Evaluation of Ocular Outcomes in Two 14-day Bed Rest Studies

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Analysis by NASA's VESGEN Software of Retinal Blood Vessels in Human Subjects Undergoing Head-Down Tilt During 70-Day Bed Rest

Significant risks for visual impairment associated with increased intracranial pressure (VIIP) are incurred by microgravity spaceflight, especially long-duration missions [1]. We hypothesize that microgravity-induced fluid shifts result in pathological changes within blood vessels of the retina that precede development of visual and other ocular impairments. Potential contributions of retinal vascular remodeling to VIIP etiology are therefore being investigated for two studies in 30deg infrared (IR) Heidelberg Spectralis(Registered Trademark) images with NASA's innovative VESsel GENeration Analysis (VESGEN) software [2,3]. The retrospective studies include: (1) before, during and after (pre, mid and post) 6 head-down tilt (HDT) in human subjects during 70 days of bed rest, and (2) before and after missions to the International Space Station (ISS) by U.S. crew members. Results for both studies are almost complete. A preliminary example for HDT is described below

Phase 3, Randomized, 20-Month Study of the Efficacy and Safety of Bimatoprost Implant in Patients with Open-Angle Glaucoma and Ocular Hypertension (ARTEMIS 2)

Objective- To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of 10 and 15 µg bimatoprost implant in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Methods- This randomized, 20-month, multicenter, masked, parallel-group, phase 3 trial enrolled 528 patients with OAG or OHT and an open iridocorneal angle inferiorly in the study eye. Study eyes were administered 10 or 15 µg bimatoprost implant on day 1, week 16, and week 32, or twice-daily topical timolol maleate 0.5%. Primary endpoints were IOP and IOP change from baseline through week 12. Safety measures included treatment-emergent adverse events (TEAEs) and corneal endothelial cell density (CECD). Results- Both 10 and 15 µg bimatoprost implant met the primary endpoint of noninferiority to timolol in IOP lowering through 12 weeks. Mean IOP reductions from baseline ranged from 6.2–7.4, 6.5–7.8, and 6.1–6.7 mmHg through week 12 in the 10 µg implant, 15 µg implant, and timolol groups, respectively. IOP lowering was similar after the second and third implant administrations. Probabilities of requiring no IOP-lowering treatment for 1 year after the third administration were 77.5% (10 µg implant) and 79.0% (15 µg implant). The most common TEAE was conjunctival hyperemia, typically temporally associated with the administration procedure. Corneal TEAEs of interest (primarily corneal endothelial cell loss, corneal edema, and corneal touch) were more frequent with the 15 than the 10 µg implant and generally were reported after repeated administrations. Loss in mean CECD from baseline to month 20 was ~ 5% in 10 µg implant-treated eyes and ~ 1% in topical timolol-treated eyes. Visual field progression (change in the mean deviation from baseline) was reduced in the 10 µg implant group compared with the timolol group. Conclusions- The results corroborated the previous phase 3 study of the bimatoprost implant. The bimatoprost implant met the primary endpoint and effectively lowered IOP. The majority of patients required no additional treatment for 12 months after the third administration. The benefit-risk assessment favored the 10 over the 15 µg implant. Studies evaluating other administration regimens with reduced risk of corneal events are ongoing. The bimatoprost implant has the potential to improve adherence and reduce treatment burden in glaucoma

Role of imaging in glaucoma diagnosis and follow-up

The purpose of the review is to provide an update on the role of imaging devices in the diagnosis and follow-up of glaucoma with an emphasis on techniques for detecting glaucomatous progression and the newer spectral domain optical coherence tomography instruments. Imaging instruments provide objective quantitative measures of the optic disc and the retinal nerve fiber layer and are increasingly utilized in clinical practice. This review will summarize the recent enhancements in confocal scanning laser ophthalmoscopy, scanning laser polarimetry, and optical coherence tomography with an emphasis on how to utilize these techniques to manage glaucoma patients and highlight the strengths and limitations of each technology. In addition, this review will briefly describe the sophisticated data analysis strategies that are now available to detect glaucomatous change overtime

Factors Affecting Cirrus-HD OCT Optic Disc Scan Quality: A Review with Case Examples

Spectral-domain OCT is an established tool to assist clinicians in detecting glaucoma and monitor disease progression. The widespread use of this imaging modality is due, at least in part, to continuous hardware and software advancements. However, recent evidence indicates that OCT scan artifacts are frequently encountered in clinical practice. Poor image quality invariably challenges the interpretation of test results, with potential implications for the care of glaucoma patients. Therefore, adequate knowledge of various imaging artifacts is necessary. In this work, we describe several factors affecting Cirrus HD-OCT optic disc scan quality and their effects on measurement variability

Determinants of agreement between the confocal scanning laser tomograph and standardized assessment of glaucomatous progression

Purpose: To estimate the agreement of confocal scanning laser tomograph (CSLT), topographic change analysis (TCA) with assessment of stereophotographs, and standard automated perimetry (SAP) for detecting glaucomatous progression and to identify factors associated with agreement between methods. Design: Observational cohort study. Participants: We included 246 eyes of 167 glaucoma patients, glaucoma suspects, and ocular hypertensives. Methods: We included CSLT series (n \u3c4 tests; mean follow-up, 4 years), stereophotographs, and SAP results in the analysis. The number of progressors by guided progression analysis (GPA, likely progression ), progressors by masked stereophotographs assessment and progressors by TCA as determined for 3 parameters related to the number of progressed superpixels within the disc margin was determined. Agreement between progression by each TCA parameter, stereophotographs and GPA was assessed using the Kappa test. Analysis of variance with post hoc analysis was applied to identify baseline factors including image quality (standard deviation of the mean topography), disc size and disease severity (pattern standard deviation [PSD] and cup area) associated with agreement/nonagreement between methods. Main Outcome Measures: Agreement in assessing glaucomatous progression between the methods including factors associated with agreement/nonagreement between methods. Results: Agreement between progression by TCA and progression by stereophotographs and/or GPA was generally poor regardless of the TCA parameter and specificity cutoffs applied. For the parameters with the strongest agreement, cluster size in disc (CSIZEdisc) and cluster area in disc (CAREAdisc), kappa values were 0.16 (63.9%, agreement on 134 nonprogressing eyes and 23 progressing eyes) and 0.15 (64.1%, agreement on 135 nonprogressing eyes and 22 progressing eyes) at 99% cutoff. Most of the factors evaluated were not significantly associated with agreement/nonagreement between methods (all P\u3e0.07). However, SAP PSD was greater in the progressors by stereophotography only group compared with the progressors by TCA only group (5.8±4.7 and 2.6±2.2, respectively [P = 0.003] for CSIZEdisc at 95% specificity and 5.4±4.6 and 2.5±2.3, respectively [P = 0.002] for CAREA disc at 99% specificity). Conclusions: Agreement for detection of longitudinal changes between TCA, stereophotography, and SAP GPA is poor. Progressors by stereophotography only tended to have more advanced disease at baseline than progressors by TCA only. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references. © 2010 American Academy of Ophthalmology