A potential primary endpoint for clinical trials in glaucoma neuroprotection.

The purpose of this retrospective, longitudinal study is to evaluate the relationship between MD slope from visual field tests collected over a short period of time (2 years) and the current United States' Food and Drug Administration (FDA) recommended endpoints for visual field outcomes. If this correlation is strong and highly predictive, clinical trials employing MD slopes as primary endpoints could be employed in neuroprotection clinical trials with shorter duration and help expedite the development of novel IOP-independent therapies. Visual field tests of patients with or suspected glaucoma were selected from an academic institution and evaluated based on two functional progression endpoints: (A) five or more locations worsening by at least 7 dB, and (B) at least five test locations based upon the GCP algorithm.

Blink: Characteristics, Controls, and Relation to Dry Eyes.

Blink is a complex phenomenon that is profoundly affected by diverse endogenous and exogenous stimuli. It has been studied in the context of cognition, emotional, and psychological states, as an indicator of fatigue and sleepiness, particularly in the automobile and transportation industry, in visual tasking, and finally, as it relates to tear film stability and ocular surface health. The fact that it is highly variable and has input from so many sources makes it very difficult to study.

Technical and clinical validation of the Allergen BioCube for timothy grass.

Introduction: Field studies for allergic rhinitis (AR) commonly have inconsistent allergen concentrations and subject exposure patterns due to varying environmental conditions and subject behaviors. A technical and clinical validation study was conducted for the Allergen BioCube using timothy grass to confirm uniform allergen concentration and clinically relevant subject symptom responses.

Methods: Allergen concentrations were verified by laser particle counts.

Technical and clinical validation of an environmental exposure unit for ragweed.

Background: Allergic rhinitis is a common condition, with ragweed pollen one of the more prevalent aeroallergens. Environmental exposure units such as the Allergen BioCube are valuable models for clinical allergy studies. A study was conducted to validate the Allergen BioCube for uniform ragweed pollen concentrations and clinically relevant sign and symptom responses to ragweed exposure.

Diurnal Tracking of Blink and Relationship to Signs and Symptoms of Dry Eye.

Purpose: To assess diurnal changes in the signs and symptoms of dry eyes and their relationship to diurnal interblink interval (IBI) in normal subjects and in subjects with dry eye.

Methods: Blink data were collected from 9:00 AM to 8:00 PM during 2 days of normal activity using an electrocardiogram monitoring device. All subjects recorded ocular discomfort (0-5 scale) and primary activity hourly each day in a diary.

Optimizing Reading Tests for Dry Eye Disease.

Purpose: The aim of this study was to evaluate the visual function information obtained from multiple reading tests in a dry eye population.

Methods: In this case-control, single-center clinical research center-based study, 15 subjects with dry eye (mean age 65 years) and 10 normal subjects (mean age 40 years) were included. The Standardized Mini-Mental Examination was given to assure that subjects had normal cognitive function.

Automated Grading System for Evaluation of Superficial Punctate Keratitis Associated With Dry Eye.

Purpose: To develop an automated method of grading fluorescein staining that accurately reproduces the clinical grading system currently in use.

Methods: From the slit lamp photograph of the fluorescein-stained cornea, the region of interest was selected and punctate dot number calculated using software developed with the OpenCV computer vision library. Images (n = 229) were then divided into six incremental severity categories based on computed scores.

The interblink interval in normal and dry eye subjects.

Purpose: Our aim was to extend the concept of blink patterns from average interblink interval (IBI) to other aspects of the distribution of IBI. We hypothesized that this more comprehensive approach would better discriminate between normal and dry eye subjects.

Methods: Blinks were captured over 10 minutes for ten normal and ten dry eye subjects while viewing a standardized televised documentary.

A single-center study evaluating the effect of the controlled adverse environment (CAE(SM)) model on tear film stability.

Purpose: To investigate use of an improved ocular tear film analysis protocol (OPI 2.0) in the Controlled Adverse Environment (CAE(SM)) model of dry eye disease, and to examine the utility of new metrics in the identification of subpopulations of dry eye patients.

Methods: Thirty-three dry eye subjects completed a single-center, single-visit, pilot CAE study.

Validation and verification of the OPI 2.0 System.

Purpose: The Ocular Protection Index (OPI) 2.0 System was developed to evaluate ocular surface protection under a natural blink pattern and normal visual conditions. The OPI 2.

Measurement of ocular surface protection under natural blink conditions.

Purpose: To evaluate a new method of measuring ocular exposure in the context of a natural blink pattern through analysis of the variables tear film breakup time (TFBUT), interblink interval (IBI), and tear film breakup area (BUA).

Methods: The traditional methodology (Forced-Stare [FS]) measures TFBUT and IBI separately. TFBUT is measured under forced-stare conditions by an examiner using a stopwatch, while IBI is measured as the subject watches television.

Diurnal variation of visual function and the signs and symptoms of dry eye.

Purpose: Subjects with dry eye often complain of disturbances in visual function and worsening of symptoms in the evening. To clinically substantiate these reports of diurnal variations, the present study tested subjects with dry eye on a series of visual function and ocular physiology measures.

Methods: Twenty-one subjects with dry eye were enrolled and underwent ophthalmic examinations, including best spectacle-corrected visual acuity, visual function decay as measured by the interblink interval visual acuity decay test without ocular anesthetic, reading rate test, slit-lamp biomicroscopy, and tear film breakup time.