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

Early Phase 1UnknownNCT02465749

Sun Yat-sen University404 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

404

Conditions

Retinitis Pigmentosa

Interventions

Continuous oxygenDRUG

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

blue light-absorbing sunglassesDEVICE

Wearing blue light-absorbing sunglasses at daily time;

Compound thrombosis capsule sig: 1.5g/tidDRUG

Compound thrombosis capsule sig: 1.5g/tid

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

State Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China