Phase
Condition
Vision Loss
Eye Disorders/infections
Eye Disease
Treatment
N/AClinical Study ID
Ages 4-12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Ages from 4~12 years old (including 4 years or 12 years old);
According to the Chinese Medical Association Ophthalmology branch: Strabismus andPediatric Ophthalmology Experts "Consensus of Amblyopia Diagnosis " (2011) as thestandard to be diagnosed as amblyopia with abnormal vision than that of age-basednorms, that is, caused by abnormal visual development due to strabismus, uncorrectedrefractive error or form deprivation, the best corrected vision acuity of single eyeor both eyes below age-based norms; Or 2 eyes' vision acuity difference larger than 2lines or more. The normal minimum limit of vision acuity for children of differentages are as the followings: The normal minimum limit of vision acuity for childrenaged 4 to 5 years is 0.5 (decimal vision acuity); And the normal minimum limit ofvision acuity for children aged 6 and over is 0.7(decimal vision acuity).
The subject's supervision is fully understand the purpose of the trial and sign aninformed consent form; And the subject can cooperate with the whole treatment andrelated eye examinations。 -
Exclusion
Exclusion Criteria:
Subjects suffered from tumors, heart disease, hypertension (blood pressure toplimitation of children aged 4 to 6 years: 110/70 mmHg, blood pressure top limitationof children aged 7 to 12 years: 120/80 mmHg), or epilepsy;
The subject has implanted electronic devices, such as pacemakers, etc.
The subject had or has a mental illness;
Any eye of the subject due to keratitis, conjunctivitis, internal turning eyelashesand other diseases leading to photophobia or continuing tears;
Subject suffered from vertigo, acrophobia or traumatic brain lesions;
The subject's eye has congenital glaucoma, congenital ptosis, dacryocystitis, traumaand other significant vision related lesions;
Subject received a masking therapy or a treatment instrument for amblyopia treatmentbefore joining this study;
The subject participated in other clinical trials before joining this study;
For safety reasons or for the benefit of patients, the researchers believe that thepatient should not participate in other conditions, such as suffering from a certainsevere heart, liver or kidney disease.
Study Design
Study Description
Connect with a study center
the first affiliated hospital of Beijing University
Beijing, Beijing 100045
ChinaActive - Recruiting
Guangzhou Shijing Medical Software Co., Ltd.
Guangzhou, Guangdong 510000
ChinaSite Not Available
Zhongshan Ophthalmic center, Sun Yat-sen University
Guanzhou, Guangdong 510000
ChinaActive - Recruiting
The first affiliated hospital of Nanjing University
Nanjing, Jiangsu 210029
ChinaActive - Recruiting
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