NCT02578407

Brief Summary

This study aims to determine the treatment effect of accommodative/vergence therapy on myopic children by assessment of accommodative function before and after therapy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 10, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 19, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 19, 2015

Status Verified

October 1, 2015

Enrollment Period

1 year

First QC Date

October 10, 2015

Last Update Submit

October 14, 2015

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • Change in lag of accommodation assessed by open-field autorefractor from baseline visit at 6 months after 12 weekly vision therapies

    We will measure the lag of accommodation objectively in right eye at 33 cm by using open-field autorefractor. An average of 10 static measurements will be recorded in spherical equivalent dioptric power.

    Baseline visit, 7th visit(7 weeks after BL), 13th visit (13 weeks after BL), 14th visit(9months after BL, which is also 6months after vision therapies )

Secondary Outcomes (3)

  • Change in accommodative amplitude assessed by push-up technique from baseline visit at 6 months after 12 weekly vision therapies

    Baseline visit, 7th visit(7 weeks after BL), 13th visit (13 weeks after BL), 14th visit(9months after BL, which is also 6months after vision therapies )

  • Change in accommodative variability assessed by open-field autorefractor from baseline visit at 6 months after 12 weekly vision therapies

    Baseline visit, 7th visit(7 weeks after BL), 13th visit (13 weeks after BL), 14th visit(9months after BL, which is also 6months after vision therapies )

  • Change in accommodative facility assessed by flipper bar method from baseline visit at 6 months after 12 weekly vision therapies

    Baseline visit, 7th visit(7 weeks after BL), 13th visit (13 weeks after BL), 14th visit(9months after BL, which is also 6months after vision therapies )

Study Arms (1)

Accommodative/Vergence Therapy

EXPERIMENTAL

Accommodative/Vergence Therapy. No drug involved.

Other: accommodative/vergence therapy

Interventions

accommodative/vergence therapyOTHER

12 weekly accommodative/vergence therapies

Accommodative/Vergence Therapy

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Subjects enrolled in the trial must:
  • be within the age range of 8 to 12 years old inclusive;
  • d to -4.50dspherical equivalent by cycloplegic autorefraction in both eyes
  • astigmatism≤1.5d in both eyes；
  • anisometropia≤1.0d；
  • accommodation lag at near(33cm）in right eye by non-cycloplegic auto- refraction ≧1d;
  • have vision correctable to at least 0.8 or better in each eye.

You may not qualify if:

  • Subjects enrolled in the trial must NOT have:
  • current or prior use of progressive addition lens, bifocals, or contact lenses in either eye( prior or current use of single vision lens allowed)；
  • history of any of the following functional defects: strabismus, amblyopia, nystagmus；
  • history of diabetes or seizures；
  • history of any ocular systemic, or neuro-developmental condition that might influence refractive development；
  • use of ocular or systemic medications known to affect accommodation, such as atropine, pirenzepine, and anti-epileptic medications in recent 3 months；
  • history of any ocular surgery that might influence refractive development；
  • developmental disability, attention deficit hyperactivity disorder(ADHD), or learning disability diagnosis in children that in the investigator's discretion would interfere with office-based treatment；
  • relocation anticipated for 3 years；
  • birth weight lower than 1250 grams（2lbs,12oz）；
  • siblings in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Xiang Chen, Ph.D

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiang Chen, Ph.D

CONTACT

87334687chen1094@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Operation office of Clinical Research Center Institution of Drug Clinical Trials,Zhongshan Opthalmic Center of Sun Yat-sen University

Study Record Dates

First Submitted

October 10, 2015

First Posted

October 19, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

October 19, 2015

Record last verified: 2015-10

Locations

CN(1)