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

Primary Purpose

Amblyopia

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Caterna Virtual Reality

Spectacles(Best optical corrected distance vision)

Patch

About this trial

This is an interventional treatment trial for Amblyopia focused on measuring Amblyopia; Virtual Reality

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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;
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 eyelashes and 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, trauma and other significant vision related lesions;
Subject received a masking therapy or a treatment instrument for amblyopia treatment before 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 the patient should not participate in other conditions, such as suffering from a certain severe heart, liver or kidney disease.

Sites / Locations

the first affiliated hospital of Beijing UniversityRecruiting
Guangzhou Shijing Medical Software Co., Ltd.
Zhongshan Ophthalmic center, Sun Yat-sen UniversityRecruiting
The first affiliated hospital of Nanjing UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

VR treatment

control

Arm Description

The arm will use the virtual reality headset reproduces dynamic video content with perceptual learning and binocular perception (including stereopsis) that is visually perceived a little bit faster, brighter, and higher contrast to the amblyopia eyes . The each VR therapy length is 30 minutes with 5 minute break after 15 minutes' therapy sequence, 3 times per week, total 13 weeks. All amblyopia eyes are best optical correction or combining patching non-amblyopia eyes if there're more than 2 lines difference best corrected vision acuity.

This arm of amblyopia eyes are all best optical correction or combining patching non-amblyopia eyes if there're more than 2 lines difference best corrected vision acuity. No VR therapy.

Outcomes

Primary Outcome Measures

Effectiveness of amblyopia treatment with VR

General Effectiveness=Number of both cured eyes and effective eyes from total number×100%

Secondary Outcome Measures

Effectiveness of 8 weeks' VR amblyopia treatment

General Effectiveness=Number of both cured eyes and effective eyes from total number×100%

Effectiveness of 4 weeks' VR amblyopia treatment

General Effectiveness=Number of both cured eyes and effective eyes from total number×100%

Stereopsis: distance and near, respectively

Ratio of stereopsis perception=(Number of stereopsis perception /Total number)*100%

Contrast sensitivity function(CSF)

Difference between those final CSF and baseline CSF

Full Information

NCT ID

NCT04238065

First Posted

January 18, 2020

Last Updated

February 3, 2020

Sponsor

Guangzhou Shijing Medical Software

Collaborators

The First Affiliated Hospital with Nanjing Medical University, The First Affiliated Hospital of Beijing University, Zhongshan Ophthalmic Center, Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT04238065

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 4, 2019 (Actual)

Primary Completion Date

December 31, 2020 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Guangzhou Shijing Medical Software

Collaborators

The First Affiliated Hospital with Nanjing Medical University, The First Affiliated Hospital of Beijing University, Zhongshan Ophthalmic Center, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amblyopia

Keywords

Amblyopia; Virtual Reality

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

One arm receive VR treatment while the other arm does not. Both arms get best optical correction and 2 hours (for mild and moderate amblyopia）patch or 6 hours (for severe amblyopia) patch their non-amblyopia eyes.

Masking

Care ProviderInvestigatorOutcomes Assessor

Masking Description

Research centers are used as a stratification factor. The researchers include subjects in the trial group or control group based on randomized envelopes.

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

VR treatment

Arm Type

Experimental

Arm Description

Arm Title

control

Arm Type

Placebo Comparator

Arm Description

This arm of amblyopia eyes are all best optical correction or combining patching non-amblyopia eyes if there're more than 2 lines difference best corrected vision acuity. No VR therapy.

Intervention Type

Device

Intervention Name(s)

Caterna Virtual Reality

Other Intervention Name(s)

SJ-VRS2018, DOBOSO VR, Vision Therapy Software

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Spectacles(Best optical corrected distance vision)

Other Intervention Name(s)

Optical correction

Intervention Description

Each eye has best corrected vision spectacles with best corrected optical lens.

