Clinical Trial: Stress and Vision Fluctuations in Retinitis Pigmentosa

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Stress and Vision Fluctuations in Retinitis Pigmentosa

Brief Summary: Retinitis pigmentosa (RP) patients experience a slowly progressive, unpredictable loss of vision which eventually leads to bare or no light perception, posing a continuous threat to patients' independence. Negative psychological states such as distress, sleepiness, anxiety and depression are common in RP patients due to the nature of this chronic, 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. The primary goal of this research is to examine the vision fluctuations within and between days among RP patients using vision tests self-administered by patients through their home computers, and determine associations with factors such as perceived stress, mood states, sleepiness, or light exposure. The administration of questionnaires will allow us to gain some insight into which underlying psychological factors impact certain vision measures, allowing the design of future interventional research to attempt to reduce such factors. The aims of many future treatment clinical trials for RP will be to improve vision and/or reduce the rate of vision loss; thus the sources that lead to increased variability of vision need to be identified and alleviated to enable precise evaluation of interventions and improve patients' quality of life.

Detailed Summary:

An initial study visit for enrollment will take place at the Johns Hopkins Wilmer Eye Institute's Lions Vision Center. The investigators will enroll 50 RP subjects with vision better than hand motions or bare light perception, who are able to complete PC-based vision tests. Written informed consent for study participation will be obtained at the first study visit.

At home PC-based vision tests will be performed bi-weekly, for 2 months (i.e. 16 measures) to capture the full range of variability. Binocular visual acuity (VA), contrast sensitivity (CS) and visual field (VF) tests will be self-administered by the RP subjects, and will take ~10 minutes. Three brief questionnaires will be administered by PC after each vision test session: 1) Perceived Stress Scale (PSS); 2) Stanford Sleepiness Scale (SSS); and 3) Positive and Negative Affect Schedules (PANAS). Lab-based vision tests will take place at the time of enrollment, and will include: (1) distance best-corrected VA with the ETDRS charts, (2) Pelli-Robson letter CS, (3) Goldmann VF with V/4e and III/4e isopters, and (4) Humphrey 10-2 or 30-2 VF FastPac program. The vision tests and questionnaires are a part of routine clinical care.

After enrollment, The investigators will obtain information about psychological factors by administering the following questionnaires by phone on one occasion: Pittsburgh Sleep Quality Index, Emotional Stability, Beck Depression Inventory, the Self-Motivation Inventory, and the Life Experiences Survey. Questionnaires assessing health-related quality of life (SF-36) and mental status (MMSE) will also be administered. The investigators will use a phone version of the MMSE only for screening. Other variables that may be of importance to the study will be assessed through a complete patient medical, ocular and social history, including questions s
Sponsor: Johns Hopkins University

Current Primary Outcome: Vision test reliability across multiple test administrations in relation to psychological and external factors [ Time Frame: 2-3 months ]

Original Primary Outcome: Vision test reliability across multiple test administrations [ Time Frame: 6 months ]

Current Secondary Outcome:

Original Secondary Outcome: Changes in questionnaire scores (perceived stress, sleepiness, sleep quality, emotional stability, positive & negative mood states). [ Time Frame: 6 months ]

Information By: Johns Hopkins University

Dates:
Date Received: May 16, 2007
Date Started: August 2007
Date Completion:
Last Updated: April 5, 2011
Last Verified: August 2008