Juvenile MyopiaCATHAY ExtNCT07008001
Assessment of DOT Spectacles in Chinese Children Extension
A study testing Novel spectacle lens design in people with Juvenile Myopia and Myopia, run by SightGlass Vision, Inc. at 5 sites in China.
Trial summary
This is a randomized, controlled, open-label, evaluator-blinded, multicenter, clinical trial of 12-months duration to evaluate the continued safety and efficacy of Diffusion Optics Technology (DOT) spectacle lenses in reducing the progression of juvenile myopia in children of Chinese origin. Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Juvenile Myopia, Myopia
- What is being tested?
- Novel spectacle lens design
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 5 sitesChina
- Study dates
- 1 Aug 2025to 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 8 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Previously a successfully completed participant in the CATHAY study (NCT05562622)
- Agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day)
- Willingness to participate in the trial for 12 months without contact lens wear or any other myopia management intervention
- The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form
Who cannot join
- 1. Known allergy to proparacaine, tetracaine, or tropicamide or cyclopentolate
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Aier Eye Hospital
Changsha
Xiaoning Li
Xiaoning Li
- Recruiting
West China Hospital
Chengdu
Longqian Liu
Longqian Liu
- Not yet recruiting
Zhongshan Ophthalmic Center
Guangzhou
Xiao Yang
Xiao Yang
- Recruiting
Fudan University EENT
Shanghai
Peter Chen
Peter Chen
- Recruiting
Tianjin Eye Hospital
Tianjin
Lihua Li
Lihua Li
About this study
Official title: Clinical Assessment of DOT Spectacle Lenses in Chinese Children Extension
This is a randomized, controlled, open-label, evaluator-blinded, multicenter, clinical trial of 12-months duration to evaluate the continued safety and efficacy of Diffusion Optics Technology (DOT) spectacle lenses in reducing the progression of juvenile myopia in children of Chinese origin.
- Conditions
- Juvenile Myopia, Myopia
- Being tested
- Novel spectacle lens design
- 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 spectacle lenses may reduce the rate of progression of juvenile myopia
| Study group | Role | What they receive |
|---|---|---|
| SightGlass Vision Test Arm Groups I (formerly test group) | Experimental | Single vision, impact-resistant spectacle lenses Receives: Device: Novel spectacle lens design |
| SightGlass Vision Test Arm Groups II (formerly control group) | Experimental | Single vision, impact-resistant spectacle lenses Receives: Device: Novel spectacle lens design |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length Group I
Change in axial length from baseline to 36 months
Measured: 12 months
Axial length Group II
Change in axial length from baseline to 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start1 Aug 2025
- Primary completion30 Sep 2026 (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 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
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SightGlass Vision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008001
- Sponsor's protocol ID
- CPRO-2201-002
- Acronym
- CATHAY Ext
- Status last verified
- Dec 2025
- First submitted
- 14 May 2025
- Last updated
- 29 Dec 2025
- 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 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of DOT Spectacle Lenses in Chinese Children Extension
- ClinicalTrials.gov ID
- NCT07008001
- Acronym / sponsor ID
- CATHAY Ext / CPRO-2201-002
- Conditions
- Juvenile Myopia, Myopia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- SightGlass Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Jun 2025 (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, open-label, evaluator-blinded, multicenter, clinical trial of 12-months duration to evaluate the continued safety and efficacy of Diffusion Optics Technology (DOT) spectacle lenses in reducing the progression of juvenile 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 Groups I (formerly test group) | Experimental | Device: Novel spectacle lens designSingle vision, impact-resistant spectacle lenses |
| SightGlass Vision Test Arm Groups II (formerly control group) | Experimental | Device: Novel spectacle lens designSingle vision, impact-resistant spectacle lenses |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Previously a successfully completed participant in the CATHAY study (NCT05562622)
- Agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day)
- Willingness to participate in the trial for 12 months without contact lens wear or any other myopia management intervention
- The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form
Key exclusion criteria (1 listed)
- 1. Known allergy to proparacaine, tetracaine, or tropicamide or cyclopentolate
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 spectacle lenses may reduce the rate of progression of juvenile myopia | Device | SightGlass Vision Test Arm Groups I (formerly test group), SightGlass Vision Test Arm Groups II (formerly control group) |
Primary outcome
Axial length Group I
Time frame: 12 months
Change in axial length from baseline to 36 months
Axial length Group II
Time frame: 12 months
Change in axial length from baseline to 12 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 29 Dec 2025.
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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.
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 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 4 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: looking for participants now, as of the sponsor's last update on 29 Dec 2025. 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?
Contact Jennifer S Hill, BS (678-361-4877, jhill@sightglassvision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial length Group I (time frame: 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?
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 29 Dec 2025.