Clinical Trials of Continuous Oxygen Therapy Combined With Blue Light Deprivation in the Treatment of Retinitis Pigmentosa
1 other identifier
interventional
404
1 country
1
Brief Summary
The purpose of this study is to investigate the role of continuous oxygen therapy combined with blue light deprivation in prevention and control of retinitis pigmentosa, in order to find a new strategy of treatment for retinitis pigmentosa.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started May 2015
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 22, 2015
CompletedFirst Posted
Study publicly available on registry
June 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedJune 8, 2015
June 1, 2015
10.1 years
May 22, 2015
June 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the percentage of patients preserved 80% of the initial visual acuity at 5 years follow-up.
at 5 years follow-up
Secondary Outcomes (8)
ERG b-wave mean values
at 5 years follow-up
Change of visual field
at 5 years follow-up
Fundus changes of fluorescence fundus angiography
at 5 years follow-up
Retinal vessel oxygen saturation
at 5 years follow-up
intra-ocular pressure
at 1, 2, 3, 4 and 5 years follow-up
- +3 more secondary outcomes
Study Arms (4)
Continuous Oxygen
EXPERIMENTALContinuous oxygen intake and routine drug treatment .
Blue Light Deprivation
EXPERIMENTALWearing blue light-absorbing sunglasses at daily time and routine drug treatment
Continuous Oxygen Therapy Combined With Blue Light Deprivation
EXPERIMENTALContinuous oxygen intake , Wearing blue light-absorbing sunglasses at daily time and routine drug treatment
control
OTHERRoutine drug treatment
Interventions
Continuous oxygen intake at a concentration of 93±3%, 3L/min flow-rate, 2h/bid, five days a week;
Wearing blue light-absorbing sunglasses at daily time;
Compound thrombosis capsule sig: 1.5g/tid
Ginkgo biloba pills sig: 300mg/tid;
Vitamin B sig: 10mg/tid
Vitamin AD sig: 1 tablet/tid
Eligibility Criteria
You may qualify if:
- Severe patients with RP who meet the following criteria: (1) the EDTRS visual acuity of the good eye \< 0.3 (low vision);(2) the radius of central visual field\< 10 °(low vision)
- Age range from 18 to 60 years old, sex unlimited
- Able to adhere to treatment for more than 12 months
- Willing to participate in this trial, and sign the informed consent
You may not qualify if:
- Serious opacity of cornea, lens or vitreous body which can't have clear fundus examination
- Patients with severe systemic diseases who was unable to tolerate the examinations, such as heart failure, respiratory failure, sepsis, severe anemia, kidney disease, history of eye surgery and so on
- Patients who was unable to tolerate oxygen treatment, such as severe pulmonary edema, deformity of the respiratory tract, respiratory tract infection, tuberculosis, patients with pregnancy, and so on
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sun Yat-sen Universitylead
- Zhujiang Hospitalcollaborator
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Universitycollaborator
- Guangzhou Jeeyor Medical Research Co.,Ltd.collaborator
Study Sites (1)
State Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qianying Gao, PHD
State Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center, Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
May 22, 2015
First Posted
June 8, 2015
Study Start
May 1, 2015
Primary Completion
June 1, 2025
Study Completion
June 1, 2025
Last Updated
June 8, 2015
Record last verified: 2015-06