants rated 10 ocular symptoms from 0 (not bothersome) to 10 (very bothersome), and indicated the presence or absence of systemic flu-like symptoms. Clinicians determined the presence or absence of swollen lymph nodes and rated the severity of eight ocular signs using a 5-point scale. An immunoassay targeting adenovirus antigen was utilised for the point-of-care test, and conjunctival swab samples were obtained for subsequent adenovirus detection by PCR analyses. Univariate and multivariate logistic regression models were used to identify symptoms and signs associated with PCR-confirmed adenoviral conjunctivitis. The diagnostic accuracy of these clinical findings, and the potential benefit of incorporating point-of-care test results, was assessed by calculating areas under the receiver operating characteristic curves (AUC). RESULTS: Clinician-rated bulbar conjunctival redness, participant-rated eyelid swelling and overall ocular discomfort had the best predictive value in the multivariate logistic regression model with an AUC of 0.83. The addition of the point-of-care test results to these three clinical sign/symptom scores improved diagnostic accuracy, increasing the AUC to 0.94. CONCLUSIONS: Conjunctival redness severity and participant-reported eyelid swelling and overall discomfort, along with adenoviral point-of-care test results, were highly predictive in identifying individuals with PCR-confirmed adenoviral conjunctivitis. Improved diagnostic accuracy by clinicians at the initial presenting visit could prevent unnecessary work furloughs and facilitate earlier treatment decisions.

Latanoprost-induced stabilization of central visual function in patients with primary open-angle glaucoma.

PURPOSE: Previous studies have demonstrated that visual function as measured by contrast sensitivity (CS) improves in primary open-angle glaucoma (POAG) patients following beta-blocker therapy and trabeculoplasty. There is evidence that ocular hypotensive agents, such as latanoprost, may provide benefit in terms of improved visual function, despite relatively small differences in the ocular hypotensive effect, when compared to other drugs. The aim of this study was to prospectively compare the effects of latanoprost and timolol maleate in Gelrite on CS. METHODS: Twenty (20) POAG patients on a monotherapy treatment regimen of topical beta blockade and with clinically stable intraocular pressure (IOP) were recruited for this single-masked, randomized, crossover study. Subjects were randomized to begin treatment with latanoprost 0.005% once-daily in the evening or timolol maleate 0.5% in Gelrite once-daily in the morning. At the end of a 3-month treatment period, each subject was crossed over to receive the alternative treatment for 3 months. Blood pressure, heart rate, IOP, and CS were assessed at baseline and after 4, 12, 16, and 24 weeks of treatment. Static central contrast sensitivity was evaluated at four spatial frequencies, 3, 6, 12, and 18 cycles/degree. Visual-field sensitivity was evaluated by using a commercially available program. Static threshold visual-field sensitivity was assessed at baseline and after 12 and 24 weeks of treatment. RESULTS: Subjects who were treated for 3 months with latanoprost, after being switched from timolol, experienced an improvement in CS at 3 cpd (P = 0.03). Conversely, subjects who were treated for 3 months with timolol, after being switched from latanoprost, demonstrated a significant loss in CS at 3 cpd (P = 0.04) and at 18 cpd (P = 0.03). Changes in CS occurred without a corresponding change in IOP, since there were no between-group differences (P > 0.05) at the end of each treatment phase. CONCLUSIONS: Compared with timolol maleate in Gelrite, latanoprost appears to significantly improve, or at least maintain, central visual function, as measured by CS, at different spatial frequencies in patients with POAG.

Aniseikonia testing in an adult population using a new computerized test, "the Aniseikonia Inspector".

PURPOSE: To determine the measurement characteristics of a new computerized test, the Aniseikonia Inspector Version 1, on a sample of clinic patients. METHODS: Aniseikonia was measured in the vertical, horizontal, and oblique meridians on 320 patients (mean 55 years old, range 17-89 years) prior to their optometric exam using the psychometric methods programmed into the Aniseikonia Inspector Version 1. Statistical analyses were performed to determine the distribution of aniseikonia in the sample of patients and the relationships between the amount of aniseikonia and patients' habitual refractive correction, visual acuity, stereopsis and binocular alignment status. The characteristics of the individual measurements were also examined. RESULTS: The means and standard deviations of the measured aniseikonia in the vertical, horizontal, and oblique meridians were -0.5% (2.5%), -0.1% (3.3%) and 0.3% (2.8%) respectively. The means in the vertical and oblique meridians were significantly different from 0.0 (p=0.0001, p=0.0314) while that in the horizontal was not (p=0.61). The distributions of aniseikonia showed that 65.6%, 57.5% and 64.3% had within +/-1.0% aniseikonia in the vertical, horizontal and oblique meridians, respectively. Correspondingly, 16.9%, 25.6% and 25.8% had aniseikonia of +/-3.0% or greater. The discrepancy between these percentages and those expected in a normal distribution indicate that the distributions were significantly more peaked than a normal distribution. This departure from normal is due to a few extreme values in the tails. The magnitude of aniseikonia had no statistically significant relationship with the patients' habitual refractive correction, visual acuity or stereopsis. The effect of phoria on the amount of aniseikonia was significant, more so for measurements in the horizontal meridian. The individual measurements, which are the average of two trials using the method of adjustment, showed no significant bias, no relationship between the means and differences in the two readings, but large differences between the two readings. Measurements in the vertical direction seem to be more stable than those in the other two meridians. CONCLUSION: As measured with the Aniseikonia Inspector 1.0, the majority of the patients sampled in this study exhibited 1.0% or less aniseikonia and were therefore not likely to have symptoms related to aniseikonia. At least 17% of patients had 3.0% or greater aniseikonia measured in the vertical meridian. The Aniseikonia Inspector warrants further evaluation in a clinical setting because of the large limits of agreement between the two settings that are average to determine the magnitude of the aniseikonia. These limits differ considerably from those established by the designers and, therefore, raise questions regarding the actual resolution of the instrument as compared to the nominal resolution.

Idiopathic amblyopia: a diagnosis of exclusion. A report of 3 patients.

PURPOSE: The aim of this study was to report the clinical course for 3 young patients diagnosed with idiopathic amblyopia. CASE REPORTS: The clinical course for 3 young patients with unilateral visual loss initially attributed to idiopathic amblyopia is presented. Extensive evaluations over the years, including optical coherence tomography, were performed in addition to routine clinical testing. In 1 patient, transient anisometropic refractive error during infancy was likely causative for the unilateral visual loss. For the second patient, a subclinical microtropia with varying eccentric fixation was subsequently diagnosed, and for the third patient, a subtle retinal disorder was subsequently diagnosed. CONCLUSION: The diagnosis of idiopathic amblyopia is one of exclusion and should only be made after extensive testing to rule out subclinical binocular vision or pathological anomalies.