MyopiaPhase 4NCT02186184
Effect of Orthokeratology Versus Spectacles on Myopia Progression in Chinese Children: A Crossover Trial
A Phase 4 study testing Orthokeratology and Spectacle in people with Myopia, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
Orthokeratology is becoming popular for the treatment of myopia children. Many studies have shown that orthokeratology is effective in temporarily reducing refractive error, and is also helpful for controlling myopia progression. Read more about this study
- Who is it for?
- Ages 7 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Orthokeratology and Spectacle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Oct 2017
- Phase
- Phase 4
- 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 7 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Ages Eligible for Study: 7 Years to 14 Years
- Genders Eligible for Study: Both
- Visual acuity 20/20 or better in each eye
- Spherical error ranging from -0.5 D to -5.0 D and astigmatism less than 1.5 D in each eye, anisometropia less than 1.0 D between the two eyes
- No strabismus, amblyopia and any other ocular or systematic diseases that may affect refractive development
Who cannot join
- Currently or history using other interventions to control myopia progression (acupuncture, drugs, contact lens, ear needles and so on)
- Unable to cooperate with the ocular examination,questionnaire survey,or orthokeratology wearing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Orthokeratology on Myopia Progression in Chinese Children
Orthokeratology is becoming popular for the treatment of myopia children. Many studies have shown that orthokeratology is effective in temporarily reducing refractive error, and is also helpful for controlling myopia progression. However, the mechanism for its slowing myopia progression and rebound effect after the treatment have not been clearly studied. In addition, the effect of orthokeratology among Chinese children has not been evaluated with randomized controlled trial.This study is to assess the effect of orthokeratology versus spectacles on myopia progression in school-aged Chinese children during two years.
- Conditions
- Myopia
- Being tested
- Orthokeratology, Spectacle
- Keywords
- Myopia progression, Orthokeratology
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrthokeratologyDevice
SpectacleDevice
Also called Glasses
| Study group | Role | What they receive |
|---|---|---|
| Orthokeratology in the first year | Experimental | The participants would wear orthokeratology in the first year and then switch to spectacle in the second year Receives: Device: Orthokeratology; Device: Spectacle |
| Spectacle in the first year | Active comparator | The participants would wear spectacle in the first year and then changed to orthokeratology in the second year Receives: Device: Orthokeratology; Device: Spectacle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refraction
The participants will be measured for their cycloplegic central refractive error before and after wearing the orthokeratology. Peripheral refraction will also be measured by WAM-5500.
Measured: Change from baseline at 1 year
Axial length
The Lenstar will be used to measure the axial length.
Measured: Change from baseline at 1 year
Refraction
Measured: Change from baseline at 2 years
Axial length
Measured: Change from baseline at 2 years
Secondary outcomes (6)
Tear film break up time(BUT)
Measured: Change from baseline at 1 year
Self evaluation of comfortableness
Measured: Change from baseline at 1 year
Corneal endothelial cell density
Measured: Change from baseline at 1 year
Tear film break up time(BUT)
Measured: Change from baseline at 2 years
Self evaluation of comfortness
Measured: Change from baseline at 2 years
Corneal endothelial cell density
Measured: Change from baseline at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2017
- Study completionOct 2017
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 Beijing Tongren HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi-Ming Li, Beijing Tongren Hospital
- Investigators
- Ningli Wang, MD,PhD, Principal investigator, Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186184
- Sponsor's protocol ID
- 2014CB504601
- Status last verified
- Dec 2017
- First submitted
- 29 Jun 2014
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Orthokeratology on Myopia Progression in Chinese Children
- ClinicalTrials.gov ID
- NCT02186184
- Acronym / sponsor ID
- 2014CB504601
- Conditions
- Myopia
- Keywords
- Myopia progression, Orthokeratology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 10 Jul 2014 (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.
Orthokeratology is becoming popular for the treatment of myopia children. Many studies have shown that orthokeratology is effective in temporarily reducing refractive error, and is also helpful for controlling myopia progression. However, the mechanism for its slowing myopia progression and rebound effect after the treatment have not been clearly studied. In addition, the effect of orthokeratology among Chinese children has not been evaluated with randomized controlled trial.This study is to assess the effect of orthokeratology versus spectacles on myopia progression in school-aged Chinese children during two years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orthokeratology in the first year | Experimental | Device: Orthokeratology, Device: SpectacleThe participants would wear orthokeratology in the first year and then switch to spectacle in the second year |
| Spectacle in the first year | Active comparator | Device: Orthokeratology, Device: SpectacleThe participants would wear spectacle in the first year and then changed to orthokeratology in the second year |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Ages Eligible for Study: 7 Years to 14 Years
- Genders Eligible for Study: Both
- Visual acuity 20/20 or better in each eye
- Spherical error ranging from -0.5 D to -5.0 D and astigmatism less than 1.5 D in each eye, anisometropia less than 1.0 D between the two eyes
- No strabismus, amblyopia and any other ocular or systematic diseases that may affect refractive development
Key exclusion criteria (2 listed)
- Currently or history using other interventions to control myopia progression (acupuncture, drugs, contact lens, ear needles and so on)
- Unable to cooperate with the ocular examination,questionnaire survey,or orthokeratology wearing
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 |
|---|---|---|
| Orthokeratology | Device | Orthokeratology in the first year, Spectacle in the first year |
| SpectacleAlso: Glasses | Device | Orthokeratology in the first year, Spectacle in the first year |
Primary outcome
Refraction
Time frame: Change from baseline at 1 year
The participants will be measured for their cycloplegic central refractive error before and after wearing the orthokeratology. Peripheral refraction will also be measured by WAM-5500.
Axial length
Time frame: Change from baseline at 1 year
The Lenstar will be used to measure the axial length.
Refraction
Time frame: Change from baseline at 2 years
Axial length
Time frame: Change from baseline at 2 years
6 secondary outcomes
Tear film break up time(BUT)
Time frame: Change from baseline at 1 year
Self evaluation of comfortableness
Time frame: Change from baseline at 1 year
Corneal endothelial cell density
Time frame: Change from baseline at 1 year
Tear film break up time(BUT)
Time frame: Change from baseline at 2 years
Self evaluation of comfortness
Time frame: Change from baseline at 2 years
Corneal endothelial cell density
Time frame: Change from baseline at 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
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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.
Ningli Wang, MD,PhD principal investigator
Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Orthokeratology and Spectacle in people with Myopia, run by Beijing Tongren Hospital 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 19 Dec 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Refraction (time frame: Change from baseline at 1 year). The study lists 4 primary outcomes in all. 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 Dec 2017.