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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Sun Yat-sen University

Current Primary Outcome: the percentage of patients preserved 80% of the initial visual acuity at 5 years follow-up. [ Time Frame: at 5 years follow-up ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • ERG b-wave mean values [ Time Frame: at 5 years follow-up ]
  • Change of visual field [ Time Frame: at 5 years follow-up ]
    visual field
  • Fundus changes of fluorescence fundus angiography [ Time Frame: at 5 years follow-up ]
  • Retinal vessel oxygen saturation [ Time Frame: at 5 years follow-up ]
    Retinal Oximetry
  • 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 [ Time Frame: at 1, 2, 3, 4 and 5 years follow-up ]
    Finger pulse oximetry
  • the mutant genes of retinitis pigmentosa [ Time Frame: at admission ]
    gene screening


Original Secondary Outcome: Same as current

Information By: Sun Yat-sen University

Dates:
Date Received: May 22, 2015
Date Started: May 2015
Date Completion: June 2025
Last Updated: June 4, 2015
Last Verified: June 2015