- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00475254
Stress and Vision Fluctuations in Retinitis Pigmentosa
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins WiImer Eye Insitute's Lions Vision Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Vision test reliability across multiple test administrations in relation to psychological and external factors
Time Frame: 2-3 months
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2-3 months
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Collaborators and Investigators
Sponsor
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
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K23EY018356 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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