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Active, not recruitingNCT07808047Updated Sep 8, 2026

Dynamic Pupil Variations and the Efficacy of Peripheral Defocus Spectacle Lenses in Slowing Myopia Progression

An observational study in Myopia Progressing, sponsored by Bambino Gesù Hospital and Research Institute. Active, not recruiting at 1 site in Italy. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Bambino Gesù Hospital and Research Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
14
Ages
6 Years to 18 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Myopia Progressing

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Keywords

  • myopia
  • dynamic pupillometry
  • spherical equivalent
  • axial lenght
03

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

primary care clinic

Inclusion criteria

progressive myopia

Exclusion criteria

Exclusion Criteria:

suspected genetic syndromes all systemic or eye diseases

04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
14 participants (actual)
Patient registry
No

Interventions

  • Deviceperifheral defocus spectacle lenses

    dynamic pupillometry measurement

  • Deviceperipheral defocus spectacle lens

    24 month follow up

05

What researchers measure

Primary outcomes

  1. pupil diameter change

    Time frame: From enrollment to 24 months follow up

  2. correlation between dynamic pupil and axial lenght change

    Time frame: from enrollment to 24 monts

06

Study locations

1 site
  • Luca Buzzonetti
    Roma, Italy
07

References and documents

Individual participant data

Plan to share: No — anonymous data will be presented

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07808047
Lead sponsor
Bambino Gesù Hospital and Research Institute
Responsible party
Luca Buzzonetti (Head Ophthalmology Unit, Bambino Gesù Hospital and Research Institute) — Principal investigator
First posted
Sep 8, 2026
Start date
Aug 1, 2024
Primary completion
Aug 1, 2026
Completion
Sep 1, 2026 (estimated)
Last update
Sep 8, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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