MyopiaASH-2NCT05617794
Effect of Diffusion Optics Technology (DOT) Spectacle Lenses on Choroidal Thickness
A study testing Diffusion Optics Technology (DOT) Pattern Spectacle Lens in people with Myopia and Myopia Progression, run by SightGlass Vision, Inc. at 1 site in Canada.
Trial summary
The objective of the study is to measure the effect of Diffusion Optics Technology (DOT) spectacle lenses on the choroidal thickness and choroidal vascularity index compared to control lenses. Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Myopia Progression, Juvenile Myopia
- What is being tested?
- Diffusion Optics Technology (DOT) Pattern Spectacle Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 18 Jan 2023to 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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Are 8-14 years of age;
- Are able to read (or be read to), understand and sign the assent document;
- Are accompanied by a parent or legal guardian who is able to read, understand and sign the parental information and permission document;
- Are emmetropic by non-cycloplegic auto-refraction, which means both refractive meridians should be within +1.00D and -1.00D inclusively;
- Are willing and able to follow instructions.
Who cannot join
- Are participating in any concurrent interventional clinical or research study;
- Have a history of myopia control treatment in the past year;
- Have amblyopia in either eye or known to have any other binocular vision disorder, such as accommodative insufficiency;
- Have any known active ocular disease and/or infection;
- Have a systemic condition that in the opinion of the investigator may affect a study outcome variable. Examples include diabetes mellitus, hyperthyroidism;
- Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable. Examples include Atropine eye drops;
- Have undergone strabismus surgery, refractive error surgery or intraocular surgery;
- Are a child of a member of the study team.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Ocular Research and Education
Waterloo, Ontario, N2L 3G1
About this study
Official title: Effect of Diffusion Optics Technology (DOT) Spectacle Lenses on Choroidal Thickness and Choroidal Vascularity Index in Emmetropes
The objective of the study is to measure the effect of Diffusion Optics Technology (DOT) spectacle lenses on the choroidal thickness and choroidal vascularity index compared to control lenses.
- Conditions
- Myopia, Myopia Progression, Juvenile Myopia
- Being tested
- Diffusion Optics Technology (DOT) Pattern Spectacle Lens, Control Spectacle Lens
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion Optics Technology (DOT) Pattern Spectacle LensDevice
DOT Pattern Spectacle Lens
Control Spectacle LensDevice
Control Spectacles
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 - Diffusion Optics Technology (DOT) Pattern | Experimental | Not described Receives: Device: Diffusion Optics Technology (DOT) Pattern Spectacle Lens |
| Treatment 2 - Control Spectacles | Active comparator | Not described Receives: Device: Control Spectacle Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choroidal Thickness
Change from Baseline, 30 minutes and 60 minutes
Measured: 30 minutes and 60 minutes
Retinal and Choroidal Thickness
Change from Baseline, 30 minutes and 60 minutes
Measured: 30 minutes and 60 minutes
Secondary outcomes (1)
Software Method Comparison
Comparison of measurements using different software methods; manual, semiautomated and automated software
Measured: 30 minutes and 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start18 Jan 2023
- Primary completion30 Apr 2023
- 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 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SightGlass Vision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Waterloo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617794
- Sponsor's protocol ID
- CPRO-2207-001
- Acronym
- ASH-2
- Status last verified
- Apr 2026
- First submitted
- 1 Nov 2022
- Last updated
- 5 May 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 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Diffusion Optics Technology (DOT) Spectacle Lenses on Choroidal Thickness and Choroidal Vascularity Index in Emmetropes
- ClinicalTrials.gov ID
- NCT05617794
- Acronym / sponsor ID
- ASH-2 / CPRO-2207-001
- Conditions
- Myopia, Myopia Progression, Juvenile Myopia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- SightGlass Vision, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Waterloo
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Nov 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.
The objective of the study is to measure the effect of Diffusion Optics Technology (DOT) spectacle lenses on the choroidal thickness and choroidal vascularity index compared to control lenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 - Diffusion Optics Technology (DOT) Pattern | Experimental | Device: Diffusion Optics Technology (DOT) Pattern Spectacle Lens |
| Treatment 2 - Control Spectacles | Active comparator | Device: Control Spectacle Lens |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Are 8-14 years of age;
- Are able to read (or be read to), understand and sign the assent document;
- Are accompanied by a parent or legal guardian who is able to read, understand and sign the parental information and permission document;
- Are emmetropic by non-cycloplegic auto-refraction, which means both refractive meridians should be within +1.00D and -1.00D inclusively;
- Are willing and able to follow instructions.
Key exclusion criteria (8 listed)
- Are participating in any concurrent interventional clinical or research study;
- Have a history of myopia control treatment in the past year;
- Have amblyopia in either eye or known to have any other binocular vision disorder, such as accommodative insufficiency;
- Have any known active ocular disease and/or infection;
- Have a systemic condition that in the opinion of the investigator may affect a study outcome variable. Examples include diabetes mellitus, hyperthyroidism;
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 |
|---|---|---|
| Diffusion Optics Technology (DOT) Pattern Spectacle LensDOT Pattern Spectacle Lens | Device | Treatment 1 - Diffusion Optics Technology (DOT) Pattern |
| Control Spectacle LensControl Spectacles | Device | Treatment 2 - Control Spectacles |
Primary outcome
Choroidal Thickness
Time frame: 30 minutes and 60 minutes
Change from Baseline, 30 minutes and 60 minutes
Retinal and Choroidal Thickness
Time frame: 30 minutes and 60 minutes
Change from Baseline, 30 minutes and 60 minutes
1 secondary outcome
Software Method Comparison
Time frame: 30 minutes and 60 minutes
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 5 May 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diffusion Optics Technology (DOT) Pattern Spectacle Lens in people with Myopia and Myopia Progression, run by SightGlass Vision, Inc. at 1 site in Canada.
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 5 inclusion and 8 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 5 May 2026. 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 Canada. 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?
Choroidal Thickness (time frame: 30 minutes and 60 minutes). 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 5 May 2026.