Clinical Trials of Continuous Oxygen Therapy Combined With Blue Light Deprivation in the Treatment of Retinitis Pigmentosa
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 404
- 试验地点
- 1
- 主要终点
- the percentage of patients preserved 80% of the initial visual acuity at 5 years follow-up.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Blue Light Deprivation
Wearing blue light-absorbing sunglasses at daily time and routine drug treatment
干预措施: blue light-absorbing sunglasses (Device)
Continuous Oxygen
Continuous oxygen intake and routine drug treatment .
干预措施: Continuous oxygen (Drug)
Continuous Oxygen Therapy Combined With Blue Light Deprivation
Continuous oxygen intake , Wearing blue light-absorbing sunglasses at daily time and routine drug treatment
干预措施: Continuous oxygen (Drug)
Continuous Oxygen Therapy Combined With Blue Light Deprivation
Continuous oxygen intake , Wearing blue light-absorbing sunglasses at daily time and routine drug treatment
干预措施: blue light-absorbing sunglasses (Device)
结局指标
主要结局
the percentage of patients preserved 80% of the initial visual acuity at 5 years follow-up.
时间窗: at 5 years follow-up
次要结局
- ERG b-wave mean values(at 5 years follow-up)
- Change of visual field(at 5 years follow-up)
- Retinal vessel oxygen saturation(at 5 years follow-up)
- Fundus changes of fluorescence fundus angiography(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(at 1, 2, 3, 4 and 5 years follow-up)
- the mutant genes of retinitis pigmentosa(at admission)
研究者
Qianying Gao
professor
Sun Yat-sen University