Intervention Type

Device

Intervention Name(s)

Patch

Other Intervention Name(s)

Occlusion

Intervention Description

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

Primary Outcome Measure Information:

Title

Effectiveness of amblyopia treatment with VR

Description

General Effectiveness=Number of both cured eyes and effective eyes from total number×100%

Time Frame

13 weeks

Secondary Outcome Measure Information:

Title

Effectiveness of 8 weeks' VR amblyopia treatment

Description

General Effectiveness=Number of both cured eyes and effective eyes from total number×100%

Time Frame

8 weeks

Title

Effectiveness of 4 weeks' VR amblyopia treatment

Description

General Effectiveness=Number of both cured eyes and effective eyes from total number×100%

Time Frame

4 weeks

Title

Stereopsis: distance and near, respectively

Description

Ratio of stereopsis perception=(Number of stereopsis perception /Total number)*100%

Time Frame

13 weeks

Title

Contrast sensitivity function(CSF)

Description

Difference between those final CSF and baseline CSF

Time Frame

13 weeks

Other Pre-specified Outcome Measures:

Title

Severe Adverse Event Number

Description

Total number of Severe Adverse Event

Time Frame

13 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ages from 4~12 years old (including 4 years or 12 years old）； 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). 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: 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; 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 eyelashes and 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, trauma and other significant vision related lesions; Subject received a masking therapy or a treatment instrument for amblyopia treatment before 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 the patient should not participate in other conditions, such as suffering from a certain severe heart, liver or kidney disease.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jenny Qiu, MD

Phone

+8618510386815

qiukk@topeye.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Taylor Zhu, MS

Phone

+8613060934107

zhuda@topeye.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaohong Liu

Organizational Affiliation

Guangzhou Shijing Medical Software

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Mosheng Zhou

Organizational Affiliation

Guangzhou Shijing Medical Software

Official's Role

Study Chair

Facility Information:

Facility Name

the first affiliated hospital of Beijing University

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100045

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaoqing Li, MD, PhD

Phone

+861083572336

fangfeilee8@126.com

First Name & Middle Initial & Last Name & Degree

Yiwen Cao, MD, PhD

Phone

+8613269978261

ertongyanke@126.com

First Name & Middle Initial & Last Name & Degree

Xiaoqing Li, MD, PhD

First Name & Middle Initial & Last Name & Degree

Jing Wen, MD, PhD

First Name & Middle Initial & Last Name & Degree

Yiwen Cao, MD, PhD

Facility Name

Guangzhou Shijing Medical Software Co., Ltd.

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

Individual Site Status

Active, not recruiting

Facility Name

Zhongshan Ophthalmic center, Sun Yat-sen University

City

Guanzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jianhua Yan, MD, PhD

Phone

+862087330484

yan2011@tom.com

First Name & Middle Initial & Last Name & Degree

Jianhua Yan, MD, PhD

First Name & Middle Initial & Last Name & Degree

Tao Shen, MD, PhD

Facility Name

The first affiliated hospital of Nanjing University

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210029

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hu Liu, MD, PhD

Phone

+8613952091066

liuhu66@163.com

First Name & Middle Initial & Last Name & Degree

Hu Liu, MD, PhD

First Name & Middle Initial & Last Name & Degree

Zhenhua Leng, MD, PhD

First Name & Middle Initial & Last Name & Degree

Hui Zhu, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

12742836

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 Ophthalmol. 2003 May;121(5):603-11. doi: 10.1001/archopht.121.5.603.

Results Reference

result

PubMed Identifier

14597512

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 children. Ophthalmology. 2003 Nov;110(11):2075-87. doi: 10.1016/j.ophtha.2003.08.001.

Results Reference

result

PubMed Identifier

15824215

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 amblyopia in children aged 7 to 17 years. Arch Ophthalmol. 2005 Apr;123(4):437-47. doi: 10.1001/archopht.123.4.437.

Results Reference

result

PubMed Identifier

28626815

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. eCollection 2017 Jun.

Results Reference

result

PubMed Identifier

22336120

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.

Results Reference

result

PubMed Identifier

28162193

Citation

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. Chinese.

Results Reference

result

Learn more about this trial

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

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