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

Amblyopia Clinical Trial

— VRTA  

Official title:

A Phase 3 Randomized, Single-blind, Multicenter, Clinical Control Study to Evaluate the Efficacy and Safety of Caterna Virtual Reality Facilitating Treatment Patients With Amblyopia in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04238065
• Other study ID #: GuangzhouShijingMS
• Status: Recruiting
• Phase: N/A
• Start date: September 4, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2020
• Source: Guangzhou Shijing Medical Software
• Contact: Jenny Qiu, MD
• Phone: +8618510386815
• Email: qiukk[@]topeye.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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 and Pediatric Ophthalmology Experts "Consensus of Amblyopia Diagnosis " (2011) as the standard to be diagnosed as amblyopia with abnormal vision than that of age-based norms, that is, caused by abnormal visual development due to strabismus, uncorrected refractive error or form deprivation, the best corrected vision acuity of single eye or both eyes below age-based norms; Or 2 eyes' vision acuity difference larger than 2 lines or more. The normal minimum limit of vision acuity for children of different ages are as the followings: The normal minimum limit of vision acuity for children aged 4 to 5 years is 0.5 (decimal vision acuity); And the normal minimum limit of vision 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 an informed consent form; And the subject can cooperate with the whole treatment and related eye examinations? -

Exclusion Criteria:

1. Subjects suffered from tumors, heart disease, hypertension (blood pressure top limitation of children aged 4 to 6 years: 110/70 mmHg, blood pressure top limitation of 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 eyelashes and 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, trauma and other significant vision related lesions;

7. Subject received a masking therapy or a treatment instrument for amblyopia treatment before 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 the patient should not participate in other conditions, such as suffering from a certain severe heart, liver or kidney disease.

Related Conditions & MeSH terms

• Amblyopia

Intervention

Device:
• Caterna Virtual Reality
Vivid interactive games of perceptual learning content, with artificial intelligent sound and scores to feedback vision and actions results, which can be connected to the supervision of cellphone software"Wechat" to upload vision acuity and choose 2 eyes' video output automaticly.
• Spectacles(Best optical corrected distance vision)
Each eye has best corrected vision spectacles with best corrected optical lens.
• Patch
2 hours patch to the non-amblyopia eye if the other amblyopia eye is mild or moderate amblyopia; 6 hours patch to the non-amblyopia eye if the other amblyopia eye is severe abmlyopia

Locations

Country	Name	City	State
China	the first affiliated hospital of Beijing University	Beijing	Beijing
China	Guangzhou Shijing Medical Software Co., Ltd.	Guangzhou	Guangdong
China	Zhongshan Ophthalmic center, Sun Yat-sen University	Guanzhou	Guangdong
China	The first affiliated hospital of Nanjing University	Nanjing	Jiangsu

Sponsors (4)

Lead Sponsor	Collaborator
Guangzhou Shijing Medical Software	The First Affiliated Hospital of Beijing University, The First Affiliated Hospital with Nanjing Medical University, Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (6)

He MG. [The quality of epidemiological research on pediatric refractive error and amblyopia in China needs to be improved]. Zhonghua Yan Ke Za Zhi. 2017 Jan 11;53(1):3-6. doi: 10.3760/cma.j.issn.0412-4081.2017.01.002. Review. Chinese. — View Citation

Holmes JM, Kraker RT, Beck RW, Birch EE, Cotter SA, Everett DF, Hertle RW, Quinn GE, Repka MX, Scheiman MM, Wallace DK; Pediatric Eye Disease Investigator Group. A randomized trial of prescribed patching regimens for treatment of severe amblyopia in child — View Citation

Jin H, Yi JL, Xie H, Xiao F, Wang WJ, Shu XM, Xu YL, Chen SL, Ye WX. [A study on visual development among preschool children]. Zhonghua Yan Ke Za Zhi. 2011 Dec;47(12):1102-6. Chinese. — View Citation

Repka MX, Beck RW, Holmes JM, Birch EE, Chandler DL, Cotter SA, Hertle RW, Kraker RT, Moke PS, Quinn GE, Scheiman MM; Pediatric Eye Disease Investigator Group. A randomized trial of patching regimens for treatment of moderate amblyopia in children. Arch O — View Citation

Scheiman MM, Hertle RW, Beck RW, Edwards AR, Birch E, Cotter SA, Crouch ER Jr, Cruz OA, Davitt BV, Donahue S, Holmes JM, Lyon DW, Repka MX, Sala NA, Silbert DI, Suh DW, Tamkins SM; Pediatric Eye Disease Investigator Group. Randomized trial of treatment of — View Citation

Yazdani N, Sadeghi R, Momeni-Moghaddam H, Zarifmahmoudi L, Ehsaei A, Barrett BT. Part-time versus full-time occlusion therapy for treatment of amblyopia: A meta-analysis. J Curr Ophthalmol. 2017 Mar 6;29(2):76-84. doi: 10.1016/j.joco.2017.01.006. eCollect — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Severe Adverse Event Number	Total number of Severe Adverse Event	13 weeks
Primary	Effectiveness of amblyopia treatment with VR	General Effectiveness=Number of both cured eyes and effective eyes from total number×100%	13 weeks
Secondary	Effectiveness of 8 weeks' VR amblyopia treatment	General Effectiveness=Number of both cured eyes and effective eyes from total number×100%	8 weeks
Secondary	Effectiveness of 4 weeks' VR amblyopia treatment	General Effectiveness=Number of both cured eyes and effective eyes from total number×100%	4 weeks
Secondary	Stereopsis: distance and near, respectively	Ratio of stereopsis perception=(Number of stereopsis perception /Total number)*100%	13 weeks
Secondary	Contrast sensitivity function(CSF)	Difference between those final CSF and baseline CSF	13 weeks