A Clinical Trial of Caterna Virtual Reality Facilitating Treatment in Children With Amblyopia

Last updated: February 3, 2020
Sponsor: Guangzhou Shijing Medical Software
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vision Loss

Eye Disorders/infections

Eye Disease

Treatment

N/A

Clinical Study ID

NCT04238065
GuangzhouShijingMS
  • Ages 4-12
  • All Genders

Study Summary

It aims to find the effectiveness and the safety of Virtual Reality (Caterna, DOBOSO, item code: SJ-VRS2018) to facilitate amblyopia treatment combining spectacles and occlusion. And it also aims to test whether amblyopia treatment outcomes with spectacles, occlusion and VR are significant better than those without VR, but with spectacles and occlusion.

The experiment arm is designed to use the Caterna VR to treat amblyopia for total consistent 13 weeks, 3 times per week, while the control arm is not.

Both arms are best optical correction and with patch the non-amblyopia eye 2 hours or 6 hours per day.

All eyes are followed up for total 13 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Ages from 4~12 years old (including 4 years or 12 years old);

  2. 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).

  3. 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:

  1. 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;

  2. The subject has implanted electronic devices, such as pacemakers, etc.

  3. The subject had or has a mental illness;

  4. Any eye of the subject due to keratitis, conjunctivitis, internal turning eyelashesand other diseases leading to photophobia or continuing tears;

  5. Subject suffered from vertigo, acrophobia or traumatic brain lesions;

  6. The subject's eye has congenital glaucoma, congenital ptosis, dacryocystitis, traumaand other significant vision related lesions;

  7. Subject received a masking therapy or a treatment instrument for amblyopia treatmentbefore joining this study;

  8. The subject participated in other clinical trials before joining this study;

  9. 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

Total Participants: 300
Study Start date:
September 04, 2019
Estimated Completion Date:
December 31, 2021

Study Description

The amblyopia eye will see the video content from Caterna VR a little bit earlier (12 ms) than the other non-amblyopia eye.

Also, the illumination and contrast are both adjusted to balance 2 eyes' clarity.

One VR treatment sequence is 30 minutes with 5 minutes break in the middle.

Connect with a study center

  • the first affiliated hospital of Beijing University

    Beijing, Beijing 100045
    China

    Active - Recruiting

  • Guangzhou Shijing Medical Software Co., Ltd.

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • Zhongshan Ophthalmic center, Sun Yat-sen University

    Guanzhou, Guangdong 510000
    China

    Active - Recruiting

  • The first affiliated hospital of Nanjing University

    Nanjing, Jiangsu 210029
    China

    Active - Recruiting

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