NCT01756287

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 25, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

June 18, 2014

Status Verified

June 1, 2014

Enrollment Period

1.3 years

First QC Date

December 20, 2012

Last Update Submit

June 17, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Distant and near visual acuity

    Before and after the intervention immediately, about 5 minutes

Secondary Outcomes (1)

  • Ocular accommodation

    Before and after the intervention immediately, about 5 minutes

Other Outcomes (1)

  • Self evaluation of the improvement after the intervention

    Before and after the intervention immediately, about 5 minutes

Study Arms (3)

Standardized Chinese ocular exercise

EXPERIMENTAL

The participants are trained with standardized Chinese ocular exercise which contains accurate positions of acupuncture points and appropriate pressure on the points.

Other: Chinese ocular exercise

Nonstandardized ocular exercise

SHAM COMPARATOR

The participants are trained with nonstandardized ocular exercise performed on wrong positions where no acupuncture points at all.

Other: Chinese ocular exercise

Eye closure

NO INTERVENTION

The participants are told to close eyes and don't do ocular exercise at all.

Interventions

A kind of massage around the acupuncture points around the eye.

Nonstandardized ocular exerciseStandardized Chinese ocular exercise

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Visual acuity: 20/20 or better in each eye;
  • 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
  • No strabismus, amblyopia and any other ocular or systematic diseases that may affect refractive development

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shi-Ming Li

Anyang, Henan, 455000, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Ningli Wang, MD, PhD

    Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

December 20, 2012

First Posted

December 25, 2012

Study Start

August 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

June 18, 2014

Record last verified: 2014-06

Locations