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Status unknownNCT04238065VRTAUpdated Feb 5, 2020

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

An interventional study of Caterna Virtual Reality and Spectacles(Best optical corrected distance vision) in Amblyopia, sponsored by Guangzhou Shijing Medical Software. Status unknown at 4 sites in China. Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2020-02-05.

Sponsored by Guangzhou Shijing Medical Software · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Sep 2019, registered Jan 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
4 Years to 12 Years
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • Amblyopia

Browse trials for

Keywords

  • Amblyopia; Virtual Reality
03

In context

Amblyopia

189 studies on the registry are indexed under Amblyopia; 41 are open to participants now.

This study's planned enrollment of 300 is above the median of 60 across 137 interventional studies indexed under Amblyopia.

Browse Amblyopia studies →

Lead sponsor

Guangzhou Shijing Medical Software is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form; And the subject can cooperate with the whole treatment and related eye examinations。 -

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    VR treatment

    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.

    Device: Caterna Virtual Reality · Device: Spectacles(Best optical corrected distance vision) · Device: Patch

  • Placebo comparator
    control

    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.

    Device: Spectacles(Best optical corrected distance vision) · Device: Patch

Interventions

  • DeviceCaterna 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.

    Also known as: SJ-VRS2018, DOBOSO VR, Vision Therapy Software

  • DeviceSpectacles(Best optical corrected distance vision)

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

    Also known as: Optical correction

  • DevicePatch

    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

    Also known as: Occlusion

06

What researchers measure

Primary outcomes

  1. Effectiveness of amblyopia treatment with VR

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

    Time frame: 13 weeks

Secondary outcomes

  1. Effectiveness of 8 weeks' VR amblyopia treatment

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

    Time frame: 8 weeks

  2. Effectiveness of 4 weeks' VR amblyopia treatment

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

    Time frame: 4 weeks

  3. Stereopsis: distance and near, respectively

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

    Time frame: 13 weeks

  4. Contrast sensitivity function(CSF)

    Difference between those final CSF and baseline CSF

    Time frame: 13 weeks

Other outcomes

  1. Severe Adverse Event Number

    Total number of Severe Adverse Event

    Time frame: 13 weeks

07

Study locations

3 of 4 sites recruiting
  • the first affiliated hospital of Beijing University
    Beijing, Beijing 100045, China
    Recruiting
    • Xiaoqing Li, MD, PhD · Contactfangfeilee8@126.com · +861083572336
    • Yiwen Cao, MD, PhD · Contactertongyanke@126.com · +8613269978261
    • Xiaoqing Li, MD, PhD · Principal investigator
    • Jing Wen, MD, PhD · Sub investigator
    • Yiwen Cao, MD, PhD · Sub investigator
  • Guangzhou Shijing Medical Software Co., Ltd.
    Guangzhou, Guangdong 510000, China
    Active, not recruiting
  • Zhongshan Ophthalmic center, Sun Yat-sen University
    Guanzhou, Guangdong 510000, China
    Recruiting
    • Jianhua Yan, MD, PhD · Contactyan2011@tom.com · +862087330484
    • Jianhua Yan, MD, PhD · Principal investigator
    • Tao Shen, MD, PhD · Sub investigator
  • The first affiliated hospital of Nanjing University
    Nanjing, Jiangsu 210029, China
    Recruiting
    • Hu Liu, MD, PhD · Contactliuhu66@163.com · +8613952091066
    • Hu Liu, MD, PhD · Principal investigator
    • Zhenhua Leng, MD, PhD · Sub investigator
    • Hui Zhu, MD, PhD · Sub investigator
08

References and documents

Publications

  • 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. PubMed 12742836 ↗
  • 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. PubMed 14597512 ↗
  • 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. PubMed 15824215 ↗
  • 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. PubMed 28626815 ↗
  • 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. PubMed 22336120 ↗
  • 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. PubMed 28162193 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2019 (actual). Primary completion is estimated for Dec 2020, 15 months after the start.

Of 71 interventional studies with no phase under Amblyopia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 47. This study's planned 15 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 18, 2020
First posted
Jan 23, 2020
StartActual
Sep 4, 2019
Primary completionEst.
Dec 31, 2020
CompletionEst.
Dec 31, 2021
Last update
Feb 5, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04238065
Lead 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
Responsible party
Sponsor
First posted
Jan 23, 2020
Start date
Sep 4, 2019
Primary completion
Dec 31, 2020 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Feb 5, 2020

Study contacts

Jenny Qiu, MD
Contact
qiukk@topeye.cn
+8618510386815
Taylor Zhu, MS
Contact
zhuda@topeye.cn
+8613060934107
Xiaohong Liu
study director · Guangzhou Shijing Medical Software
Mosheng Zhou
study chair · Guangzhou Shijing Medical Software

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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