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

NCT04238065 | Unknown DMC

• 1 other identifier: GuangzhouShijingMS
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 4

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.

Conditions

Amblyopia

Keywords

Amblyopia; Virtual Reality

Outcome Measures

Primary Outcomes (1)

• Effectiveness of amblyopia treatment with VR

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

  13 weeks

Secondary Outcomes (4)

• Effectiveness of 8 weeks' VR amblyopia treatment

  8 weeks

• Effectiveness of 4 weeks' VR amblyopia treatment

  4 weeks

• Stereopsis: distance and near, respectively

  13 weeks

• Contrast sensitivity function(CSF)

  13 weeks

Other Outcomes (1)

• Severe Adverse Event Number

  13 weeks

Study Arms (2)

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.

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.

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

Interventions

Caterna Virtual Reality DEVICE

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

VR treatment

Spectacles(Best optical corrected distance vision) DEVICE

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

Also known as: Optical correction

VR treatment; control

Patch DEVICE

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

VR treatment; control

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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。 -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Shijing Medical Software: lead
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• The First Affiliated Hospital of Beijing University: collaborator
• Zhongshan Ophthalmic Center, Sun Yat-sen University: collaborator

Study Sites (4)

the first affiliated hospital of Beijing University

Beijing, Beijing Municipality, 100045, China

RECRUITING

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

The first affiliated hospital of Nanjing University

Nanjing, Jiangsu, 210029, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 12742836 RESULT

• 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.

  PMID: 14597512 RESULT

• 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.

  PMID: 15824215 RESULT

• 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.

  PMID: 28626815 RESULT

• 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.

  PMID: 22336120 RESULT

• 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.

  PMID: 28162193 RESULT

MeSH Terms

Conditions

Amblyopia

Interventions

Transdermal Patch; Dental Occlusion

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Xiaohong Liu

  Guangzhou Shijing Medical Software

  STUDY DIRECTOR

• Mosheng Zhou

  Guangzhou Shijing Medical Software

  STUDY CHAIR

Central Study Contacts

Jenny Qiu, MD

CONTACT

+8618510386815; qiukk@topeye.cn

Taylor Zhu, MS

CONTACT

+8613060934107; zhuda@topeye.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Research centers are used as a stratification factor. The researchers include subjects in the trial group or control group based on randomized envelopes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 18, 2020
• First Posted: January 23, 2020
• Study Start: September 4, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: February 5, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)