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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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ChiCTR |
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Last refreshed on:
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13 February 2023 |
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Main ID: |
ChiCTR2200055625 |
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Date of registration:
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2022-01-15 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Clinical study on the safety and efficacy of human embryonic stem cell-derived retinal pigment epithelial cells transplantation for the treatment of macular hole of high myopia
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Scientific title:
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Clinical study on the safety and efficacy of human embryonic stem cell-derived retinal pigment epithelial cells transplantation for the treatment of macular hole of high myopia |
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Date of first enrolment:
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2022-01-15 |
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Target sample size:
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experimental group:12; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=149382 |
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Study type:
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Interventional study |
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Study design:
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Single arm
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Phase:
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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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Fang Wang
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Address:
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29 Gaotanyan Main Street, Shapingba District, Chongqing
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Telephone:
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+86 18375722981 |
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Email:
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659919036@qq.com |
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Affiliation:
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Chongqing Southwest Hospital Ophthalmology Department |
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Name:
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Yong Liu
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Address:
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29 Gaotanyan Main Street, Shapingba District, Chongqing
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Telephone:
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+86 13983732105 |
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Email:
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liuyy99@163.com |
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Affiliation:
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Chongqing Southwest Hospital Ophthalmology Department |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Volunteer as the subject, and the patient signs the informed consent;
2. Aged between 18 and 65 years, regardless of gender;
3. OCT examination confirmed the diagnosis of idiopathic macular hole;
4. Patients with large aperture (horizontal distance at the narrowest part of the hole > 700 µm) or patients with a long course of disease (duration >= 6 months) or those with previous retinal detachment repositioning or vitreous surgery.
Exclusion criteria: 1. Patients with optic neuropathy, corneal disease, glaucoma, uveitis and other vitreoretinal diseases;
2. Combined with severe cardiovascular, liver, kidney and hematopoietic system and other primary diseases, mental illness;
3. Systemic or local use of other drugs that affect the evaluation of efficacy, such as glucocorticoids;
4. Pregnant and lactating women;
5. Those who have participated in other clinical trials in the past three months.
Age minimum:
18
Age maximum:
65
Gender:
Both
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Health Condition(s) or Problem(s) studied
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High myopia macular hole
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Intervention(s)
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experimental group:Retinal pigment epithelial cells are transplanted into the macular hole area;
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Primary Outcome(s)
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Best corrected visual acuity;Intraocular Pressure;Fundus Photography;Spectral Domain Opticalcoherence Tomography, SD-OCT;
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Source(s) of Monetary Support
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2020 Military Subject (20QNPY027)
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Ethics review
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Status: Approved
Approval date: 17/06/2021
Contact:
Qing Mao
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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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