Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT00475254
Study type Observational
Source Johns Hopkins University
Contact
Status Completed
Phase Phase 0
Start date August 2007
Completion date April 2011

See also
  Status Clinical Trial Phase
Recruiting NCT01432847 - Cell Collection to Study Eye Diseases
Completed NCT04983914 - Retrospective NIS to Evaluate the Patient Benefit of TES
Recruiting NCT03845218 - Retinitis Pigmentosa Clinical Measures and Repeatability Testing of Potential Outcome Measures
Completed NCT00231010 - Molecular Genetics of Retinal Degenerations
Active, not recruiting NCT04611503 - PDE6A Gene Therapy for Retinitis Pigmentosa Phase 1/Phase 2
Completed NCT02909985 - Visual Activity Evoked by Infrared in Humans After Dark Adaptation N/A
Recruiting NCT01914913 - Clinical Study to Evaluate Safety and Efficacy of BMMNC in Retinitis Pigmentosa Phase 1/Phase 2
Completed NCT01949623 - Biomarkers In Retinitis Pigmentosa (BIRP) N/A
Completed NCT01835002 - Transcorneal Electrical Stimulation - Multicenter Safety Study N/A
Completed NCT00407602 - Argus® II Retinal Stimulation System Feasibility Protocol N/A
Completed NCT00515814 - Retina Implant Pilot Trial to Evaluate Safety & Efficacy in Blind Patients Having Degenerated Photo-receptors N/A
Completed NCT00100230 - DHA and X-Linked Retinitis Pigmentosa Phase 2
Active, not recruiting NCT00378742 - Repository for Inherited Eye Diseases
Terminated NCT05085964 - An Open-Label Extension Study to Evaluate Safety & Tolerability of QR-421a in Subjects With Retinitis Pigmentosa Phase 2
Recruiting NCT05805007 - Safety and Tolerability Study of Gene Editing Drug ZVS203e in Participants With Retinitis Pigmentosa Early Phase 1
Recruiting NCT06291935 - Safety and Tolerability of Intravitreal Administration of VG901 in Patients With Retinitis Pigmentosa Due to Mutations in the CNGA1 Gene Phase 1
Recruiting NCT05909488 - Role of UC-MSC and CM to Inhibit Vision Loss in Retinitis Pigmentosa Phase I/II Phase 2/Phase 3
Recruiting NCT03078309 - The Effects of Cannabis on Visual Functions in Healthy and Retinitis Pigmentosa Patients Early Phase 1
Completed NCT04238858 - Effects of Subtenon-injected Autologous Platelet-rich Plasma on Visual Functions in Eyes With Retinitis Pigmentosa N/A
Active, not recruiting NCT01680510 - The Effect of Oral Administration of 9-cis β Carotene Rich Powder of the Alga Dunaliella Bardawil Phase 1/Phase 2