AmblyopiaVRTANCT04238065
A Clinical Trial of Caterna Virtual Reality Facilitating Treatment in Children With Amblyopia
A study testing Caterna Virtual Reality, Spectacles(Best optical corrected distance vision) and Patch in people with Amblyopia, run by Guangzhou Shijing Medical Software at 4 sites in China.
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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- Caterna Virtual Reality, Spectacles(Best optical corrected distance vision) and Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 4 sitesChina
- Study dates
- 4 Sep 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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。 -
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 3 recruiting
- Recruiting
the first affiliated hospital of Beijing University
Beijing, Beijing Municipality, 100045
Xiaoqing Li, MD, PhD, +861083572336, fangfeilee8@126.com
Yiwen Cao, MD, PhD, +8613269978261, ertongyanke@126.com
- Active, not recruiting
Guangzhou Shijing Medical Software Co., Ltd.
Guangzhou, Guangdong, 510000
- Recruiting
Zhongshan Ophthalmic center, Sun Yat-sen University
Guanzhou, Guangdong, 510000
Jianhua Yan, MD, PhD, +862087330484, yan2011@tom.com
Jianhua Yan, MD, PhD
- Recruiting
The first affiliated hospital of Nanjing University
Nanjing, Jiangsu, 210029
Hu Liu, MD, PhD, +8613952091066, liuhu66@163.com
Hu Liu, MD, PhD
About this study
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
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.
- Conditions
- Amblyopia
- Being tested
- Caterna Virtual Reality, Spectacles(Best optical corrected distance vision), Patch
- Keywords
- Amblyopia; Virtual Reality
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caterna Virtual RealityDevice
Also called SJ-VRS2018, DOBOSO VR, Vision Therapy Software
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)Device
Also called Optical correction
Each eye has best corrected vision spectacles with best corrected optical lens.
PatchDevice
Also called Occlusion
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
| Study group | Role | What they receive |
|---|---|---|
| VR treatment | Experimental | 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. Receives: Device: Caterna Virtual Reality; Device: Spectacles(Best optical corrected distance vision); Device: Patch |
| control | Placebo comparator | 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. Receives: Device: Spectacles(Best optical corrected distance vision); Device: Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of amblyopia treatment with VR
General Effectiveness=Number of both cured eyes and effective eyes from total number×100%
Measured: 13 weeks
Secondary outcomes (4)
Effectiveness of 8 weeks' VR amblyopia treatment
General Effectiveness=Number of both cured eyes and effective eyes from total number×100%
Measured: 8 weeks
Effectiveness of 4 weeks' VR amblyopia treatment
General Effectiveness=Number of both cured eyes and effective eyes from total number×100%
Measured: 4 weeks
Stereopsis: distance and near, respectively
Ratio of stereopsis perception=(Number of stereopsis perception /Total number)*100%
Measured: 13 weeks
Contrast sensitivity function(CSF)
Difference between those final CSF and baseline CSF
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start4 Sep 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Shijing Medical Software
- Sponsor type
- Industry (pharma, biotech, devices)
- 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
- Investigators
- Xiaohong Liu, Study director, Guangzhou Shijing Medical SoftwareMosheng Zhou, Study chair, Guangzhou Shijing Medical Software
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238065
- Sponsor's protocol ID
- GuangzhouShijingMS
- Acronym
- VRTA
- Status last verified
- Jan 2020
- First submitted
- 18 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 12742836Holmes 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 14597512Scheiman 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 15824215Yazdani 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 28626815Jin 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 22336120He 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04238065
- Acronym / sponsor ID
- VRTA / GuangzhouShijingMS
- Conditions
- Amblyopia
- Keywords
- Amblyopia; Virtual Reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Guangzhou Shijing Medical SoftwareIndustry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, The First Affiliated Hospital of Beijing University, Zhongshan Ophthalmic Center, Sun Yat-sen University
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| VR treatment | Experimental | Device: Caterna Virtual Reality, Device: Spectacles(Best optical corrected distance vision), Device: PatchThe 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. |
| control | Placebo comparator | Device: Spectacles(Best optical corrected distance vision), Device: PatchThis 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. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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。 -
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caterna Virtual RealityAlso: SJ-VRS2018, DOBOSO VR, Vision Therapy SoftwareVivid 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. | Device | VR treatment |
| Spectacles(Best optical corrected distance vision)Also: Optical correctionEach eye has best corrected vision spectacles with best corrected optical lens. | Device | VR treatment, control |
| PatchAlso: Occlusion2 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 | Device | VR treatment, control |
Primary outcome
Effectiveness of amblyopia treatment with VR
Time frame: 13 weeks
General Effectiveness=Number of both cured eyes and effective eyes from total number×100%
4 secondary outcomes
Effectiveness of 8 weeks' VR amblyopia treatment
Time frame: 8 weeks
Effectiveness of 4 weeks' VR amblyopia treatment
Time frame: 4 weeks
Stereopsis: distance and near, respectively
Time frame: 13 weeks
Contrast sensitivity function(CSF)
Time frame: 13 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Results publication: PubMed 12742836Repka 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 publication: PubMed 14597512Holmes 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 publication: PubMed 15824215Scheiman 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 publication: PubMed 28626815Yazdani 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 publication: PubMed 22336120Jin 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 publication: PubMed 28162193He 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaohong Liu study director
Guangzhou Shijing Medical Software
Mosheng Zhou study chair
Guangzhou Shijing Medical Software
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caterna Virtual Reality, Spectacles(Best optical corrected distance vision) and Patch in people with Amblyopia, run by Guangzhou Shijing Medical Software at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jenny Qiu, MD (+8618510386815, qiukk@topeye.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of amblyopia treatment with VR (time frame: 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04238065, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.