MyopiaNCT05288335
Evaluate the Safety and Efficacy of Two Types of Circular Column Modulated Lenses for Delaying the Progression of Myopia
A study testing Circular cylindrical mirror modulated frame glasses (compact), Circular cylindrical mirror modulated frame glasses (strong defocus) and single vision frame glasses in people with Myopia, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
Clinical trial to evaluate the safety and effectiveness of two kinds of ring band cylindrical lens in delaying the progression of myopia Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Circular cylindrical mirror modulated frame glasses (compact), Circular cylindrical mirror modulated frame glasses (strong defocus) and single vision frame glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 31 Dec 2024
- 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 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 6-13 years old;
- SER: -0.75 to -5.00 dioptres (D). Astigmatism and anisometropia of 1.50 D or less;
- Monocular best corrected visual acuity (VA) of 1.0 or better;
- Acceptance of random group allocation and the masked study design
- Voluntarily participate in the clinical trial and sign the informed consent;
Who cannot join
- Strabismus.
- Ocular and systemic abnormalities.
- Prior experience of myopia control.
- Only one eye meets the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Muti-center Clinical Trial to Evaluate the Safety and Efficacy of Two Types of Circular Column Modulated Lenses for Delaying the Progression of Myopia
Clinical trial to evaluate the safety and effectiveness of two kinds of ring band cylindrical lens in delaying the progression of myopia
Read the detailed description
Two-hundered and forty children aged 6-13 will be recruited and allocated to three groups. Subjects that were randomized to receive Circular cylindrical mirror modulated frame glasses (compact), Circular cylindrical mirror modulated frame glasses (strong defocus) or single vision frame glasses, respectively.
Primary outcome measure ocular axial length and the secondary indicator is spherical equivalent after cycloplegia.
- Conditions
- Myopia
- Being tested
- Circular cylindrical mirror modulated frame glasses (compact), Circular cylindrical mirror modulated frame glasses (strong defocus), single vision frame glasses
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circular cylindrical mirror modulated frame glasses (compact)Device
Circular cylindrical mirror modulated frame glasses (compact)
Circular cylindrical mirror modulated frame glasses (strong defocus)Device
Circular cylindrical mirror modulated frame glasses (strong defocus)
single vision frame glassesDevice
single vision frame glasses
| Study group | Role | What they receive |
|---|---|---|
| Circular cylindrical mirror modulated frame glasses (compact) | Experimental | Subjects that were randomized to receive the Circular cylindrical mirror modulated frame glasses (compact) throughout the entire course of the study. Receives: Device: Circular cylindrical mirror modulated frame glasses (compact) |
| Circular cylindrical mirror modulated frame glasses (strong defocus) | Experimental | Subjects that were randomized to receive the Circular cylindrical mirror modulated frame glasses (strong defocus) throughout the entire course of the study. Receives: Device: Circular cylindrical mirror modulated frame glasses (strong defocus) |
| single vision frame glasses | Experimental | Subjects that were randomized to receive the single vision frame glasses throughout the entire course of the study. Receives: Device: single vision frame glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in ocular axial length in a year
The ocular axial length was measured by AL-scan
Measured: baseline, 12 months
Secondary outcomes (1)
Changes in cycloplegic objective spherical equivalent in a year
The cycloplegic objective spherical equivalent was evaluated by a autorefractor
Measured: baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start1 May 2022
- Primary completion15 Oct 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaoqin Chen, MD, Principal investigator, Tianjin Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288335
- Sponsor's protocol ID
- TianjinEH-myopia progression
- Status last verified
- Jan 2022
- First submitted
- 10 Feb 2022
- Last updated
- 28 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bao J, Yang A, Huang Y, Li X, Pan Y, Ding C, Lim EW, Zheng J, Spiegel DP, Drobe B, Lu F, Chen H. One-year myopia control efficacy of spectacle lenses with aspherical lenslets. Br J Ophthalmol. 2022 Aug;106(8):1171-1176. doi: 10.1136/bjophthalmol-2020-318367. Epub 2021 Apr 2.
PubMed 33811039Muller J, Chen X, Ohlendorf A, Li L, Wahl S. Method comparison and overview of refractive measurements in children: implications for myopia management. BMJ Open Ophthalmol. 2024 Mar 1;9(1):e001322. doi: 10.1136/bmjophth-2023-001322.
