Juvenile MyopiaCATHAYNCT05562622
Assessment of DOT Spectacles in Chinese Children
A study testing Novel spectacle lens design and Spectacle lenses in people with Juvenile Myopia and Myopia, run by SightGlass Vision, Inc. at 5 sites in China.
Trial summary
This is a randomized, controlled, evaluator-blinded, multicenter, two-arm parallel group clinical trial to evaluate the continued safety and efficacy of Diffusion Optics Technology (DOT) spectacle lenses by comparing to single vision, impact-resistant spectacle lenses in reducing the progression of myopia in children… Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Juvenile Myopia, Myopia
- What is being tested?
- Novel spectacle lens design and Spectacle lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 5 sitesChina
- Study dates
- 5 Feb 2023to 31 Dec 2027
- 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 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children 6-13 years of age
- SER error between -0.75D and -5.00D
- Willingness to wear study spectacles and participate in the trial for 12 months without contact lens wear
Who cannot join
- Prior usage of atropine, multifocal contact lenses, or orthokeratology (ortho-K)
- Astigmatism worse than -1.50 DC (by manifest refraction) in either eye
- Anisometropia (SER manifest refraction) greater than 1.00 D
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Aier Eye Hospital
Changsha
West China Hospital
Chengdu
Zhongshan Ophthalmic Center
Guangzhou
Fudan University EENT
Shanghai
Tianjin Eye Hospital
Tianjin
About this study
Official title: Clinical Assessment of DOT Spectacle Lenses in Chinese Children
This is a randomized, controlled, evaluator-blinded, multicenter, two-arm parallel group clinical trial to evaluate the continued safety and efficacy of Diffusion Optics Technology (DOT) spectacle lenses by comparing to single vision, impact-resistant spectacle lenses in reducing the progression of myopia in children of Chinese origin.
- Conditions
- Juvenile Myopia, Myopia
- Being tested
- Novel spectacle lens design, Spectacle lenses
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel spectacle lens designDevice
Use of lenses may reduce the rate of progression of juvenile myopia
Spectacle lensesDevice
Use of lenses may reduce the rate of progression of juvenile myopia
| Study group | Role | What they receive |
|---|---|---|
| SightGlass Vision Test Arm 1 | Experimental | Single vision, impact-resistant spectacle lenses Receives: Device: Novel spectacle lens design |
| Test Arm 2 | Other | Single vision, impact-resistant spectacle lenses Receives: Device: Spectacle lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length
Change in axial length from baseline
Measured: 12 months
Secondary outcomes (2)
Axial length
Change in axial length from baseline
Measured: 24 months
Axial length
Change in axial length from baseline
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start5 Feb 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile MyopiaStudies of the same condition, open and under way.
- More trials run by SightGlass Vision, Inc.The sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- SightGlass Vision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562622
- Sponsor's protocol ID
- CPRO-2201-001
- Acronym
- CATHAY
- Status last verified
- Jul 2026
- First submitted
- 28 Sep 2022
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of DOT Spectacle Lenses in Chinese Children
- ClinicalTrials.gov ID
- NCT05562622
- Acronym / sponsor ID
- CATHAY / CPRO-2201-001
- Conditions
- Juvenile Myopia, Myopia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 195 participants (actual)
- Lead sponsor
- SightGlass Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Feb 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Oct 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.
This is a randomized, controlled, evaluator-blinded, multicenter, two-arm parallel group clinical trial to evaluate the continued safety and efficacy of Diffusion Optics Technology (DOT) spectacle lenses by comparing to single vision, impact-resistant spectacle lenses in reducing the progression of myopia in children of Chinese origin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SightGlass Vision Test Arm 1 | Experimental | Device: Novel spectacle lens designSingle vision, impact-resistant spectacle lenses |
| Test Arm 2 | Other | Device: Spectacle lensesSingle vision, impact-resistant spectacle lenses |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children 6-13 years of age
- SER error between -0.75D and -5.00D
- Willingness to wear study spectacles and participate in the trial for 12 months without contact lens wear
Key exclusion criteria (3 listed)
- Prior usage of atropine, multifocal contact lenses, or orthokeratology (ortho-K)
- Astigmatism worse than -1.50 DC (by manifest refraction) in either eye
- Anisometropia (SER manifest refraction) greater than 1.00 D
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 |
|---|---|---|
| Novel spectacle lens designUse of lenses may reduce the rate of progression of juvenile myopia | Device | SightGlass Vision Test Arm 1 |
| Spectacle lensesUse of lenses may reduce the rate of progression of juvenile myopia | Device | Test Arm 2 |
Primary outcome
Axial length
Time frame: 12 months
Change in axial length from baseline
2 secondary outcomes
Axial length
Time frame: 24 months
Axial length
Time frame: 36 months
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 13 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel spectacle lens design and Spectacle lenses in people with Juvenile Myopia and Myopia, run by SightGlass Vision, Inc. at 5 sites 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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
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: 12 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 13 Jul 2026.