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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 June 2015 |
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Main ID: |
NCT02465749 |
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Date of registration:
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22/05/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical Trials of Continuous Oxygen Therapy Combined With Blue Light Deprivation in the Treatment of Retinitis Pigmentosa
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Scientific title:
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Clinical Trials of Continuous Oxygen Therapy Combined With Blue Light Deprivation in the Treatment of Retinitis Pigmentosa |
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Date of first enrolment:
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May 2015 |
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Target sample size:
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404 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02465749 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 0
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Countries of recruitment
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China
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Contacts
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Name:
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Qianying Qao, PHD |
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Address:
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Telephone:
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13751829105/18922103820 |
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Email:
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gaoqy@mail.sysu.edu.cn |
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Affiliation:
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Name:
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Qianying Gao, PHD |
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Address:
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Telephone:
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13751829105/18922103820 |
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Email:
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gaoqy@mail.sysu.edu.cn |
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Affiliation:
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Name:
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Qianying Gao, PHD |
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Address:
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Telephone:
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Email:
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Affiliation:
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State Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center, Sun Yat-sen University |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Retinitis Pigmentosa
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Intervention(s)
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Drug: Vitamin AD sig: 1 tablet/tid
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Drug: Compound thrombosis capsule sig: 1.5g/tid
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Device: blue light-absorbing sunglasses
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Drug: Continuous oxygen
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Drug: Vitamin B sig: 10mg/tid
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Drug: Ginkgo biloba pills sig: 300mg/tid;
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Primary Outcome(s)
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the percentage of patients preserved 80% of the initial visual acuity at 5 years follow-up.
[Time Frame: at 5 years follow-up]
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Secondary Outcome(s)
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Fundus changes of fluorescence fundus angiography
[Time Frame: at 5 years follow-up]
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ERG b-wave mean values
[Time Frame: at 5 years follow-up]
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intra-ocular pressure
[Time Frame: at 1, 2, 3, 4 and 5 years follow-up]
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the mutant genes of retinitis pigmentosa
[Time Frame: at admission]
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Retinal vessel oxygen saturation
[Time Frame: at 5 years follow-up]
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blood pressure
[Time Frame: at 1, 2, 3, 4 and 5 years follow-up]
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Change of visual field
[Time Frame: at 5 years follow-up]
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Finger pulse oxygen saturation
[Time Frame: at 1, 2, 3, 4 and 5 years follow-up]
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Secondary ID(s)
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ZOC20150503
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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