Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00475254
Status:
COMPLETED
Last Update Posted:
2011-04-06
First Post:
2007-05-16
Brief Title:
Stress and Vision Fluctuations in Retinitis Pigmentosa
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Stress and Vision Fluctuations in Retinitis Pigmentosa
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 Description:
An initial study visit for enrollment will take place at the Johns Hopkins Wilmer Eye Institutes 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 ie 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 V4e and III4e 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
At home PC-based vision tests will be performed bi-weekly for 2 months ie 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 V4e and III4e 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None