Myopia, ProgressiveNCT05300321
DIMS-myopia Progression ADN Axial Length Growth
A study testing frame lens in people with Myopia, Progressive, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
To confirm the efficacy of DIMS lenses in controlling myopia progression, we planned a prospective randomized controlled clinical study. Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Progressive
- What is being tested?
- frame lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 1 Apr 2021
- 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
- The subjects had spherical RE of -1.00 to -6.50 D, astigmatism ≤ 4.00 D, anisometropia ≤ 1.50 D
- Best corrected visual acuity (BCVA) equal to or better than logMAR 0.0 (20/20) in both eyes.
Who cannot join
- Candidate subjects were excluded from the study if they had strabismus, ocular limitations, or systemic abnormalities affecting vision and ocular motility.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Defocus Incorporated Multiple Segments (DIMS) Lens Chinese Myopic Children
To confirm the efficacy of DIMS lenses in controlling myopia progression, we planned a prospective randomized controlled clinical study.
Read the detailed description
The subjects were randomly assigned into two groups: the control group (SV) and the experimental group (DIMS). The clinical trial assistant took the glasses before examination and returned them after examiners had performed all tests. Examiners were unaware of the spectacle type until the end of the follow-up period. However, the lens type was known by children and parents since the unique appearance of the DIMS lens.
The subjects were provided details about the study design and methodology and their rights as subjects at first visit. We conducted visual acuity tests, subjective and objective refraction measurements, AL measurements, heterophoria at distance and near, and accommodation after obtaining written informed consent from them and their parent.
We conducted follow-up examinations 6 and 12 months after the first visit. In the follow-up examinations, we measured all the examination as do ate the firt visit.
Either the VA with the current spectacles dropped to < 0.8(20/20) or SE of cycloplegic subjective refraction increased ≤-0.50D, the lens power of the spectacles was replaced on the basis of the cycloplegic subjective refraction.
- Conditions
- Myopia, Progressive
- Being tested
- frame lens
- Keywords
- myopia, axial length, DIMS
- Medical subject headings
- Myopia, Degenerative, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
frame lensDevice
The subjects were randomized to allocate in Single Vision (SV) lens or Defocus Incorporated Multiple Segments (DIMS) Lens group.
| Study group | Role | What they receive |
|---|---|---|
| Single Vision Lens | Experimental | The sunbjects were randomized to allocate in single vision lens group. Receives: Device: frame lens |
| Defocus Incorporated Multiple Segments (DIMS) Lens | Experimental | The sunbjects were randomized to allocate in Defocus Incorporated Multiple Segments (DIMS) Lens group. Receives: Device: frame lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cycloplegic objective refraction
Cycloplegic objective refraction was measured with an autorefractor (Topcon KR8900, Japan).
Measured: 12months
Secondary outcomes (1)
Axial Length
Axial length (AL) was measured with an AL-Scan optical biometer (Nidek, Japan).
Measured: 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start1 Jun 2019
- Primary completion30 Nov 2020
- Study completion1 Apr 2021
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 82 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
- NCT05300321
- Sponsor's protocol ID
- KY201902
- Status last verified
- Mar 2022
- First submitted
- 18 Mar 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- 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 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Defocus Incorporated Multiple Segments (DIMS) Lens Chinese Myopic Children
- ClinicalTrials.gov ID
- NCT05300321
- Acronym / sponsor ID
- KY201902
- Conditions
- Myopia, Progressive
- Keywords
- myopia, axial length, DIMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 29 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.
To confirm the efficacy of DIMS lenses in controlling myopia progression, we planned a prospective randomized controlled clinical study.
Detailed description
The subjects were randomly assigned into two groups: the control group (SV) and the experimental group (DIMS). The clinical trial assistant took the glasses before examination and returned them after examiners had performed all tests. Examiners were unaware of the spectacle type until the end of the follow-up period. However, the lens type was known by children and parents since the unique appearance of the DIMS lens.
The subjects were provided details about the study design and methodology and their rights as subjects at first visit. We conducted visual acuity tests, subjective and objective refraction measurements, AL measurements, heterophoria at distance and near, and accommodation after obtaining written informed consent from them and their parent.
We conducted follow-up examinations 6 and 12 months after the first visit. In the follow-up examinations, we measured all the examination as do ate the firt visit.
Either the VA with the current spectacles dropped to < 0.8(20/20) or SE of cycloplegic subjective refraction increased ≤-0.50D, the lens power of the spectacles was replaced on the basis of the cycloplegic subjective refraction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Vision Lens | Experimental | Device: frame lensThe sunbjects were randomized to allocate in single vision lens group. |
| Defocus Incorporated Multiple Segments (DIMS) Lens | Experimental | Device: frame lensThe sunbjects were randomized to allocate in Defocus Incorporated Multiple Segments (DIMS) Lens group. |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- The subjects had spherical RE of -1.00 to -6.50 D, astigmatism ≤ 4.00 D, anisometropia ≤ 1.50 D
- Best corrected visual acuity (BCVA) equal to or better than logMAR 0.0 (20/20) in both eyes.
Key exclusion criteria (1 listed)
- Candidate subjects were excluded from the study if they had strabismus, ocular limitations, or systemic abnormalities affecting vision and ocular motility.
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 |
|---|---|---|
| frame lensThe subjects were randomized to allocate in Single Vision (SV) lens or Defocus Incorporated Multiple Segments (DIMS) Lens group. | Device | Defocus Incorporated Multiple Segments (DIMS) Lens, Single Vision Lens |
Primary outcome
Cycloplegic objective refraction
Time frame: 12months
Cycloplegic objective refraction was measured with an autorefractor (Topcon KR8900, Japan).
1 secondary outcome
Axial Length
Time frame: 12months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- 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 frame lens in people with Myopia, Progressive, 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 25 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cycloplegic objective refraction (time frame: 12months). 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 2022; AzTrials last refreshed its copy on 26 Oct 2026.