MyopiaNCT03006601
Effect of Vision Therapy in Myopic Children With Poor Accommodative Response
A study testing Office-based 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 vision 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?
- Office-based accommodative/vergence therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Dec 2017
- 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
- monocular accommodation lag at near(33cm)in right eye by non-cycloplegic autorefraction≧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 PALs, bifocals, or contact lenses in either eye( prior or current use of SVLs 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 containing 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 1 year
- birth weight lower than 1250 grams（2lbs,12oz）
- siblings in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Vision Therapy on Accommodation in Myopic Chinese Children With Poor Accommodative Response: A Randomized Clinical Trial
This study aims to determine the treatment effect of vision 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 provide a definitive proof that vision therapy (VT) can improve the accommodative function of myopic children by comparing the results from treatment group to placebo group. 1.2 To minimize the influences of confounding variables by randomly assigning the intervention. 1.3 To observe the longitudinal effects of VT on accommodation system and its effect on axial length.
- Hypothesis:
VT can improve the accommodative functions of 8-12 years old Chinese myopic children with poor accommodative response.
- Conditions
- Myopia
- Being tested
- Office-based 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.
Office-based accommodative/vergence therapyOther
Office-based accommodative/vergence therapy (60 minutes per visit, one time per week, 12 weeks) and home reinforcement (15 minutes each time, five times per week, 12 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | After enrollment, patients will be randomized into either treatment group or placebo group. Patients will receive placebo procedure which were designed to look like real vergence/accommodative therapy procedures yet not stimulate vergence, accommodation, of fine saccadic eye movement skills beyond normal daily visual activities. Office-based procedures (60 minutes per visit, one time per week, 12 weeks) and home procedures (15 minutes each time, five times per week, 12 weeks) will be provided to patients. Receives: Other: Office-based accommodative/vergence therapy |
| Treatment group | Experimental | After enrollment, patients will be randomized into either treatment group or placebo group. Office-based accommodative/vergence therapy (60 minutes per visit, one time per week, 12 weeks) and home reinforcement (15 minutes each time, five times per week, 12 weeks) will be provided to patients of treatment group. Receives: Other: Office-based accommodative/vergence therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of Accommodative response is being assessed
we will use objective measures from open-field auto refractor.
Measured: At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT.
Secondary outcomes (4)
the changes of Accommodative amplitude is being assessed:
we will use subjective measures from accommodative rod(push up method)
Measured: At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT.
the changes of Accommodative facility is being assessed:
we will use subjective measures from lens flipper
Measured: At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT.
the changes of Cycloplegic objective refraction is being assessed:
we will use objective measures from open-field auto refractor.
Measured: At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT.
the changes of Axial length is being assessed:
we will use objective measures from IOL-Master
Measured: At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study startSep 2016
- Primary completionFeb 2017 (estimated)
- Study completionDec 2017 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
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, PhD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006601
- Sponsor's protocol ID
- 2016AC2
- Status last verified
- Dec 2016
- First submitted
- 28 Oct 2016
- Last updated
- 30 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vision Therapy on Accommodation in Myopic Chinese Children With Poor Accommodative Response: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03006601
- Acronym / sponsor ID
- 2016AC2
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 30 Dec 2016 (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 vision 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 provide a definitive proof that vision therapy (VT) can improve the accommodative function of myopic children by comparing the results from treatment group to placebo group. 1.2 To minimize the influences of confounding variables by randomly assigning the intervention. 1.3 To observe the longitudinal effects of VT on accommodation system and its effect on axial length.
- Hypothesis:
VT can improve the accommodative functions of 8-12 years old Chinese myopic children with poor accommodative response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Other: Office-based accommodative/vergence therapyAfter enrollment, patients will be randomized into either treatment group or placebo group. Patients will receive placebo procedure which were designed to look like real vergence/accommodative therapy procedures yet not stimulate vergence, accommodation, of fine saccadic eye movement skills beyond normal daily visual activities. Office-based procedures (60 minutes per visit, one time per week, 12 weeks) and home procedures (15 minutes each time, five times per week, 12 weeks) will be provided to patients. |
| Treatment group | Experimental | Other: Office-based accommodative/vergence therapyAfter enrollment, patients will be randomized into either treatment group or placebo group. Office-based accommodative/vergence therapy (60 minutes per visit, one time per week, 12 weeks) and home reinforcement (15 minutes each time, five times per week, 12 weeks) will be provided to patients of treatment group. |
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
- monocular accommodation lag at near(33cm)in right eye by non-cycloplegic autorefraction≧1D
Key exclusion criteria (11 listed)
- current or prior use of PALs, bifocals, or contact lenses in either eye( prior or current use of SVLs 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 containing 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 |
|---|---|---|
| Office-based accommodative/vergence therapyOffice-based accommodative/vergence therapy (60 minutes per visit, one time per week, 12 weeks) and home reinforcement (15 minutes each time, five times per week, 12 weeks) | Other | Placebo group, Treatment group |
Primary outcome
the change of Accommodative response is being assessed
Time frame: At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT.
we will use objective measures from open-field auto refractor.
4 secondary outcomes
the changes of Accommodative amplitude is being assessed:
Time frame: At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT.
the changes of Accommodative facility is being assessed:
Time frame: At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT.
the changes of Cycloplegic objective refraction is being assessed:
Time frame: At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT.
the changes of Axial length is being assessed:
Time frame: At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Myopia
Not yet recruiting
The EYERISING Study
Myopia, Astigmatism
RecruitingPhase 3
A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
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
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, PhD 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 Office-based 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 30 Dec 2016. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of Accommodative response is being assessed (time frame: At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT.). 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 30 Dec 2016.