MyopiaBIRCHNCT05893979
Myopia Control Spectacle Lens Cessation Study
A study testing Spectacle Lenses in people with Myopia and Myopia Progression, run by SightGlass Vision, Inc. at 8 sites in United States.
Trial summary
To quantify myopic progression (cycloplegic spherical equivalent refraction - cSER) following the cessation of use of specific spectacle lenses. To quantify axial length progression following cessation of use of specific spectacle lenses. Read more about this study
- Who is it for?
- Ages 9 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Myopia Progression, Juvenile Myopia
- What is being tested?
- Spectacle Lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 8 sitesUnited States
- Study dates
- 23 Jun 2023to 31 Jul 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 9 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Previously a successfully completed participant in the CYPRESS Extension study;
- 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 up to 12 months without contact lens wear;
- 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
- Known allergy to proparacaine, tetracaine, or tropicamide.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Vision Optique
Houston, Texas, 77205
Omega Vision Center PA
Longwood, Florida, 32779
Total Eye Care
Memphis, Tennessee, 38119
Kannarr Eye Care
Pittsburg, Kansas, 66762
Advanced Eyecare PC
Raytown, Missouri, 64133
William J Bogus, OD, FAAO
Salt Lake City, Utah, 84106
Sacco Eye Group
Vestal, New York, 13850
Golden Optometric Group
Whittier, California, 90606
About this study
Official title: Myopia Control Spectacle Lens Use Cessation Study
To quantify myopic progression (cycloplegic spherical equivalent refraction - cSER) following the cessation of use of specific spectacle lenses.
To quantify axial length progression following cessation of use of specific spectacle lenses.
- Conditions
- Myopia, Myopia Progression, Juvenile Myopia
- Being tested
- 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.
Spectacle LensesDevice
Standard Spectacle Lenses
| Study group | Role | What they receive |
|---|---|---|
| Test Lens Group | Active comparator | Not described Receives: Device: Spectacle Lenses |
| Control Lens Group | Active comparator | Not described Receives: Device: Spectacle Lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cycloplegic Spherical Equivalent Refraction (cSER)
Change in cSER
Measured: 12 months
Secondary outcomes (2)
Cycloplegic Spherical Equivalent Refraction (cSER)
Change in cSER
Measured: 6 months
Axial Length (AL)
Change in AL
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 posted8 Jun 2023
- Study start23 Jun 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jul 2027 (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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 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
- NCT05893979
- Sponsor's protocol ID
- CPRO-2303-001
- Acronym
- BIRCH
- Status last verified
- Apr 2026
- First submitted
- 30 May 2023
- 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
- Myopia Control Spectacle Lens Use Cessation Study
- ClinicalTrials.gov ID
- NCT05893979
- Acronym / sponsor ID
- BIRCH / CPRO-2303-001
- Conditions
- Myopia, Myopia Progression, Juvenile Myopia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- SightGlass Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 8 Jun 2023 (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 quantify myopic progression (cycloplegic spherical equivalent refraction - cSER) following the cessation of use of specific spectacle lenses.
To quantify axial length progression following cessation of use of specific spectacle lenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Lens Group | Active comparator | Device: Spectacle Lenses |
| Control Lens Group | Active comparator | Device: Spectacle Lenses |
Who may qualify
- Ages
- 9 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Previously a successfully completed participant in the CYPRESS Extension study;
- 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 up to 12 months without contact lens wear;
- 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)
- Known allergy to proparacaine, tetracaine, or tropicamide.
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 |
|---|---|---|
| Spectacle LensesStandard Spectacle Lenses | Device | Control Lens Group, Test Lens Group |
Primary outcome
Cycloplegic Spherical Equivalent Refraction (cSER)
Time frame: 12 months
Change in cSER
2 secondary outcomes
Cycloplegic Spherical Equivalent Refraction (cSER)
Time frame: 6 months
Axial Length (AL)
Time frame: 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 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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spectacle Lenses in people with Myopia and Myopia Progression, run by SightGlass Vision, Inc. at 8 sites in United States.
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: 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 8 sites in United States. 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?
Cycloplegic Spherical Equivalent Refraction (cSER) (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 5 May 2026.