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

October 14, 2015 updated by: Xiang Chen, Sun Yat-sen University
This study aims to determine the treatment effect of accommodative/vergence therapy on myopic children by assessment of accommodative function before and after therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Zhongshan Ophthalmic Center
        • Contact:
        • Sub-Investigator:
          • Martin Ma, BSc
        • Sub-Investigator:
          • Candy Su, College
        • Sub-Investigator:
          • Chao Chen, College
        • Sub-Investigator:
          • JunCheng Wang, College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Accommodative/Vergence Therapy
Accommodative/Vergence Therapy. No drug involved.
Other: accommodative/vergence therapy
12 weekly accommodative/vergence therapies

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in lag of accommodation assessed by open-field autorefractor from baseline visit at 6 months after 12 weekly vision therapies
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 )
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in accommodative amplitude assessed by push-up technique from baseline visit at 6 months after 12 weekly vision therapies
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 )
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.
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
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 )
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.
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
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 )
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.
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 )

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xiang Chen, Ph.D, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 19, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015ACC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings