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

Myopia Clinical Trial

— ACC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02578407
• Other study ID #: 2015ACC
• Status: Recruiting
• Phase: N/A
• First received: October 10, 2015
• Last updated: October 14, 2015
• Start date: September 2015
• Est. completion date: September 2016

Study information

• Verified date: October 2015
• Source: Sun Yat-sen University
• Contact: Xiang Chen, Ph.D
• Phone: 87334687
• Email: chen1094[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Other:
• accommodative/vergence therapy
12 weekly accommodative/vergence therapies

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 )	No
Secondary	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.	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 )	No
Secondary	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.	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 )	No
Secondary	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.	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 )	No