An Early Phase 1 interventional study of Continuous oxygen and blue light-absorbing sunglasses in Retinitis Pigmentosa, sponsored by Sun Yat-sen University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-06-08.
Sponsored by Sun Yat-sen University · Early Phase 1, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Continuous oxygen intake and routine drug treatment .
Drug: Continuous oxygen · 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
Wearing blue light-absorbing sunglasses at daily time and routine drug treatment
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
Continuous oxygen intake , Wearing blue light-absorbing sunglasses at daily time and routine drug treatment
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
Routine drug treatment
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
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
the percentage of patients preserved 80% of the initial visual acuity at 5 years follow-up.
Time frame: at 5 years follow-up
ERG b-wave mean values
Time frame: at 5 years follow-up
Change of visual field
visual field
Time frame: at 5 years follow-up
Fundus changes of fluorescence fundus angiography
Time frame: at 5 years follow-up
Retinal vessel oxygen saturation
Retinal Oximetry
Time frame: at 5 years follow-up
intra-ocular pressure
Time frame: at 1, 2, 3, 4 and 5 years follow-up
blood pressure
Time frame: at 1, 2, 3, 4 and 5 years follow-up
Finger pulse oxygen saturation
Finger pulse oximetry
Time frame: at 1, 2, 3, 4 and 5 years follow-up
the mutant genes of retinitis pigmentosa
gene screening
Time frame: at admission
This study is not yet recruiting, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Sun Yat-sen University