Pathologic MyopiaFWUPMIOPIA_ ENCT06322433
Follow up of High Myopic Eyes
An observational study of Pathologic Myopia, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pathologic Myopia
- What is being tested?
- no drugs used for this study
- How many people
- 138 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2023to 31 Dec 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: cohort of patients presenting at our Institution with eye myopia
Who may be able to join
- high myopia
Who cannot join
- acute ischemic optic neuropathy
- macular and peripapillary atrophy
- other forms of maculopathy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Auxologico Italiano IRCCS
Milan, 20145
Paolo Milani, MD
About this study
Official title: Long Term Follow-up of Eyes With High Myopia
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.
- Conditions
- Pathologic Myopia
- Being tested
- no drugs used for this study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no drugs used for this studyDiagnostic test
tomographic, angiographic and clinical follow up
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with neovascularization at follow-up visit
Evaluation of choroidal neovascularization
Measured: at 5 years of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start1 Nov 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathologic MyopiaStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322433
- Sponsor's protocol ID
- 37C301
- Acronym
- FWUPMIOPIA_ E
- Status last verified
- Apr 2025
- First submitted
- 14 Mar 2024
- Last updated
- 1 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow-up of Eyes With High Myopia
- ClinicalTrials.gov ID
- NCT06322433
- Acronym / sponsor ID
- FWUPMIOPIA_ E / 37C301
- Conditions
- Pathologic Myopia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Mar 2024 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cohort of patients presenting at our Institution with eye myopia
Key inclusion criteria (1 listed)
- high myopia
Key exclusion criteria (3 listed)
- acute ischemic optic neuropathy
- macular and peripapillary atrophy
- other forms of maculopathy
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 |
|---|---|---|
| no drugs used for this studytomographic, angiographic and clinical follow up | Diagnostic test | – |
Primary outcome
Proportion of subjects with neovascularization at follow-up visit
Time frame: at 5 years of follow up
Evaluation of choroidal neovascularization
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 1 May 2025.
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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.
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 Pathologic Myopia, run by Istituto Auxologico Italiano 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 3 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: looking for participants now, as of the sponsor's last update on 1 May 2025. 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?
Contact Paolo Milani, MD (+390261911, dottpaolomilani@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with neovascularization at follow-up visit (time frame: at 5 years of follow up). 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 1 May 2025.