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

Sun Yat-sen University

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Retinitis Pigmentosa

Treatments: Drug: Continuous oxygen; Drug: Vitamin B sig: 10mg/tid; Drug: Compound thrombosis capsule sig: 1.5g/tid; Device: blue light-absorbing sunglasses; Drug: Ginkgo biloba pills sig: 300mg/tid;; Drug: Vitamin AD sig: 1 tablet/tid

Study type: Interventional

Funder types: Other

Identifiers

NCT02465749

ZOC20150503

Details and patient eligibility

About

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.

Full 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.

Enrollment: 404 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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404 participants in 4 patient groups

Continuous Oxygen

Experimental group

Description:

Continuous oxygen intake and routine drug treatment .

Treatment:

Drug: Continuous oxygen

Drug: Vitamin AD sig: 1 tablet/tid

Drug: Ginkgo biloba pills sig: 300mg/tid;

Drug: Vitamin B sig: 10mg/tid

Drug: Compound thrombosis capsule sig: 1.5g/tid

Blue Light Deprivation

Experimental group

Description:

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

Treatment:

Drug: Vitamin AD sig: 1 tablet/tid

Drug: Ginkgo biloba pills sig: 300mg/tid;

Drug: Vitamin B sig: 10mg/tid

Drug: Compound thrombosis capsule sig: 1.5g/tid

Device: blue light-absorbing sunglasses

Continuous Oxygen Therapy Combined With Blue Light Deprivation

Experimental group

Description:

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

Treatment:

Drug: Continuous oxygen

Drug: Vitamin AD sig: 1 tablet/tid

Drug: Ginkgo biloba pills sig: 300mg/tid;

Drug: Vitamin B sig: 10mg/tid

Drug: Compound thrombosis capsule sig: 1.5g/tid

Device: blue light-absorbing sunglasses

control

Other group

Description:

Routine drug treatment

Treatment:

Drug: Vitamin AD sig: 1 tablet/tid

Drug: Ginkgo biloba pills sig: 300mg/tid;

Drug: Vitamin B sig: 10mg/tid

Drug: Compound thrombosis capsule sig: 1.5g/tid