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
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