Clinical trial NCT04238065: A Clinical Trial of Caterna Virtual Reality Facilitating Treatment in Children With Amblyopia
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
Overall status: UNKNOWN
Phase: NA
Conditions: Amblyopia
Keywords: Amblyopia; Virtual Reality
Lead sponsor: Guangzhou Shijing Medical Software
Sponsor class: INDUSTRY
Collaborators: name: The First Affiliated Hospital with Nanjing Medical University
name: The First Affiliated Hospital of Beijing University
name: Zhongshan Ophthalmic Center, Sun Yat-sen University
First posted: 2020-01-23
Enrollment: 300
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effectiveness of amblyopia treatment with VR
timeFrame: 13 weeks
Secondary outcomes:
measure: Effectiveness of 8 weeks' VR amblyopia treatment
timeFrame: 8 weeks
measure: Effectiveness of 4 weeks' VR amblyopia treatment
timeFrame: 4 weeks
measure: Stereopsis: distance and near, respectively
timeFrame: 13 weeks
measure: Contrast sensitivity function(CSF)
timeFrame: 13 weeks
Other outcomes:
measure: Severe Adverse Event Number
timeFrame: 13 weeks
Locations:
city: Beijing
country: China
facility: the first affiliated hospital of Beijing University
state: Beijing
city: Guangzhou
country: China
facility: Guangzhou Shijing Medical Software Co., Ltd.
state: Guangdong
city: Guanzhou
country: China
facility: Zhongshan Ophthalmic center, Sun Yat-sen University
state: Guangdong
city: Nanjing
country: China
facility: The first affiliated hospital of Nanjing University
state: Jiangsu
Study officials:
affiliation: Guangzhou Shijing Medical Software
name: Xiaohong Liu
role: STUDY_DIRECTOR
affiliation: Guangzhou Shijing Medical Software
name: Mosheng Zhou
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.