Clinical Trials of Continuous Oxygen Therapy Combined With Blue Light Deprivation in the Treatment of Retinitis Pigmentosa

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Trials of Continuous Oxygen Therapy Combined With Blue Light Deprivation in the Treatment of Retinitis Pigmentosa

Conditions
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Retinitis Pigmentosa

Intervention / Treatment
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* Drug: Continuous oxygen
* Device: blue light-absorbing sunglasses
* Drug: Compound thrombosis capsule sig: 1.5g/tid
* Drug: Ginkgo biloba pills sig: 300mg/tid;
* Drug: Vitamin B sig: 10mg/tid
* Drug: Vitamin AD sig: 1 tablet/tid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous Oxygen<br>Continuous oxygen intake and routine drug treatment . | Drug: Continuous oxygen<br>* Continuous oxygen intake at a concentration of 93±3%, 3L/min flow-rate, 2h/bid, five days a week;<br>Drug: Compound thrombosis capsule sig: 1.5g/tid<br>* Compound thrombosis capsule sig: 1.5g/tid<br>Drug: Ginkgo biloba pills sig: 300mg/tid;<br>* Ginkgo biloba pills sig: 300mg/tid;<br>Drug: Vitamin B sig: 10mg/tid<br>* Vitamin B sig: 10mg/tid<br>Drug: Vitamin AD sig: 1 tablet/tid<br>* Vitamin AD sig: 1 tablet/tid<br>|
| Experimental: Blue Light Deprivation<br>Wearing blue light-absorbing sunglasses at daily time and routine drug treatment | Device: blue light-absorbing sunglasses<br>* Wearing blue light-absorbing sunglasses at daily time;<br>Drug: Compound thrombosis capsule sig: 1.5g/tid<br>* Compound thrombosis capsule sig: 1.5g/tid<br>Drug: Ginkgo biloba pills sig: 300mg/tid;<br>* Ginkgo biloba pills sig: 300mg/tid;<br>Drug: Vitamin B sig: 10mg/tid<br>* Vitamin B sig: 10mg/tid<br>Drug: Vitamin AD sig: 1 tablet/tid<br>* Vitamin AD sig: 1 tablet/tid<br>|
| Experimental: Continuous Oxygen Therapy Combined With Blue Light Deprivation<br>Continuous oxygen intake , Wearing blue light-absorbing sunglasses at daily time and routine drug treatment | Drug: Continuous oxygen<br>* Continuous oxygen intake at a concentration of 93±3%, 3L/min flow-rate, 2h/bid, five days a week;<br>Device: blue light-absorbing sunglasses<br>* Wearing blue light-absorbing sunglasses at daily time;<br>Drug: Compound thrombosis capsule sig: 1.5g/tid<br>* Compound thrombosis capsule sig: 1.5g/tid<br>Drug: Ginkgo biloba pills sig: 300mg/tid;<br>* Ginkgo biloba pills sig: 300mg/tid;<br>Drug: Vitamin B sig: 10mg/tid<br>* Vitamin B sig: 10mg/tid<br>Drug: Vitamin AD sig: 1 tablet/tid<br>* Vitamin AD sig: 1 tablet/tid<br>|
| Other: control<br>Routine drug treatment | Drug: Compound thrombosis capsule sig: 1.5g/tid<br>* Compound thrombosis capsule sig: 1.5g/tid<br>Drug: Ginkgo biloba pills sig: 300mg/tid;<br>* Ginkgo biloba pills sig: 300mg/tid;<br>Drug: Vitamin B sig: 10mg/tid<br>* Vitamin B sig: 10mg/tid<br>Drug: Vitamin AD sig: 1 tablet/tid<br>* Vitamin AD sig: 1 tablet/tid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percentage of patients preserved 80% of the initial visual acuity at 5 years follow-up. |  | at 5 years follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ERG b-wave mean values |  | at 5 years follow-up | 
| Change of visual field | visual field | at 5 years follow-up | 
| Fundus changes of fluorescence fundus angiography |  | at 5 years follow-up | 
| Retinal vessel oxygen saturation | Retinal Oximetry | at 5 years follow-up | 
| intra-ocular pressure |  | at 1, 2, 3, 4 and 5 years follow-up | 
| blood pressure |  | at 1, 2, 3, 4 and 5 years follow-up | 
| Finger pulse oxygen saturation | Finger pulse oximetry | at 1, 2, 3, 4 and 5 years follow-up | 
| the mutant genes of retinitis pigmentosa | gene screening | at admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retinitis Pigmentosa, oxygen, blue light