The natural history in individuals with severe retinitis pigmentosa (RP) is variable and there remains an unmet need to better understand disease progression in this population. The goal of this study is to determine which visual assessments individuals with RP and low visual acuity can reliably perform and to evaluate the annual decline of visual function in severe RP.
This is a 12-month, single-center, prospective observational study in adults with RP. Approximately 12 subjects will be enrolled into the Observation Period. The primary objective of this study is to determine which visual assessments RP subjects with low visual acuity can reliably perform. Other objectives are 1) to determine which visual assessments are most sensitive to annual change in RP subjects with low visual acuity, 2) to evaluate adverse events, 3) to evaluate the safety and tolerability of study assessment procedures, and 4) to evaluate the subject's experience in this study, relevance of visual assessments and patient-reported outcome measures, and perception of improvement in visual function.
Study Type
OBSERVATIONAL
Enrollment
12
Mass Eye and Ear
Boston, Massachusetts, United States
Reliability (test-retest variability within subjects)
Reliability (test-retest variability within subjects) on: * Total visual area (degrees squared) on kinetic perimetry using III-4e stimulus (excluding temporal islands) (Time frame: 12 months) * Early Treatment of Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) Log of Minimum Angle of Resolution (LogMAR) equivalent (or Low Vision Test, as applicable) (Time frame: 12 months) * Retinal light sensitivity on Full-field Stimulus Threshold test (Time frame: 12 months) * Retinal sensitivity and fixation stability on microperimetry (Time frame: 12 months)
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.