Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| The First Affiliated Hospital of Beijing University | UNKNOWN |
| Zhongshan Ophthalmic Center, Sun Yat-sen University | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of amblyopia treatment with VR | General Effectiveness=Number of both cured eyes and effective eyes from total number×100% | 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of 8 weeks' VR amblyopia treatment | General Effectiveness=Number of both cured eyes and effective eyes from total number×100% | 8 weeks |
| Effectiveness of 4 weeks' VR amblyopia treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Severe Adverse Event Number | Total number of Severe Adverse Event | 13 weeks |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jenny Qiu, MD | Contact | +8618510386815 | qiukk@topeye.cn | |
| Taylor Zhu, MS | Contact | +8613060934107 | zhuda@topeye.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaohong Liu | Guangzhou Shijing Medical Software | Study Director |
| Mosheng Zhou | Guangzhou Shijing Medical Software | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the first affiliated hospital of Beijing University | Recruiting | Beijing | Beijing Municipality | 100045 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12742836 | Result | 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. | |
| 14597512 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000550 | Amblyopia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014786 | Vision Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D057968 | Transdermal Patch |
| D003766 | Dental Occlusion |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
| D003813 | Dentistry |
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
Not provided
Not provided
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.
Not provided
Not provided
Research centers are used as a stratification factor. The researchers include subjects in the trial group or control group based on randomized envelopes.
|
|
| Spectacles(Best optical corrected distance vision) | Device | Each eye has best corrected vision spectacles with best corrected optical lens. |
|
|
| 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 |
|
|
General Effectiveness=Number of both cured eyes and effective eyes from total number×100%
| 4 weeks |
| Stereopsis: distance and near, respectively | Ratio of stereopsis perception=(Number of stereopsis perception /Total number)*100% | 13 weeks |
| Contrast sensitivity function(CSF) | Difference between those final CSF and baseline CSF | 13 weeks |
| Guangzhou Shijing Medical Software Co., Ltd. | Active, not recruiting | Guangzhou | Guangdong | 510000 | China |
| Zhongshan Ophthalmic center, Sun Yat-sen University | Recruiting | Guanzhou | Guangdong | 510000 | China |
|
| The first affiliated hospital of Nanjing University | Recruiting | Nanjing | Jiangsu | 210029 | China |
|
| 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. |
| 15824215 | 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. |
| 28626815 | 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. |
| 22336120 | 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. |
| 28162193 | 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. |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |