retinitis pigmentosa
Conditions
Interventions
Use of glasses that emit violet light
Sponsors
Ban Norimitsu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients diagnosed with retinitis pigmentosa (RP) according to the "Retinitis Pigmentosa Treatment Guidelines (2016)" , and classified as Grade I and II in the severity classification (*) within these guidelines [corresponding to "No vision impairment (decimal visual acuity of 0.5 or higher)" under the World Health Organization (WHO) International Statistical Classification of Diseases and Related Health Problems, 11th Revision (ICD-11)]. *The severity classification is as follows; Grade I: Corrected visual acuity of 0.7 or higher, with no visual field constriction. Grade II: Corrected visual acuity of 0.7 or higher, with visual field constriction. Grade III: Corrected visual acuity less than 0.7, but 0.2 or higher. Grade IV: Corrected visual acuity less than 0.2. 2) Genetic subtype of RP: Not specified. 3) Age and Gender: Male and female subjects aged 18 years or older at the time of informed consent. 4) Inpatient or outpatient status: Not specified. 5) Patients who can wear the test device for 3 hours a day (tolerance range: -30 minutes, +0 minutes) between 8:00 and 19:00 throughout the observation period of this study. 6) Patients with no prior treatment history with Voretigene neparvovec. 7) Patients whose dosage of medications used for retinitis pigmentosa (e.g., vitamin A, Helenien preparations, etc.) has not changed during the 6 months prior to obtaining informed consent. 8) Patients who have provided written informed consent to participate in this study (consent from a legally authorized representative is not permitted). The written informed consent shall include agreement to the use of any available medical information related to retinitis pigmentosa (RP) prior to the date of consent as reference data for this study, if such information is available at the study site.
Exclusion criteria
Exclusion criteria: 1) Patients who have been diagnosed with hereditary retinal degenerative diseases other than retinitis pigmentosa (RP), macular dystrophy, cone dystrophy, or acquired retinal degeneration. 2) Patients with ocular disorders other than RP that may affect the assessments in this study, such as macular edema (associated with RP or other non-hereditary retinal diseases), macular degeneration [age-related macular degeneration (exudative or atrophic) or other non-hereditary retinal diseases], significant opacities of the ocular media, or systemic diseases (e.g., oculocutaneous albinism, dementia, severe cardiac, pulmonary, hepatic, or gastrointestinal disorders). 3) Patients with a history of epilepsy or seizure disorders, or those currently diagnosed with such conditions. 4) Patients who have previously undergone cataract surgery or vitreoretinal surgery for macular disease, or those who are scheduled to undergo such eye surgery during the study period. 5) Patients who are using medications or undergoing therapies that may affect retinal function (e.g., vitamin E, hydroxychloroquine, phenothiazine antipsychotics such as chlorpromazine, isopropyl unoprostone, or electrical stimulation therapy). 6) Patients with a history or suspected history of photosensitivity. 7) Patients who have participated in another clinical study or clinical trial prior to obtaining informed consent, where the effect of the intervention has not yet disappeared, or patients who are scheduled to participate in another clinical study/trial during the study period. 8) Patients deemed inappropriate for participation in this study by the principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of cases in which RP-related symptoms or findings were observed among adverse events, and a causal relationship with violet light (VL) could not be excluded. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Incidence, frequency, severity, and causal relationship of adverse events and medical conditions determined to be related to the investigational device (i.e., violet light [VL]-emitting glasses), occurring after the initiation of VL exposure. 2)Incidence of device malfunctions. | — |
Contacts
Public ContactNorimitsu Ban
Keio University Hospital
Outcome results
None listed