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

NCT ID: NCT02578407

Last Updated: 2015-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-09-30

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

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.

Conditions

Myopia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Accommodative/Vergence Therapy

Accommodative/Vergence Therapy. No drug involved.

Group Type: EXPERIMENTAL

accommodative/vergence therapy

Intervention Type: OTHER

12 weekly accommodative/vergence therapies

Interventions

accommodative/vergence therapy

12 weekly accommodative/vergence therapies

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Xiang Chen

Head, Operation office of Clinical Research Center Institution of Drug Clinical Trials,Zhongshan Opthalmic Center of Sun Yat-sen University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiang Chen, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiang Chen, Ph.D

Role: CONTACT

chen1094@hotmail.com

87334687 ext. 87334687

Facility Contacts

Xiang Chen, Ph.D.

Role: primary

chen1094@hotmail.com

87334687

Other Identifiers

2015ACC

Identifier Type: -

Identifier Source: org_study_id