NCT06322433

Brief Summary

In this non-interventional retrospective and prospective observational study, the long-term evolution of clinical and iconographic characteristics of patients with pathological myopia will be considered Changes of some specific clinical, tomographic and angiographic variables evaluated on the baseline and after a minimum of 5 years follow-up will be studied.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 21, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

2.2 years

First QC Date

March 14, 2024

Last Update Submit

April 30, 2025

Conditions

Pathologic Myopia

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects with neovascularization at follow-up visit

    Evaluation of choroidal neovascularization

    at 5 years of follow up

Interventions

no drugs used for this studyDIAGNOSTIC_TEST

tomographic, angiographic and clinical follow up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

cohort of patients presenting at our Institution with eye myopia

You may qualify if:

  • \- high myopia

You may not qualify if:

  • acute ischemic optic neuropathy
  • macular and peripapillary atrophy
  • other forms of maculopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano IRCCS

Milan, 20145, Italy

RECRUITING

Central Study Contacts

Paolo Milani, MD

CONTACT

+390261911dottpaolomilani@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2024

First Posted

March 21, 2024

Study Start

November 1, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

May 1, 2025

Record last verified: 2025-04

Locations

IT(1)