Stress and Vision Fluctuations in Retinitis Pigmentosa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00475254
Recruitment Status : Completed
First Posted : May 21, 2007
Last Update Posted : April 6, 2011
National Institute of Nursing Research (NINR)
National Eye Institute (NEI)
Information provided by:
Johns Hopkins University

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.

Condition or disease
Retinitis Pigmentosa

Detailed Description:

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 such as duration of visual impairment, occupation, marital status, etc. The questionnaires are often used in research settings and sometimes in clinical settings. Many patients appreciate the opportunity to provide feedback since these areas are not always addressed as part of routine, clinical care. Focus group meetings, facilitated by Dr. George and Lori Edwards, will help us begin to understand factors are perceived to influence fluctuations in vision.

Subjects will participate in study procedures over the course of a 3 month period. This includes an enrollment visit at our center with lab-based vision tests, and then approximately 2 months PC-based vision testing.

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stress and Vision Fluctuations in Retinitis Pigmentosa
Study Start Date : August 2007
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals with a confirmed diagnosis of retinitis pigmentosa

Inclusion Criteria:

  • Patients with diagnosed retinitis pigmentosa

Exclusion Criteria:

  • Very severe vision loss (i.e., light perception only) who may have difficulty performing the vision tests with their home computers
  • Unable to use a PC (Personal Computer)
  • Non-English speaking
  • Unable to communicate experiences
  • Out of town for more than one week during a 2 month period when taking the PC-based tests

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00475254

United States, Maryland
Johns Hopkins WiImer Eye Insitute's Lions Vision Center
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
National Institute of Nursing Research (NINR)
National Eye Institute (NEI)
Principal Investigator: Ava K. Bittner, O.D., Ph.D. Johns Hopkins Wilmer Eye Institute
Principal Investigator: Maureen George, Ph.D. Johns Hopkins School of Nursing

Additional Information:
Responsible Party: Ava Bittner, OD, PhD, Johns Hopkins University Identifier: NCT00475254     History of Changes
Other Study ID Numbers: K23EY018356 ( U.S. NIH Grant/Contract )
First Posted: May 21, 2007    Key Record Dates
Last Update Posted: April 6, 2011
Last Verified: August 2008

Keywords provided by Johns Hopkins University:
Retinitis Pigmentosa
low vision

Additional relevant MeSH terms:
Retinitis Pigmentosa
Cone-Rod Dystrophies
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn