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

Primary Purpose

Myopia

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

accommodative/vergence therapy

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects enrolled in the trial must:

be within the age range of 8 to 12 years old inclusive;
-0.75d 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.

Exclusion Criteria:

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.

Sites / Locations

Zhongshan Ophthalmic CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Accommodative/Vergence Therapy

Arm Description

Accommodative/Vergence Therapy. No drug involved.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT02578407

First Posted

October 10, 2015

Last Updated

October 14, 2015

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT02578407

Brief Title

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

Acronym

ACC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Unknown status

Study Start Date

September 2015 (undefined)

Primary Completion Date

September 2016 (Anticipated)

Study Completion Date

September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myopia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Accommodative/Vergence Therapy

Arm Type

Experimental

Arm Description

Accommodative/Vergence Therapy. No drug involved.

Intervention Type

Other

Intervention Name(s)

accommodative/vergence therapy

Intervention Description

12 weekly accommodative/vergence therapies

Primary Outcome Measure Information:

Title

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

Description

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 Outcome Measure Information:

Title

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

Description

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 )

Title

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

Description

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 )

Title

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

Description

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 )

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects enrolled in the trial must: be within the age range of 8 to 12 years old inclusive; -0.75d 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiang Chen, Ph.D

Phone

87334687

Ext

87334687

chen1094@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiang Chen, Ph.D

Organizational Affiliation

Zhongshan Ophthalmic Center, Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhongshan Ophthalmic Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiang Chen, Ph.D.

Phone

87334687

chen1094@hotmail.com

First Name & Middle Initial & Last Name & Degree

Martin Ma, BSc

First Name & Middle Initial & Last Name & Degree

Candy Su, College

First Name & Middle Initial & Last Name & Degree

Chao Chen, College

First Name & Middle Initial & Last Name & Degree

JunCheng Wang, College

12. IPD Sharing Statement

Learn more about this trial

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

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