Stress and Vision Fluctuations in Retinitis Pigmentosa

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00475254
First received: May 16, 2007
Last updated: April 5, 2011
Last verified: August 2008
  Purpose

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 Phase
Retinitis Pigmentosa
Phase 0

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stress and Vision Fluctuations in Retinitis Pigmentosa

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Vision test reliability across multiple test administrations in relation to psychological and external factors [ Time Frame: 2-3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2007
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Individuals with a confirmed diagnosis of retinitis pigmentosa

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475254

Locations
United States, Maryland
Johns Hopkins WiImer Eye Insitute's Lions Vision Center
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Ava Bittner, OD, PhD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00475254     History of Changes
Other Study ID Numbers: K23EY018356
Study First Received: May 16, 2007
Last Updated: April 5, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Retinitis Pigmentosa
stress
sleepiness
low vision
mind-body

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

ClinicalTrials.gov processed this record on July 20, 2014