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

September 3, 2026 updated by: Luca Buzzonetti, Bambino Gesù Hospital and Research Institute

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy
        • Luca Buzzonetti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

primary care clinic

Description

Inclusion Criteria:

progressive myopia

Exclusion Criteria:

suspected genetic syndromes all systemic or eye diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pupil diameter change
Time Frame: From enrollment to 24 months follow up
From enrollment to 24 months follow up
correlation between dynamic pupil and axial lenght change
Time Frame: from enrollment to 24 monts
from enrollment to 24 monts

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bambino Gesù Hospital and Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Actual)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

September 3, 2026

First Submitted That Met QC Criteria

September 3, 2026

First Posted (Actual)

September 8, 2026

Study Record Updates

Last Update Posted (Actual)

September 8, 2026

Last Update Submitted That Met QC Criteria

September 3, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • myopia2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

anonymous data will be presented

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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