Training in Clinical Trials for Subjects with Low Vision

Johns Hopkins University, Baltimore MD

Investigators

Linked publications & trials

Abstract

[unreadable] DESCRIPTION (provided by applicant): The primary aim of this career training proposal is to train Ava Kiser, O.D. to become a successful, independent clinician-scientist, capable of performing high-quality clinical research in low vision. This goal will be accomplished through a mentored research project and didactic coursework leading to a PhD degree in clinical investigation. Two types of mentors will be involved in the training plan, related to 1) psychological evaluations and mindfulness-based stress reduction interventions for those with chronic disease; and 2) clinical trials, including data analysis statistics, study design and methodology. Numerous institutional resources will also play a supporting role during this training program. The candidate's research goals include the conduct of clinical trials in low vision, potentially involving Complementary and Alternative Medicine (CAM) or other interventions in visually impaired patients.. Negative psychological states such as distress, anxiety and depression are common in retinitis pigmentosa (RP) due to the chronic, slowly progressive nature of this disabling disease. Psychophysical vision measures are more variable in legally blind RP subjects than in normally sighted individuals, and RP patients indicate that variations in vision are often related to stress or fatigue. Short term research aims are to determine whether within and between day fluctuations in visual acuity, contrast sensitivity and visual field among RP patients are associated with perceived stress, sleepiness or negative mood states. This will be accomplished with at home PC-based questionnaires and vision tests, self-administered by the subjects at various times of the day and days of the week. We will also assess the impact of light exposure, sleep, and lab-induced pychosocial stress upon vision tests, to establish a profile of the characteristics of the RP subjects with the most variable vision. The candidate's training will include a small clinical trial to attempt to alleviate these factors in RP patients with a mind-body, cognitive-behavioral stress reduction intervention versus a control eye exercise program. Sources for the variability of vision measurements during future treatment clinical trials need to be identified and addressed before results can be properly assessed. This research may indicate the value of CAM-related interventions, and thus potentially improve the reliability of vision tests as outcome measures during future clinical trials and the quality of life for RP patients. [unreadable] [unreadable] [unreadable] [unreadable]