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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

404 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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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

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Retinitis Pigmentosa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Continuous Oxygen

Continuous oxygen intake and routine drug treatment .

Group Type EXPERIMENTAL

Continuous oxygen

Intervention Type DRUG

Continuous oxygen intake at a concentration of 93±3%, 3L/min flow-rate, 2h/bid, five days a week;

Compound thrombosis capsule sig: 1.5g/tid

Intervention Type DRUG

Compound thrombosis capsule sig: 1.5g/tid

Ginkgo biloba pills sig: 300mg/tid;

Intervention Type DRUG

Ginkgo biloba pills sig: 300mg/tid;

Vitamin B sig: 10mg/tid

Intervention Type DRUG

Vitamin B sig: 10mg/tid

Vitamin AD sig: 1 tablet/tid

Intervention Type DRUG

Vitamin AD sig: 1 tablet/tid

Blue Light Deprivation

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

Group Type EXPERIMENTAL

blue light-absorbing sunglasses

Intervention Type DEVICE

Wearing blue light-absorbing sunglasses at daily time;

Compound thrombosis capsule sig: 1.5g/tid

Intervention Type DRUG

Compound thrombosis capsule sig: 1.5g/tid

Ginkgo biloba pills sig: 300mg/tid;

Intervention Type DRUG

Ginkgo biloba pills sig: 300mg/tid;

Vitamin B sig: 10mg/tid

Intervention Type DRUG

Vitamin B sig: 10mg/tid

Vitamin AD sig: 1 tablet/tid

Intervention Type DRUG

Vitamin AD sig: 1 tablet/tid

Continuous Oxygen Therapy Combined With Blue Light Deprivation

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

Group Type EXPERIMENTAL

Continuous oxygen

Intervention Type DRUG

Continuous oxygen intake at a concentration of 93±3%, 3L/min flow-rate, 2h/bid, five days a week;

blue light-absorbing sunglasses

Intervention Type DEVICE

Wearing blue light-absorbing sunglasses at daily time;

Compound thrombosis capsule sig: 1.5g/tid

Intervention Type DRUG

Compound thrombosis capsule sig: 1.5g/tid

Ginkgo biloba pills sig: 300mg/tid;

Intervention Type DRUG

Ginkgo biloba pills sig: 300mg/tid;

Vitamin B sig: 10mg/tid

Intervention Type DRUG

Vitamin B sig: 10mg/tid

Vitamin AD sig: 1 tablet/tid

Intervention Type DRUG

Vitamin AD sig: 1 tablet/tid

control

Routine drug treatment

Group Type OTHER

Compound thrombosis capsule sig: 1.5g/tid

Intervention Type DRUG

Compound thrombosis capsule sig: 1.5g/tid

Ginkgo biloba pills sig: 300mg/tid;

Intervention Type DRUG

Ginkgo biloba pills sig: 300mg/tid;

Vitamin B sig: 10mg/tid

Intervention Type DRUG

Vitamin B sig: 10mg/tid

Vitamin AD sig: 1 tablet/tid

Intervention Type DRUG

Vitamin AD sig: 1 tablet/tid

Interventions

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Continuous oxygen

Continuous oxygen intake at a concentration of 93±3%, 3L/min flow-rate, 2h/bid, five days a week;

Intervention Type DRUG

blue light-absorbing sunglasses

Wearing blue light-absorbing sunglasses at daily time;

Intervention Type DEVICE

Compound thrombosis capsule sig: 1.5g/tid

Intervention Type DRUG

Ginkgo biloba pills sig: 300mg/tid;

Intervention Type DRUG

Vitamin B sig: 10mg/tid

Intervention Type DRUG

Vitamin AD sig: 1 tablet/tid

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No