Trial | NCT02465749  Report issue

Official Title

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

  • Phase

    Early Phase 1

  • Study Type

    Interventional

  • Status

    Not yet recruiting

  • Intervention/Treatment

    nicotinamide oxygen yinhsing vitamin a ...

  • Study Participants

    404
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.
Study Started
May 31
2015
Primary Completion
Jun 30
2025
Anticipated
Study Completion
Jun 30
2025
Anticipated
Last Update
Jun 08
2015
Estimate

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

Continuous Oxygen Experimental

Continuous oxygen intake and routine drug treatment .

Blue Light Deprivation Experimental

Wearing blue light-absorbing sunglasses at daily time and routine drug treatment

Continuous Oxygen Therapy Combined With Blue Light Deprivation Experimental

Continuous oxygen intake , Wearing blue light-absorbing sunglasses at daily time and routine drug treatment

control Other

Routine drug treatment

Criteria 

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
No Results Posted