MyopiaNCT05340699
Safety and Efficacy of Defocus Distributed Multi-point Lens in Myopia Control
A study testing Defocus Distributed Multi-point lens and Single vision lens in people with Myopia, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
Evaluate the safety and effectiveness of experimental group by comparing with the control group 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?
- Defocus Distributed Multi-point lens and Single vision lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 20 May 2023
- 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
- Aged 6-13,with written consent of his/her guardian,regardless of gender;
- Objective cycloplegic spherical equivalent refractive between -1.00D and 5.00D,and best corrected vision acuity of right and left eyes are better than or equal to 1.0;
- Astigmatism less than or equal to -1.50D;
- Voluntarily participate in the clinical trial and sign the informed consent.
Who cannot join
- Those with a history of ocular trauma or intraocular surgery;
- Clinical significant slit-lamp findings;
- Abnormal IOP(<10 mmHg , >21 mmHg or difference between two eyes >5mmHg);
- Patient with other eye diseases,such as uveitis and other inflammation,glaucoma,cataract,fundus disease,eye tumors,eye trauma,strabismus and any lesions that affect vision function;
- Patient with systemic diseases causing immunosuppression,such as acute or chronic sinusitis,diabetes,Down syndrome,rheumatoid arthritis,psychosis and other conditions that the investigator considers inappropriate for wearing glasses;
- Those who have participated in other drug clinical trials within 3 months;
Show all 10Show fewer
- Only one eye meets the inclusion criteria;
- Those who cannot have regular eye examinations;
- Those who have been involved in any myopia control clinical trials,previously used or are using RGP,contact lens and glasses or atropine drugs to control myopia in the past year;
- The candidates determined by the investigator are not eligible.
Trial locations and contacts
1 site in 1 country.
About this study
Evaluate the safety and effectiveness of experimental group by comparing with the control group
Read the detailed description
Compared the experimental group with the control group,the safety and effectiveness of DDM lens in mtopia control will be evaluated.
- Conditions
- Myopia
- Being tested
- Defocus Distributed Multi-point lens, Single vision lens
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Defocus Distributed Multi-point lensDevice
Wear DDM lens
Single vision lensDevice
Wear single vision lens
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | A group of children wearing Xingyouxue Defocus Distributed Multi-point lens Receives: Device: Defocus Distributed Multi-point lens |
| control group | Active comparator | A group of children wearing single vision lens Receives: Device: Single vision lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Objective cycloplegic refractive
Changes in objective cycloplegic refractive from baseline between two groups
Measured: baseline, 12 months
Changes in Axial Length
Changes in axial length from baseline between two groups
Measured: baseline, 12 months
Secondary outcomes (4)
Changes in Objective cycloplegic refractive
Changes in objective cycloplegic refractive from baseline between two groups
Measured: baseline, 6 months，18 months and 24 months
Changes in Axial length
Changes in axial length from baseline between two groups
Measured: baseline, 6 months，18 months and 24 months
Changes in amplitude of accommodation
Changes in amplitude of accommodation between two groups evey 6 months
Measured: baseline, 6 months，18 months and 24 months
Changes in near point of convergence
Changes in near point of convergence between two groups evey 6 months
Measured: baseline, 6 months，18 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 May 2022
- Primary completion20 Feb 2023 (estimated)
- Study completion20 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 168 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, Tianjin,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340699
- Sponsor's protocol ID
- KY202003
- Status last verified
- Mar 2022
- First submitted
- 22 Mar 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen X, Li M, Li J, Wu M, Liu X, Yu C, Guo X, Wang Y, Wang Y, Lu W, Li L, Wang Y. One-year efficacy of myopia control by the defocus distributed multipoint lens: a multicentric randomised controlled trial. Br J Ophthalmol. 2024 Oct 22;108(11):1583-1589. doi: 10.1136/bjo-2023-324243.
PubMed 38503477
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Defocus Distributed Multi-point Lens in Myopia Control
- ClinicalTrials.gov ID
- NCT05340699
- Acronym / sponsor ID
- KY202003
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 20 Feb 2023 (estimated)
- Study completion
- 20 May 2023 (estimated)
- First posted
- 22 Apr 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.
Evaluate the safety and effectiveness of experimental group by comparing with the control group
Detailed description
Compared the experimental group with the control group,the safety and effectiveness of DDM lens in mtopia control will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Device: Defocus Distributed Multi-point lensA group of children wearing Xingyouxue Defocus Distributed Multi-point lens |
| control group | Active comparator | Device: Single vision lensA group of children wearing single vision lens |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged 6-13,with written consent of his/her guardian,regardless of gender;
- Objective cycloplegic spherical equivalent refractive between -1.00D and 5.00D,and best corrected vision acuity of right and left eyes are better than or equal to 1.0;
- Astigmatism less than or equal to -1.50D;
- Voluntarily participate in the clinical trial and sign the informed consent.
Key exclusion criteria (10 listed)
- Those with a history of ocular trauma or intraocular surgery;
- Clinical significant slit-lamp findings;
- Abnormal IOP(<10 mmHg , >21 mmHg or difference between two eyes >5mmHg);
- Patient with other eye diseases,such as uveitis and other inflammation,glaucoma,cataract,fundus disease,eye tumors,eye trauma,strabismus and any lesions that affect vision function;
- Patient with systemic diseases causing immunosuppression,such as acute or chronic sinusitis,diabetes,Down syndrome,rheumatoid arthritis,psychosis and other conditions that the investigator considers inappropriate for wearing glasses;
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 Distributed Multi-point lensWear DDM lens | Device | experimental group |
| Single vision lensWear single vision lens | Device | control group |
Primary outcome
Changes in Objective cycloplegic refractive
Time frame: baseline, 12 months
Changes in objective cycloplegic refractive from baseline between two groups
Changes in Axial Length
Time frame: baseline, 12 months
Changes in axial length from baseline between two groups
4 secondary outcomes
Changes in Objective cycloplegic refractive
Time frame: baseline, 6 months，18 months and 24 months
Changes in Axial length
Time frame: baseline, 6 months，18 months and 24 months
Changes in amplitude of accommodation
Time frame: baseline, 6 months，18 months and 24 months
Changes in near point of convergence
Time frame: baseline, 6 months，18 months and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Derived from this study: PubMed 38503477Chen X, Li M, Li J, Wu M, Liu X, Yu C, Guo X, Wang Y, Wang Y, Lu W, Li L, Wang Y. One-year efficacy of myopia control by the defocus distributed multipoint lens: a multicentric randomised controlled trial. Br J Ophthalmol. 2024 Oct 22;108(11):1583-1589. doi: 10.1136/bjo-2023-324243.
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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, Tianjin,China
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 Distributed Multi-point lens and Single vision lens 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 4 inclusion and 10 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 7 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 Objective cycloplegic refractive (time frame: baseline, 12 months). The study lists 2 primary outcomes in all. 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 NCT05340699, which also lists 1 linked publication.
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 7 Dec 2022.