4 Week s Report for Virtual Reality on Children Amblyopia Therapy

Research Article

Austin J Clin Ophthalmol. 2023; 10(5): 1155.

4 Week’s Report for Virtual Reality on Children Amblyopia Therapy

Kaikai Qiu

Tianming Ophthalmology and Optometry Clinics, Dali, 671099, Yunnan, China

*Corresponding author: Kaikai Qiu Tianming Ophthalmology and Optometry Clinics, Dali, 671099, Yunnan, Airdoc MPC Co, Ltd, F4, No.2 North Road, Haidian District, Beijing, 100081, China. Email: kkaiqiu@126.com

Received: March 10, 2023 Accepted: April 24, 2023 Published: May 01, 2023

Abstract

Purpose: To compare safety and Visual Acuity (VA) improvement in children with amblyopia treated with Virtual Reality (VR) plus spectacle correction and patching versus. spectacle correction and patching only.

Design: Multicenter randomized clinical trial.

Subjects: Twenty-eight subjects aged 4 to 12 years with amblyopia (20/400 to 20/25) from strabismus, refractive amblyopia, and visual deprivation amblyopia or combined types according to “Consensus of experts in the diagnosis of Amblyopia” in 2011 by Chinese Ophthalmology Society. Subjects were required to have never been treated or stopped treatment of patching over 4 weeks prior to enrollment. Subjects were randomly assigned to either VR games for 0.5 hour a day with patching and spectacles correction (12 subjects; VR group) or patching and spectacles correction (18 subjects; control group). Study follow-up visits were scheduled at 4, 8, and 13 weeks. This paper was only for 4 weeks.

Methods: Eligible subjects (mean baseline corrected logMarVA was 0.54±0.28) were randomly assigned to treatment for 4 weeks with the VR binocular therapy (prescribed for 30min per day 3 days per week) plus spectacle correction and patching if needed (n=12) or spectacle correction with patching if needed (n=16). Main outcome measures: Advent event in VR group and change in amblyopic-eye VA from baseline to 4 weeks, assessed by a masked examiner.

Results: Safety: All 28 children reported no severe adverse event or device failure rate during 4 weeks of treatment; There was no significant difference between the dropping BCVA of fellow eye between VR group and control group. There were 12 and 16 experimental groups and control groups in baseline group, respectively, 8 and 6 completed complete 4-week treatment and follow-up.

Effective: At Week 4, the VR group had a significant improvement in BCVA (logMarVA=0.4±0.35) compared to baseline BCVA (logMarVA=0.575±0.34) (P=0.029, t-test); The BCVA of the relatively good eyes in the experimental group improved but was not significant (logMarVA increased from baseline 0.169 to 0.115); At the baseline, there was no significant difference between the baseline and the control group, with the average BCVA of 0.575 to 0.34, 0.588 to 0.26 (P=0.914), and after 4 weeks of treatment, the VR group had an average BCVA (0.40±0.35, n=6), higher than the control group’s average BCVA (0.525 ± 0.26, n=8), but the difference was not significant (P=0.458).

Conclusions: Caterna Virtual Reality was safe with a viable treatment option for the children amblyopia. Combining therapy of VR, spectacles and patching at baseline significantly improved the BCVA at 4 weeks.

Introductions

The standard amblyopia treatment in the recent decades included refractive correction at first, followed necessary patching or atropine penalization to the sound eye [1].

A challenge of amblyopia treatment was that some amblyope after many years’ standard therapies, still ended in residual amblyopia. And the rate was approximately 15–50%, who failed to achieve normal vision even after extended periods of treatment [2].

Besides baseline treatment ages, initiate severity, and combined pathology such as nystagmus, congenital cataract, or albinismus, another alternative explanation for failure to achieve normal vision was that standard treatments of recent years took too long and too boring to keep compliance with standard prescription. While compliance was significant related with the treatment results [3].

Moreover, standard amblyopia treatment had significant heterogeneity [4] no matter refraction adaptation period or occlusion periods. Following the standard treatment would also get other side effects, such as delay emmetropization. A Randomized Control Trial (RCT) study by Ingram et al. (n=287) [5], showed that those who were prescribed full correction from the age of 6 months and had good adherence to glasses wear, the effect on emmetropization was significantly delayed in comparison to those who were poor compliers or were not prescribed any refractive correction.

Amblyopia, a unilateral, less often bilateral condition with abnormal Best-Corrected Visual Acuity (BCVA) due to a mismatch between the images perceived with each eye, caused by early life abnormal visual experience such as visual deprivation, unequal refractive errors, or strabismus. Besides reduced BCVA, amblyopia had a plethora of visual deficits, including time delay of vision [6], reduced contrast sensitivity [7], and suppression [8]. And unilateral amblyopia affects two eyes [9].

In nature history, amblyopia, was a permanent visual impairment with a risk factor for 1.2% blindness [10]. For this reason, the early and sufficient treatment of this condition was crucial.

However, the mainstream standard therapies resulted with commonly mild residual amblyopia [11] with only 50%-85% achieving normal vision [12–15]. Moreover, clinical studies had elucidated that the time constant for successful patching was long: About 26% improvement for each 120h patching, as well as only 48% average concordance [14]. On the contrary, active therapy such as perceptual learning, and video games, would be more efficient to get the same improvement [16].

Binocular therapy had been used to treat amblyopia in children with some binocularity [17,18]. Images were presented dichoptically; high-contrast images were presented to the amblyopic eye and low-contrast images were presented to the fellow eye. However, the results were complicated with difference such as promising studies [19-22] or not as good as patching [23]. However, all those binocular therapies were compared to patching after sufficient optical correction time. And each study had different games and different adherence. To our best knowledge, there’s no RCT study on Virtual Reality (VR) for children amblyopia with combining VR plus patching and optical correction at baseline.

VR was an innovative binocular approach to treating amblyopia with two screens on either eye. It could do the patching or dichoptic therapy by changing either screen’s illumination, contrast, as well as speed of displaying sequence for the same or different image. And there was some adult amblyopia treatment study using VR with significant improving results [24]. And we wondered if the VR would facilitate patching and optical treatment to children amblyopia.

The purpose of the present randomized clinical trial was to establish whether treatment of amblyopia with VR dichoptic games (prescribed 0.5 hour per day for 13 weeks) plus spectacles wear (if needed) combined with patching was clinically safe and effective in BCVA of children amblyopia; As well as whether VR group would be superior than treatment only with spectacle wear (if needed) and patching of the sound eye in children age 4 to 12 years, with 20/25 to 20/200 BCVA of amblyopia eyes. And this paper focused the results on BCVA at 4 weeks for the above purpose.

Methods

The study was conducted at 3 clinical sites and approved by the Institutional Review Boards (IRB) of Jiangsu Province Hospital. All patients or guardians were informed about the study protocol and provided a written informed consent following the tenets of the Declaration of Helsinki. And each participant assented to subject as required. The study protocol was approved by the Ethics Committe of Jiangsu Province Hospital on January 8th, 2019. The study was registered on www.clinicaltrials.gov, under identifier NCT04238065. Eligibility criteria was listed in Table 1.