Retinitis Pigmentosa
Conditions
Keywords
Retinitis Pigmentosa, oxygen, blue light
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.
Detailed description
Retinitis pigmentosa (RP) is one of of the major causes of blindness in ocular diseases.Up to now, the etiology of RP remained unclear, and there are no effective therapeutic methods. Several studies had showed that the retina of RP may be anoxic, and oxygen therapy, such as hyperbaric oxygen (hyperbaric oxygen, HBO) treatment, had shown a definite effect on RP. The investigators' previous researches also found that the retinal vessel oxygen saturation in patients with RP who were older than 40 years were significantly lower than normal controls, suggesting that oxygen may play an important role in the development of RP. Besides, many studies have revealed that blue light could damage retina pigment epithelium cells and photoreceptor cell specially. Therefore, investigators will combine continuous oxygen therapy and blue light deprivation therapy in the treatment for RP in this study, in order to find a new strategy of treatment for RP.
Interventions
Continuous oxygen intake at a concentration of 93±3%, 3L/min flow-rate, 2h/bid, five days a week;
DEVICEblue light-absorbing sunglasses
Wearing blue light-absorbing sunglasses at daily time;
DRUGCompound thrombosis capsule sig: 1.5g/tid
Compound thrombosis capsule sig: 1.5g/tid
DRUGGinkgo biloba pills sig: 300mg/tid;
Ginkgo biloba pills sig: 300mg/tid;
DRUGVitamin B sig: 10mg/tid
Vitamin B sig: 10mg/tid
DRUGVitamin AD sig: 1 tablet/tid
Vitamin AD sig: 1 tablet/tid
Sponsors
Zhujiang Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou Jeeyor Medical Research Co.,Ltd.
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. 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) 2. Age range from 18 to 60 years old, sex unlimited 3. Able to adhere to treatment for more than 12 months 4. Willing to participate in this trial, and sign the informed consent
Exclusion criteria
1. Serious opacity of cornea, lens or vitreous body which can't have clear fundus examination 2. 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 3. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the percentage of patients preserved 80% of the initial visual acuity at 5 years follow-up. | at 5 years follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of visual field | at 5 years follow-up | visual field |
| Fundus changes of fluorescence fundus angiography | at 5 years follow-up | — |
| Retinal vessel oxygen saturation | at 5 years follow-up | Retinal Oximetry |
| ERG b-wave mean values | at 5 years follow-up | — |
| blood pressure | at 1, 2, 3, 4 and 5 years follow-up | — |
| Finger pulse oxygen saturation | at 1, 2, 3, 4 and 5 years follow-up | Finger pulse oximetry |
| the mutant genes of retinitis pigmentosa | at admission | gene screening |
| intra-ocular pressure | at 1, 2, 3, 4 and 5 years follow-up | — |
Countries
China
Contacts
Primary ContactQianying Gao, PHD
Outcome results
None listed