Clinical trial NCT02465749: Clinical Trials of Continuous Oxygen Therapy Combined With Blue Light Deprivation in the Treatment of Retinitis Pigmentosa
Official title: Clinical Trials of Continuous Oxygen Therapy Combined With Blue Light Deprivation in the Treatment of Retinitis Pigmentosa
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Retinitis Pigmentosa
Keywords: Retinitis Pigmentosa
oxygen
blue light
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Zhujiang Hospital
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Guangzhou Jeeyor Medical Research Co.,Ltd.
First posted: 2015-06-08
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

1. 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)
2. Age range from 18 to 60 years old, sex unlimited
3. Able to adhere to treatment for more than 12 months
4. Willing to participate in this trial, and sign the informed consent

Exclusion Criteria:

1. Serious opacity of cornea, lens or vitreous body which can't have clear fundus examination
2. 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
3. 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

Primary outcomes:
measure: the percentage of patients preserved 80% of the initial visual acuity at 5 years follow-up.
timeFrame: at 5 years follow-up
Secondary outcomes:
measure: ERG b-wave mean values
timeFrame: at 5 years follow-up
measure: Change of visual field
timeFrame: at 5 years follow-up
measure: Fundus changes of fluorescence fundus angiography
timeFrame: at 5 years follow-up
measure: Retinal vessel oxygen saturation
timeFrame: at 5 years follow-up
measure: intra-ocular pressure
timeFrame: at 1, 2, 3, 4 and 5 years follow-up
measure: blood pressure
timeFrame: at 1, 2, 3, 4 and 5 years follow-up
measure: Finger pulse oxygen saturation
timeFrame: at 1, 2, 3, 4 and 5 years follow-up
measure: the mutant genes of retinitis pigmentosa
timeFrame: at admission
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: State Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: State Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Qianying Gao, PHD
role: PRINCIPAL_INVESTIGATOR
References: