NCT02465749

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 404 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Retinitis Pigmentosa

Interventions

Type	Name	Description
DRUG	Continuous oxygen	Continuous oxygen intake at a concentration of 93±3%, 3L/min flow-rate, 2h/bid, five days a week;
DEVICE	blue light-absorbing sunglasses	Wearing blue light-absorbing sunglasses at daily time;
DRUG	Compound thrombosis capsule sig: 1.5g/tid	Compound thrombosis capsule sig: 1.5g/tid
DRUG	Ginkgo biloba pills sig: 300mg/tid;	Ginkgo biloba pills sig: 300mg/tid;
DRUG	Vitamin B sig: 10mg/tid	Vitamin B sig: 10mg/tid
DRUG	Vitamin AD sig: 1 tablet/tid	Vitamin AD sig: 1 tablet/tid

Timeline

• Start date: 2015-05-01
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2015-06-08
• Last updated: 2015-06-08

Locations

1 site across 1 country: China