Clinical trial NCT01756287: Efficacy of Chinese Ocular Exercise on Visual Acuity and Ocular Accommodation in Myopic Teenager
Official title: A Randomized Controlled Trial to Alter Ocular Accommodation in Myopic Teenager With Chinese Ocular Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2012-12-25
Enrollment: 190
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess whether Chinese ocular exercise is effective in altering distant and near visual acuity, ocular accommodation and visual symptoms in myopic teenager, and thus might have the possibility of slowing myopia progression in teenager through a weak but long-term effect.

Detailed description: Myopia is a public health problem worldwide, especially in some Asian countries like China, Singapore, and Japan. Chinese ocular exercise, originating in 1963 with the theory of Traditional Chinese Medicine, is a kind of massage on acupuncture points around the eye to prevent myopia and alleviate visual fatigue. The exercise has been spread as a community ritual and living habit of primary and high school students for nearly half a century. However, the prevalence of myopia in Chinese children increased remarkably in recent years. Therefore, the efficacy of Chinese ocular exercise on preventing myopia or alleviating visual fatigue is widely questioned. Evidence from clinical trials of high level is needed to clarify that whether Chinese ocular exercise is effective in slowing and preventing myopia progression, or at least in part in easing the symptoms related to myopia and visual fatigue.

Eligibility criteria: Inclusion Criteria:

1. Visual acuity: 20/20 or better in each eye;
2. Spherical error ranging from +0.5 D to -6.0 D and astigmatism less than 1.5 D in each eye, anisometropia less than 1.0 D between the two eyes Contact lens
3. No strabismus, amblyopia and any other ocular or systematic diseases that may affect refractive development

Exclusion Criteria:

1. Currently using other interventions to control myopia progression (acupuncture, massage, drugs, ear needles and so on)
2. Unable to cooperate with the ocular examination and questionnaire survey

Primary outcomes:
measure: Distant and near visual acuity
timeFrame: Before and after the intervention immediately, about 5 minutes
Secondary outcomes:
measure: Ocular accommodation
timeFrame: Before and after the intervention immediately, about 5 minutes
Other outcomes:
measure: Self evaluation of the improvement after the intervention
timeFrame: Before and after the intervention immediately, about 5 minutes
Locations:
city: Anyang
country: China
facility: Shi-Ming Li
state: Henan
Study officials:
affiliation: Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing, China
name: Ningli Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li SM, Kang MT, Peng XX, Li SY, Wang Y, Li L, Yu J, Qiu LX, Sun YY, Liu LR, Li H, Sun X, Millodot M, Wang N. Efficacy of Chinese eye exercises on reducing accommodative lag in school-aged children: a randomized controlled trial. PLoS One. 2015 Mar 5;10(3):e0117552. doi: 10.1371/journal.pone.0117552. eCollection 2015.