MyopiaACCNCT02578407
Pilot Study of Accommodative/Vergence Therapy to Modify Accommodative Function in Children With Myopia
A study testing accommodative/vergence therapy in people with Myopia, run by Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- accommodative/vergence therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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；
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, 510080
Xiang Chen, Ph.D., 87334687, chen1094@hotmail.com
Martin Ma, BSc
About this study
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
- 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.
- Conditions
- Myopia
- Being tested
- accommodative/vergence therapy
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
accommodative/vergence therapyOther
12 weekly accommodative/vergence therapies
| Study group | Role | What they receive |
|---|---|---|
| Accommodative/Vergence Therapy | Experimental | Accommodative/Vergence Therapy. No drug involved. Receives: Other: accommodative/vergence therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (3)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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 )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiang Chen, Sun Yat-sen University
- Investigators
- Xiang Chen, Ph.D, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578407
- Sponsor's protocol ID
- 2015ACC
- Acronym
- ACC
- Status last verified
- Oct 2015
- First submitted
- 10 Oct 2015
- Last updated
- 19 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Accommodative/Vergence Therapy to Modify Accommodative Function in Children With Myopia
- ClinicalTrials.gov ID
- NCT02578407
- Acronym / sponsor ID
- ACC / 2015ACC
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 19 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accommodative/Vergence Therapy | Experimental | Other: accommodative/vergence therapyAccommodative/Vergence Therapy. No drug involved. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (11 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| accommodative/vergence therapy12 weekly accommodative/vergence therapies | Other | Accommodative/Vergence Therapy |
Primary outcome
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.
3 secondary outcomes
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 )
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 )
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 )
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2015.
Related trials for Myopia
Not yet recruitingObservational study
Corneal Biomechanics and Stromal Tissue Characteristics in Patients Undergoing SMILE
Myopia
Enrolling by invitation
Therapeutic Efficacy of Different Repeated Low-Intensity Red Light Devices and Different Usage Frequencies
Myopia
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruitingPhase 4
Odyssey Evaluation in Post LASIK Patients
Cataract
RecruitingPhase 3
A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
Myopia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiang Chen, Ph.D principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing accommodative/vergence therapy in people with Myopia, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiang Chen, Ph.D (87334687 ext. 87334687, chen1094@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2015.