PubMed 38429067
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muti-center Clinical Trial to Evaluate the Safety and Efficacy of Two Types of Circular Column Modulated Lenses for Delaying the Progression of Myopia
- ClinicalTrials.gov ID
- NCT05288335
- Acronym / sponsor ID
- TianjinEH-myopia progression
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 15 Oct 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Mar 2022 (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.
Clinical trial to evaluate the safety and effectiveness of two kinds of ring band cylindrical lens in delaying the progression of myopia
Detailed description
Two-hundered and forty children aged 6-13 will be recruited and allocated to three groups. Subjects that were randomized to receive Circular cylindrical mirror modulated frame glasses (compact), Circular cylindrical mirror modulated frame glasses (strong defocus) or single vision frame glasses, respectively.
Primary outcome measure ocular axial length and the secondary indicator is spherical equivalent after cycloplegia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Circular cylindrical mirror modulated frame glasses (compact) | Experimental | Device: Circular cylindrical mirror modulated frame glasses (compact)Subjects that were randomized to receive the Circular cylindrical mirror modulated frame glasses (compact) throughout the entire course of the study. |
| Circular cylindrical mirror modulated frame glasses (strong defocus) | Experimental | Device: Circular cylindrical mirror modulated frame glasses (strong defocus)Subjects that were randomized to receive the Circular cylindrical mirror modulated frame glasses (strong defocus) throughout the entire course of the study. |
| single vision frame glasses | Experimental | Device: single vision frame glassesSubjects that were randomized to receive the single vision frame glasses throughout the entire course of the study. |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 6-13 years old;
- SER: -0.75 to -5.00 dioptres (D). Astigmatism and anisometropia of 1.50 D or less;
- Monocular best corrected visual acuity (VA) of 1.0 or better;
- Acceptance of random group allocation and the masked study design
- Voluntarily participate in the clinical trial and sign the informed consent;
Key exclusion criteria (4 listed)
- Strabismus.
- Ocular and systemic abnormalities.
- Prior experience of myopia control.
- Only one eye meets the inclusion criteria.
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 |
|---|---|---|
| Circular cylindrical mirror modulated frame glasses (compact)Circular cylindrical mirror modulated frame glasses (compact) | Device | Circular cylindrical mirror modulated frame glasses (compact) |
| Circular cylindrical mirror modulated frame glasses (strong defocus)Circular cylindrical mirror modulated frame glasses (strong defocus) | Device | Circular cylindrical mirror modulated frame glasses (strong defocus) |
| single vision frame glassessingle vision frame glasses | Device | single vision frame glasses |
Primary outcome
Changes in ocular axial length in a year
Time frame: baseline, 12 months
The ocular axial length was measured by AL-scan
1 secondary outcome
Changes in cycloplegic objective spherical equivalent in a year
Time frame: baseline, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Background: PubMed 33811039Bao J, Yang A, Huang Y, Li X, Pan Y, Ding C, Lim EW, Zheng J, Spiegel DP, Drobe B, Lu F, Chen H. One-year myopia control efficacy of spectacle lenses with aspherical lenslets. Br J Ophthalmol. 2022 Aug;106(8):1171-1176. doi: 10.1136/bjophthalmol-2020-318367. Epub 2021 Apr 2.
- Derived from this study: PubMed 38429067Muller J, Chen X, Ohlendorf A, Li L, Wahl S. Method comparison and overview of refractive measurements in children: implications for myopia management. BMJ Open Ophthalmol. 2024 Mar 1;9(1):e001322. doi: 10.1136/bmjophth-2023-001322.
- Individual participant dataSharing planned: No
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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.
Xiaoqin Chen, MD principal investigator
Tianjin Eye 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 Circular cylindrical mirror modulated frame glasses (compact), Circular cylindrical mirror modulated frame glasses (strong defocus) and single vision frame glasses in people with Myopia, run by Tianjin Eye 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 4 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 28 Dec 2022. 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?
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?
Changes in ocular axial length in a year (time frame: baseline, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05288335, which also lists 2 linked publications.
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 28 Dec 2022.