CClinicalTrials.gg
Sign In
Status unknownNCT02578407ACCUpdated Oct 19, 2015

Pilot Study of Accommodative/Vergence Therapy to Modify Accommodative Function in Children With Myopia

An interventional study of accommodative/vergence therapy in Myopia, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 8 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-19.

Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
8 Years to 12 Years
Sex
All
01

Study 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.

Read the detailed description

  1. Specific aims of the proposed clinical trial:

    1.1 To prove accommodative/vergence therapy (AT) can normalize the accommodative function of myopic children.。 1.2 If the accommodation function of myopic children can be improved with AT therapy, the outcome will supply a basic for a randomized, multi-center clinic trail to determine the effectiveness of AT to slow the progression of myopia.

  2. Hypothesis:

Accommodative/vergence therapy can normalize the accommodative functions of 8-12 years old Chinese myopic children.

02

Conditions studied

  • Myopia

Browse trials for

03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's planned enrollment of 30 is below the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Subjects enrolled in the trial must:

  1. be within the age range of 8 to 12 years old inclusive;
  2. -0.75d to -4.50dspherical equivalent by cycloplegic autorefraction in both eyes
  3. astigmatism≤1.5d in both eyes；
  4. anisometropia≤1.0d；
  5. accommodation lag at near(33cm）in right eye by non-cycloplegic auto- refraction ≧1d;
  6. have vision correctable to at least 0.8 or better in each eye.

Exclusion criteria

Exclusion Criteria:

Subjects enrolled in the trial must NOT have:

  1. current or prior use of progressive addition lens, bifocals, or contact lenses in either eye( prior or current use of single vision lens allowed)；
  2. history of any of the following functional defects: strabismus, amblyopia, nystagmus；
  3. history of diabetes or seizures；
  4. history of any ocular systemic, or neuro-developmental condition that might influence refractive development；
  5. use of ocular or systemic medications known to affect accommodation, such as atropine, pirenzepine, and anti-epileptic medications in recent 3 months；
  6. history of any ocular surgery that might influence refractive development；
  7. 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；
  8. relocation anticipated for 3 years；
  9. birth weight lower than 1250 grams（2lbs,12oz）；
  10. siblings in the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Accommodative/Vergence Therapy

    Accommodative/Vergence Therapy. No drug involved.

    Other: accommodative/vergence therapy

Interventions

  • Otheraccommodative/vergence therapy

    12 weekly accommodative/vergence therapies

06

What researchers measure

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.

    Time frame: 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

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

    We will measure the accommodative amplitude in right eye by using push-up technique with the use of Gulden accommodation rule. An average of 3 measurements will be recorded in spherical dioptric power.

    Time frame: 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 )

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

    We will measure the level of fluctuation in lag of accommodation at 33 cm objectively by using open-field autorefractor. A 1 minute continuous measurement will be taken in right eye. The unit of measurement is spherical equivalent dioptric power.

    Time frame: 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 )

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

    We will measure the accommodative facility at 40 cm by flipper bar method using a ±2.00 diopters lens flipper. 1 measurement will be taken in right eye. The unit of measurement is cycles per minute.

    Time frame: 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 )

07

Study locations

1 of 1 sites recruiting
  • Zhongshan Ophthalmic Center
    Guangzhou, Guangdong 510080, China
    • Xiang Chen, Ph.D. · Contact · chen1094@hotmail.com · 87334687
    • Martin Ma, BSc · Sub investigator
    • Candy Su, College · Sub investigator
    • Chao Chen, College · Sub investigator
    • JunCheng Wang, College · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02578407
Lead sponsor
Sun Yat-sen University
Responsible party
Xiang Chen (Head, Operation office of Clinical Research Center Institution of Drug Clinical Trials,Zhongshan Opthalmic Center of Sun Yat-sen University, Sun Yat-sen University) — Principal investigator
First posted
Oct 19, 2015
Start date
Sep 2015
Primary completion
Sep 2016 (estimated)
Completion
Sep 2016 (estimated)
Last update
Oct 19, 2015

Study contacts

Xiang Chen, Ph.D
Contact
chen1094@hotmail.com
87334687 ext. 87334687
Xiang Chen, Ph.D
principal investigator · Zhongshan Ophthalmic Center, Sun Yat-sen University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Myopia→

Other studies from this sponsor

Sun Yat-sen University

Start the discussion