Myopia, ProgressiveNCT06221592
Differences and Wearing Safety and Comfort of New Defocus Incorporated Multiple Segments Spectacle Lenses
A study testing defocus spectacle lenses in people with Myopia, Progressive, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
To evaluate the differences in controlling the progression of myopia in adolescents and the safety and comfort of wearing different types of defocus incorporated multiple segments spectacle lenses, to explore the feasibility of effective defocus micro lens design, and apply personalized defocus frame lenses for myopia… Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Myopia, Progressive
- What is being tested?
- defocus spectacle lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 6-14 years old;
- After using 1% cyclohexanone hydrochloride eye drops (Saifeijie) for ciliary muscle paralysis, binocular spherical power were within 0.00D~-4.00D, binocular cylinder power ≤ 1.50D, the anisometropia is less than 1.50D, and the best corrected visual acuity was above 5.0;
- Within 30 days, the myopia prevention and control methods such as multifocal glasses, orthokeratology, defocusing flexible glasses, progressive glasses, atropine eye drops, red light and acupuncture and moxibustion treatment were not used;
- The subject has a willingness to receive treatment and an informed consent form is signed by their legal guardian.
Who cannot join
- Diagnosed constant strabismus;
- Diagnosed pathological myopia;
- Other congenital eye diseases;
- Researchers believe that the patients have other reasons that are not suitable for inclusion in the project.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Eye Diseases Prevention &Treatment Center/ Shanghai Eye Hospital, School of Medicine, Tongji University
Shanghai, Shanghai Municipality, 200050
About this study
Official title: Differences and Wearing Safety and Comfort of New Defocus Incorporated Multiple Segments Spectacle Lenses in Myopia Prevention and Control
To evaluate the differences in controlling the progression of myopia in adolescents and the safety and comfort of wearing different types of defocus incorporated multiple segments spectacle lenses, to explore the feasibility of effective defocus micro lens design, and apply personalized defocus frame lenses for myopia prevention and control.
- Conditions
- Myopia, Progressive
- Being tested
- defocus spectacle lenses
- Medical subject headings
- Myopia, Degenerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
defocus spectacle lensesDevice
To evaluate the differences in controlling the progression of myopia in adolescents and the safety and comfort of wearing different types of defocus incorporated multiple segments spectacle lenses, to explore the feasibility of effective defocus micro lens design, and apply personalized defocus frame lenses for myopia prevention and control.
| Study group | Role | What they receive |
|---|---|---|
| Full axis multi-point defocus spectacle lenses | Experimental | Not described Receives: Device: defocus spectacle lenses |
| Innovative micro defocus spectacle lenses | Experimental | Not described Receives: Device: defocus spectacle lenses |
| Circular multi-point optical micro transparent defocus spectacle lenses | Experimental | Not described Receives: Device: defocus spectacle lenses |
| High non spherical micro transparent defocus spectacle lenses | Placebo comparator | Not described Receives: Device: defocus spectacle lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length
The change of axial length.
Measured: 2 years
Secondary outcomes (1)
Subjective refraction equivalent spherical
The change of Subjective refraction equivalent spherical
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Mar 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia, ProgressiveStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 252 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
- NCT06221592
- Sponsor's protocol ID
- QX-2023-A-03
- Status last verified
- Jan 2024
- First submitted
- 17 Dec 2023
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences and Wearing Safety and Comfort of New Defocus Incorporated Multiple Segments Spectacle Lenses in Myopia Prevention and Control
- ClinicalTrials.gov ID
- NCT06221592
- Acronym / sponsor ID
- QX-2023-A-03
- Conditions
- Myopia, Progressive
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Jan 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.
To evaluate the differences in controlling the progression of myopia in adolescents and the safety and comfort of wearing different types of defocus incorporated multiple segments spectacle lenses, to explore the feasibility of effective defocus micro lens design, and apply personalized defocus frame lenses for myopia prevention and control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Full axis multi-point defocus spectacle lenses | Experimental | Device: defocus spectacle lenses |
| Innovative micro defocus spectacle lenses | Experimental | Device: defocus spectacle lenses |
| Circular multi-point optical micro transparent defocus spectacle lenses | Experimental | Device: defocus spectacle lenses |
| High non spherical micro transparent defocus spectacle lenses | Placebo comparator | Device: defocus spectacle lenses |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age: 6-14 years old;
- After using 1% cyclohexanone hydrochloride eye drops (Saifeijie) for ciliary muscle paralysis, binocular spherical power were within 0.00D~-4.00D, binocular cylinder power ≤ 1.50D, the anisometropia is less than 1.50D, and the best corrected visual acuity was above 5.0;
- Within 30 days, the myopia prevention and control methods such as multifocal glasses, orthokeratology, defocusing flexible glasses, progressive glasses, atropine eye drops, red light and acupuncture and moxibustion treatment were not used;
- The subject has a willingness to receive treatment and an informed consent form is signed by their legal guardian.
Key exclusion criteria (4 listed)
- Diagnosed constant strabismus;
- Diagnosed pathological myopia;
- Other congenital eye diseases;
- Researchers believe that the patients have other reasons that are not suitable for inclusion in the project.
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 |
|---|---|---|
| defocus spectacle lensesTo evaluate the differences in controlling the progression of myopia in adolescents and the safety and comfort of wearing different types of defocus incorporated multiple segments spectacle lenses, to explore the feasibility of effective defocus micro lens design, and apply personalized defocus frame lenses for myopia prevention and control. | Device | Circular multi-point optical micro transparent defocus spectacle lenses, Full axis multi-point defocus spectacle lenses, High non spherical micro transparent defocus spectacle lenses, Innovative micro defocus spectacle lenses |
Primary outcome
Axial length
Time frame: 2 years
The change of axial length.
1 secondary outcome
Subjective refraction equivalent spherical
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing defocus spectacle lenses in people with Myopia, 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 4 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: enrolling by invitation, as of the sponsor's last update on 1 Oct 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Axial length (time frame: 2 years). 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 1 Oct 2024.