Juvenile MyopiaCYPRESSNCT04947735
CYPRESS Efficacy and Safety Study Extension
A study testing Novel spectacle lens design and Spectacle lenses in people with Juvenile Myopia and Myopia, run by SightGlass Vision, Inc. at 12 sites in 2 countries.
Trial summary
This is an open-label, controlled, multisite, two-arm parallel group clinical trial of 36-month duration to evaluate the continued safety and efficacy of SightGlass Vision Diffusion Optics Technology (DOT) Spectacles in reducing the progression of juvenile myopia. Read more about this study
- Who is it for?
- Ages 6 to 17 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?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 19 Jul 2021to 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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Previously a successfully completed participant in the CYPRESS study (NCT03623074) and having not exited this study for more than 30 days;
- 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 3 years 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
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
Dunes Eye Consultants
Dakota Dunes, South Dakota, 57049
Dr. Bridgitte Shen Lee (PI)
Houston, Texas, 77205
Omega Vision Center, PA
Longwood, Florida, 32779
Total Eye Care
Memphis, Tennessee, 38119
SUNY School of Optometry
New York, New York, 10036
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
Haik Humble
West Monroe, Louisiana, 71291
Golden Optometric Group
Whittier, California, 90606
Canada1 site
Centre for Ocular Research and Education
Waterloo, Ontario, N2L 3G1
About this study
Official title: Control of Myopia Using Peripheral Diffusion Lenses: Efficacy and Safety Study Extension
This is an open-label, controlled, multisite, two-arm parallel group clinical trial of 36-month duration to evaluate the continued safety and efficacy of SightGlass Vision Diffusion Optics Technology (DOT) Spectacles in reducing the progression of juvenile myopia.
- 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 single vision, impact resistant spectacle lenses may reduce the rate of progression of juvenile myopia
Spectacle lensesDevice
Single vision, impact resistant spectacle lenses
| Study group | Role | What they receive |
|---|---|---|
| CYPRESS Extension Test Arm | Experimental | Single vision, impact resistant spectacle lenses; CYPRESS Test Arm 1 and CYPRESS Test Arm 2 will move into CYPRESS Extension Test Arm Receives: Device: Novel spectacle lens design |
| CYPRESS Extension Control Arm | Placebo comparator | Single vision, impact resistant spectacle lenses; CYPRESS Control Arm remains in control lenses as the CYPRESS Extension Control Arm Receives: Device: Spectacle lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length
Test vs. control axial length change from baseline
Measured: 72 months
Spherical equivalent refraction (SER)
Test vs. control spherical equivalent refraction (SER) change from baseline
Measured: 72 months
Secondary outcomes (2)
Axial length
Change from baseline
Measured: 42 months
SER
Change from baseline
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start19 Jul 2021
- Primary completion31 Oct 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Juvenile 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
- 200 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
- NCT04947735
- Sponsor's protocol ID
- CPRO-1802-002
- Acronym
- CYPRESS
- Status last verified
- Apr 2026
- First submitted
- 18 Jun 2021
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Laughton D, Hill JS, McParland M, Tasso V, Woods J, Zhu X, Young G, Craven R, Hunt C, Neitz J, Neitz M, Chalberg TW, Jones D, Wolffsohn JS. Control of myopia using diffusion optics spectacle lenses: 4-year results of a multicentre randomised controlled, efficacy and safety study (CYPRESS). BMJ Open Ophthalmol. 2024 Oct 9;9(1):e001790. doi: 10.1136/bmjophth-2024-001790.
PubMed 39384223
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
- Control of Myopia Using Peripheral Diffusion Lenses: Efficacy and Safety Study Extension
- ClinicalTrials.gov ID
- NCT04947735
- Acronym / sponsor ID
- CYPRESS / CPRO-1802-002
- Conditions
- Juvenile Myopia, Myopia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- SightGlass Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Jul 2021 (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 an open-label, controlled, multisite, two-arm parallel group clinical trial of 36-month duration to evaluate the continued safety and efficacy of SightGlass Vision Diffusion Optics Technology (DOT) Spectacles in reducing the progression of juvenile myopia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CYPRESS Extension Test Arm | Experimental | Device: Novel spectacle lens designSingle vision, impact resistant spectacle lenses; CYPRESS Test Arm 1 and CYPRESS Test Arm 2 will move into CYPRESS Extension Test Arm |
| CYPRESS Extension Control Arm | Placebo comparator | Device: Spectacle lensesSingle vision, impact resistant spectacle lenses; CYPRESS Control Arm remains in control lenses as the CYPRESS Extension Control Arm |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Previously a successfully completed participant in the CYPRESS study (NCT03623074) and having not exited this study for more than 30 days;
- 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 3 years 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 |
|---|---|---|
| Novel spectacle lens designUse of single vision, impact resistant spectacle lenses may reduce the rate of progression of juvenile myopia | Device | CYPRESS Extension Test Arm |
| Spectacle lensesSingle vision, impact resistant spectacle lenses | Device | CYPRESS Extension Control Arm |
Primary outcome
Axial length
Time frame: 72 months
Test vs. control axial length change from baseline
Spherical equivalent refraction (SER)
Time frame: 72 months
Test vs. control spherical equivalent refraction (SER) change from baseline
2 secondary outcomes
Axial length
Time frame: 42 months
SER
Time frame: 60 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.
- Derived from this study: PubMed 39384223Laughton D, Hill JS, McParland M, Tasso V, Woods J, Zhu X, Young G, Craven R, Hunt C, Neitz J, Neitz M, Chalberg TW, Jones D, Wolffsohn JS. Control of myopia using diffusion optics spectacle lenses: 4-year results of a multicentre randomised controlled, efficacy and safety study (CYPRESS). BMJ Open Ophthalmol. 2024 Oct 9;9(1):e001790. doi: 10.1136/bmjophth-2024-001790.
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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.
12 sites in 2 countries: 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 12 sites in 2 countries.
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 12 sites in United States, 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. Some participants in this study may receive a placebo. 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: 72 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?
On the ClinicalTrials.gov record for NCT04947735, which also lists 1 linked publication.
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.