Myopia ProgressingNCT07808047
Dynamic Pupil Variations and the Efficacy of Peripheral Defocus Spectacle Lenses in Slowing Myopia Progression
An observational study of Myopia Progressing, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
Trial summary
to evaluate the correlation between dynamic pupil variations and the efficacy of spectacle lenses in myopia progression control Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Myopia Progressing
- What is being tested?
- perifheral defocus spectacle lenses and peripheral defocus spectacle lens
- Type of treatment
- Medical device
- How many people
- 14 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2024to 1 Sep 2026
- Phase
- Observational
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: primary care clinic
Who may be able to join
- progressive myopia
Who cannot join
- suspected genetic syndromes all systemic or eye diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Dynamic Pupil Variations and the Efficacy of Peripheral Defocus Spectacle Lenses in Slowing Myopia Progression in Pediatric Patients
to evaluate the correlation between dynamic pupil variations and the efficacy of spectacle lenses in myopia progression control
Read the detailed description
to evaluate if the dynamic nature of the pupil throughout the day could directly modulates the efficacy of spectacle lenses in myopia progression control in European pediatric patients.
- Conditions
- Myopia Progressing
- Being tested
- perifheral defocus spectacle lenses, peripheral defocus spectacle lens
- Keywords
- myopia, dynamic pupillometry, spherical equivalent, axial lenght
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perifheral defocus spectacle lensesDevice
dynamic pupillometry measurement
peripheral defocus spectacle lensDevice
24 month follow up
What is being measured
The primary outcome is the main question the study is designed to answer.
pupil diameter change
Measured: From enrollment to 24 months follow up
correlation between dynamic pupil and axial lenght change
Measured: from enrollment to 24 monts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Aug 2024
- Primary completion1 Aug 2026
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia ProgressingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bambino Gesù Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Buzzonetti, Bambino Gesù Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808047
- Sponsor's protocol ID
- myopia2
- Status last verified
- Aug 2026
- First submitted
- 3 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: anonymous data will be presented
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Dynamic Pupil Variations and the Efficacy of Peripheral Defocus Spectacle Lenses in Slowing Myopia Progression in Pediatric Patients
- ClinicalTrials.gov ID
- NCT07808047
- Acronym / sponsor ID
- myopia2
- Conditions
- Myopia Progressing
- Keywords
- myopia, dynamic pupillometry, spherical equivalent, axial lenght
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Bambino Gesù Hospital and Research InstituteUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 8 Sep 2026 (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 evaluate the correlation between dynamic pupil variations and the efficacy of spectacle lenses in myopia progression control
Detailed description
to evaluate if the dynamic nature of the pupil throughout the day could directly modulates the efficacy of spectacle lenses in myopia progression control in European pediatric patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- primary care clinic
Key inclusion criteria (1 listed)
- progressive myopia
Key exclusion criteria (1 listed)
- suspected genetic syndromes all systemic or eye diseases
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 |
|---|---|---|
| perifheral defocus spectacle lensesdynamic pupillometry measurement | Device | – |
| peripheral defocus spectacle lens24 month follow up | Device | – |
Primary outcome
pupil diameter change
Time frame: From enrollment to 24 months follow up
correlation between dynamic pupil and axial lenght change
Time frame: from enrollment to 24 monts
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 8 Sep 2026.
- Individual participant dataSharing planned: No. anonymous data will be presented
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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?
An observational study of Myopia Progressing, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
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 1 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 8 Sep 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 Italy. 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?
pupil diameter change (time frame: From enrollment to 24 months follow up). 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 8 Sep 2026.