Progressive MyopiaDLTCAMNCT02001415
Efficacy Study of Different Lens Treatments on Chinese Adolescent Myopia
A study testing Spectacles, Myovision and Orthokeratology in people with Progressive Myopia, run by Peking University People's Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine the efficacy of different lens treatments (normal spectacle lens, ortho-K, \& Myovision) on myopia control in Chinese adolescent patients. Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Progressive Myopia
- What is being tested?
- Spectacles, Myovision and Orthokeratology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Nov 2013to 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 10 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Adolescent myopia patients
- Myopic refraction between -1.00D and -4.50D
- Astigmatism equal or less than -1.50D
- Normal break up time of tear film (BUT > 10s)
Who cannot join
- Existence of any ocular diseases except ametropia
- Hyperopia
- Severe dry eye
Trial locations and contacts
1 site in 1 country.
Xi Rong Wu, Dr. contact
China1 site, 1 recruiting
- Recruiting
Ophthalmology Department of Peking University People's Hospital
Beijing, 100044
Kai Wang, Dr., medisaker@gmail.com
Kai Wang, Dr.
About this study
Official title: Randomized Controlled Trial of Different Lens Treatments on Chinese Adolescent Myopia
The purpose of this study is to determine the efficacy of different lens treatments (normal spectacle lens, ortho-K, \& Myovision) on myopia control in Chinese adolescent patients.
Read the detailed description
Different lens treatments include normal spectacle lens, orthokeratology, and Myovision (a specially designed spectacle lens commercially available with peripheral defocus controlled as relative myopia).
This study is to evaluate the efficacy of these three methods in controlling myopia progression. Until now, there is no sufficient clinical evidences to compare different lens treatments.
- Conditions
- Progressive Myopia
- Being tested
- Spectacles, Myovision, Orthokeratology
- Keywords
- Progressive Myopia, Contact Lenses, Spectacles
- Medical subject headings
- Myopia, Degenerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpectaclesOther
Normal spectacle lenses were used to correct myopia as the control group.
MyovisionOther
Myovision is a kind of specially designed spectacle glasses that could control the peripheral refraction of myopia patients. It is commercially available.
OrthokeratologyOther
Orthokeratology lenses.
| Study group | Role | What they receive |
|---|---|---|
| Spectacles | Active comparator | Spectacles are the most common lens treatment to correct myopia. This arm is set to be as a control group for the other two arms. Myopia patients who enter in this group will wear a normal pair of glasses after the baseline examinations (axial length, refraction...). Receives: Other: Spectacles |
| Myovison | Active comparator | Myovision is a kind of specially designed, commercially available spectacle lenses that could control the peripheral refraction of myopia patients. Latest studies have changed the understanding of myopia--correcting both central and peripheral vision during lens treatment is indicating to be an effective way of slowing down eye growth. Patients who entered this group will wear a pair of Myovision after baseline examinations. Receives: Other: Myovision |
| Ortho-K | Active comparator | Orthokeratology has recently been reported as an effective way to control eye growth for myopia adolescents. Patents who enter this group will wear ortho-K lenses during sleep after baseline examinations. Receives: Other: Orthokeratology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Ocular Axial Length
Ocular axial length (AL), which increases with age, will be measured 3 times by an IOLMaster. The first AL examination was considered as the baseline data, and will be repeated 6 and 12 months later.
Measured: Baseline, 6 months, 12 months
Secondary outcomes (1)
Change of Spherical Equivalent Refraction
Spherical Equivalent Refraction (SER), which usually changes from time to time, will be measured 3 times by an open field auto-refractometer. The first SER examination was considered as the baseline data, and will be repeated 6 and 12 months later.
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startNov 2013
- 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 Progressive MyopiaStudies of the same condition, open and under way.
- More trials run by Peking University People's 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kai Wang, Dr., Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001415
- Sponsor's protocol ID
- Z131107002213127
- Acronym
- DLTCAM
- Status last verified
- Apr 2016
- First submitted
- 23 Nov 2013
- Last updated
- 25 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Different Lens Treatments on Chinese Adolescent Myopia
- ClinicalTrials.gov ID
- NCT02001415
- Acronym / sponsor ID
- DLTCAM / Z131107002213127
- Conditions
- Progressive Myopia
- Keywords
- Progressive Myopia, Contact Lenses, Spectacles
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 4 Dec 2013 (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.
The purpose of this study is to determine the efficacy of different lens treatments (normal spectacle lens, ortho-K, \& Myovision) on myopia control in Chinese adolescent patients.
Detailed description
Different lens treatments include normal spectacle lens, orthokeratology, and Myovision (a specially designed spectacle lens commercially available with peripheral defocus controlled as relative myopia).
This study is to evaluate the efficacy of these three methods in controlling myopia progression. Until now, there is no sufficient clinical evidences to compare different lens treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Spectacles | Active comparator | Other: SpectaclesSpectacles are the most common lens treatment to correct myopia. This arm is set to be as a control group for the other two arms. Myopia patients who enter in this group will wear a normal pair of glasses after the baseline examinations (axial length, refraction...). |
| Myovison | Active comparator | Other: MyovisionMyovision is a kind of specially designed, commercially available spectacle lenses that could control the peripheral refraction of myopia patients. Latest studies have changed the understanding of myopia--correcting both central and peripheral vision during lens treatment is indicating to be an effective way of slowing down eye growth. Patients who entered this group will wear a pair of Myovision after baseline examinations. |
| Ortho-K | Active comparator | Other: OrthokeratologyOrthokeratology has recently been reported as an effective way to control eye growth for myopia adolescents. Patents who enter this group will wear ortho-K lenses during sleep after baseline examinations. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Adolescent myopia patients
- Myopic refraction between -1.00D and -4.50D
- Astigmatism equal or less than -1.50D
- Normal break up time of tear film (BUT > 10s)
Key exclusion criteria (3 listed)
- Existence of any ocular diseases except ametropia
- Hyperopia
- Severe dry eye
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 |
|---|---|---|
| SpectaclesNormal spectacle lenses were used to correct myopia as the control group. | Other | Spectacles |
| MyovisionMyovision is a kind of specially designed spectacle glasses that could control the peripheral refraction of myopia patients. It is commercially available. | Other | Myovison |
| OrthokeratologyOrthokeratology lenses. | Other | Ortho-K |
Primary outcome
Change of Ocular Axial Length
Time frame: Baseline, 6 months, 12 months
Ocular axial length (AL), which increases with age, will be measured 3 times by an IOLMaster. The first AL examination was considered as the baseline data, and will be repeated 6 and 12 months later.
1 secondary outcome
Change of Spherical Equivalent Refraction
Time frame: Baseline, 6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2016.
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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.
Xi Rong Wu, Dr. contact
Kai Wang, Dr. principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spectacles, Myovision and Orthokeratology in people with Progressive Myopia, run by Peking University People's 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 4 inclusion and 3 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 25 Apr 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. 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 Kai Wang, Dr. (+86-13810097881, medisaker@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Ocular Axial Length (time frame: Baseline, 6 months, 12 months). 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 25 Apr 2016.