MyopiaNCT06329986
Crossover RCT of TAMER Lenses in Myopia Control
A study testing TAMER Lens Spectacle and SV lenses in people with Myopia and Progressive, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
This study is a prospective, randomized, crossover clinical trial with a planned proposed enrollment of 120 Chinese male and female subjects aged 6-12 years without systemic or ocular diseases to follow up their cycloplegic equivalent spherical lens power and other relevant indices in order to determine the role of… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Myopia, Progressive
- What is being tested?
- TAMER Lens Spectacle and SV lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 24 Feb 2024to Jan 2026
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Race: Chinese children and adolescents.
- Age 6-12 years, gender unrestricted.
- Cycloplegic refraction SER: -0.75DS~-5.0DS in both eyes.
- Best corrected visual acuity of both eyes reaches 0.8 (0.00 logMAR).
- Cylinder power and astigmatism are no more than 1.5D.
- During the study period, willing to wear glasses provided by the researcher only and without additional interventions.
- Willing to be randomly assigned.
- Able to sign an informed consent form with the accompaniment and understanding of parents or guardians.
Who cannot join
- Allergic or intolerant to medications used for cycloplegia.
- Received any nearsightedness treatment such as atropine, rigid gas permeable contact lens, bifocal/progressive lens, red light therapy, or acupuncture within half a year before the study.
- Diagnosed with any eye disease other than nearsightedness, including strabismus, corneal diseases, conjunctival or eyelid damage or other conditions (such as keratoconus, herpes simplex keratitis, etc.).
- History of eye surgery (including strabismus correction surgery).
- Eye or systemic diseases that might be associated with nearsightedness or its progression, such as Marfan syndrome, retinopathy of prematurity, diabetes, etc.
- Anatomical or dermatological factors that may interfere with the wearing of spectacle frames.
- Other reasons that the researcher deems inappropriate for the participant to be included in the study, such as excessively high expectations for the effectiveness of defocus lenses, or plans to use other nearsightedness intervention strategies simultaneously with the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Eye Disease Prevention and Treatment Center
Shanghai, Shanghai Municipality, 200041
Xiangui He, 021-62982727-817
About this study
Official title: A Randomized, Crossover Controlled Trial of the Effect of TAMER Lenses Versus Single Vision Lenses on Myopic Progression in Myopic Children
This study is a prospective, randomized, crossover clinical trial with a planned proposed enrollment of 120 Chinese male and female subjects aged 6-12 years without systemic or ocular diseases to follow up their cycloplegic equivalent spherical lens power and other relevant indices in order to determine the role of TAMER lenses in myopia control as compared to singlie vision lenses.
- Conditions
- Myopia, Progressive
- Being tested
- TAMER Lens Spectacle, SV lenses
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAMER Lens SpectacleDevice
Regular daily wear of TAMER lens spectacle
SV lensesDevice
SV lenses
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | TAMER lenses are used first for 6 months, followed by SV lenses for 6 months. Receives: Device: TAMER Lens Spectacle; Device: SV lenses |
| Group B | Experimental | SV lenses are used first for 6 months, followed by TAMER lenses for 6 months. Receives: Device: TAMER Lens Spectacle; Device: SV lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spherical Equivalent change
cycloplegic SE change
Measured: 6 months
Secondary outcomes (2)
Axial Length change
Measured: 6 months
Spherical Equivalent change
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start24 Feb 2024
- Primary completionJun 2025 (estimated)
- Study completionJan 2026 (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.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329986
- Sponsor's protocol ID
- SEDPTC20240109
- Status last verified
- Jan 2024
- First submitted
- 1 Feb 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Crossover Controlled Trial of the Effect of TAMER Lenses Versus Single Vision Lenses on Myopic Progression in Myopic Children
- ClinicalTrials.gov ID
- NCT06329986
- Acronym / sponsor ID
- SEDPTC20240109
- Conditions
- Myopia, Progressive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 24 Feb 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 26 Mar 2024 (actual)
- 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 is a prospective, randomized, crossover clinical trial with a planned proposed enrollment of 120 Chinese male and female subjects aged 6-12 years without systemic or ocular diseases to follow up their cycloplegic equivalent spherical lens power and other relevant indices in order to determine the role of TAMER lenses in myopia control as compared to singlie vision lenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: TAMER Lens Spectacle, Device: SV lensesTAMER lenses are used first for 6 months, followed by SV lenses for 6 months. |
| Group B | Experimental | Device: TAMER Lens Spectacle, Device: SV lensesSV lenses are used first for 6 months, followed by TAMER lenses for 6 months. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Race: Chinese children and adolescents.
- Age 6-12 years, gender unrestricted.
- Cycloplegic refraction SER: -0.75DS~-5.0DS in both eyes.
- Best corrected visual acuity of both eyes reaches 0.8 (0.00 logMAR).
- Cylinder power and astigmatism are no more than 1.5D.
Key exclusion criteria (7 listed)
- Allergic or intolerant to medications used for cycloplegia.
- Received any nearsightedness treatment such as atropine, rigid gas permeable contact lens, bifocal/progressive lens, red light therapy, or acupuncture within half a year before the study.
- Diagnosed with any eye disease other than nearsightedness, including strabismus, corneal diseases, conjunctival or eyelid damage or other conditions (such as keratoconus, herpes simplex keratitis, etc.).
- History of eye surgery (including strabismus correction surgery).
- Eye or systemic diseases that might be associated with nearsightedness or its progression, such as Marfan syndrome, retinopathy of prematurity, diabetes, etc.
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 |
|---|---|---|
| TAMER Lens SpectacleRegular daily wear of TAMER lens spectacle | Device | Group A, Group B |
| SV lensesSV lenses | Device | Group A, Group B |
Primary outcome
Spherical Equivalent change
Time frame: 6 months
cycloplegic SE change
2 secondary outcomes
Axial Length change
Time frame: 6 months
Spherical Equivalent change
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAMER Lens Spectacle and SV lenses in people with Myopia and Progressive, run by Shanghai Eye Disease Prevention and Treatment Center 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 8 inclusion and 7 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 26 Mar 2024. 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 Xiangui He (021-62982727-817, dllcrco@shsyf.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spherical Equivalent change (time frame: 6 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 26 Mar 2024.