Glaucoma Open-Angle PrimaryNCT05455567
OCTA Study of Choroidal Vasculature in Open Angle Glaucoma Patients
An observational study of Glaucoma Open-Angle Primary, run by Federico II University at 1 site in Italy.
Trial summary
The aim of the present study was to examine and measure SFCT and CCVD using respectively EDI-OCT and OCTA in preperimetric and advanced glaucomatous eyes, in order to shed light on the vascular pathogenesis of glaucoma disease. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma Open-Angle Primary
- What is being tested?
- OCTA
- How many people
- 57 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2022to 15 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The participans were older than 40 years with diagnosis of open angle glaucoma. They did not present any other ophthalmological disease, diabetes, heart diseases and hypertension.
Who may be able to join
- diagnosis of glaucoma
- absence of diabetes, heart diseases, hypertension
- absence of drug intake
- absence of vitreoretinal, vascular retinal diseases
- absence of previous ocular surgery and congenital eye diseases.
- absence of errors of refraction
- absence of lens opacities
- absence of low-quality OCT and OCTA images
Who cannot join
- age younger than 40 years
- presence of diabetes, heart diseases, hypertension
- vitreoretinal and vascular retinal diseases
- previous ocular surgery and congenital eye diseases
- errors of refraction
- lens opacities
- low-quality OCT and OCTA images
Trial locations and contacts
1 site in 1 country.
About this study
Official title: OCTA as a New Biomarker in the Pathogenesis of Primary Open Angle Glaucoma
The aim of the present study was to examine and measure SFCT and CCVD using respectively EDI-OCT and OCTA in preperimetric and advanced glaucomatous eyes, in order to shed light on the vascular pathogenesis of glaucoma disease.
- Conditions
- Glaucoma Open-Angle Primary
- Being tested
- OCTA
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCTADiagnostic test
Choriocapillary vessel density calculated with OCTA
| Study group | Role | What they receive |
|---|---|---|
| patients with pre perimetric open angle glaucoma | Not described Receives: Diagnostic Test: OCTA | |
| patients with perimetric open angle glaucoma | Not described Receives: Diagnostic Test: OCTA | |
| healthy patients | Not described Receives: Diagnostic Test: OCTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The measurements of choroidal thickness and choriocapillary vessel density in patients with open angle glaucoma.
correlation of measurement of choroidal thickness and choriocapillary vessel density in three different patients groups
Measured: up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start1 Feb 2022
- Primary completion30 Apr 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma Open-Angle PrimaryStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilda Cennamo, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455567
- Sponsor's protocol ID
- 0102/22
- Status last verified
- Jul 2022
- First submitted
- 7 Jul 2022
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCTA as a New Biomarker in the Pathogenesis of Primary Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT05455567
- Acronym / sponsor ID
- 0102/22
- Conditions
- Glaucoma Open-Angle Primary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 13 Jul 2022 (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.
The aim of the present study was to examine and measure SFCT and CCVD using respectively EDI-OCT and OCTA in preperimetric and advanced glaucomatous eyes, in order to shed light on the vascular pathogenesis of glaucoma disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients with pre perimetric open angle glaucoma | – | Diagnostic Test: OCTA |
| patients with perimetric open angle glaucoma | – | Diagnostic Test: OCTA |
| healthy patients | – | Diagnostic Test: OCTA |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The participans were older than 40 years with diagnosis of open angle glaucoma. They did not present any other ophthalmological disease, diabetes, heart diseases and hypertension.
Key inclusion criteria (8 listed)
- diagnosis of glaucoma
- absence of diabetes, heart diseases, hypertension
- absence of drug intake
- absence of vitreoretinal, vascular retinal diseases
- absence of previous ocular surgery and congenital eye diseases.
Key exclusion criteria (7 listed)
- age younger than 40 years
- presence of diabetes, heart diseases, hypertension
- vitreoretinal and vascular retinal diseases
- previous ocular surgery and congenital eye diseases
- errors of refraction
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 |
|---|---|---|
| OCTAChoriocapillary vessel density calculated with OCTA | Diagnostic test | healthy patients, patients with perimetric open angle glaucoma, patients with pre perimetric open angle glaucoma |
Primary outcome
The measurements of choroidal thickness and choriocapillary vessel density in patients with open angle glaucoma.
Time frame: up to 5 months
correlation of measurement of choroidal thickness and choriocapillary vessel density in three different patients groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Individual participant dataSharing planned: Yes
Related trials for Glaucoma Open-Angle Primary
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Glaucoma Open-Angle Primary, run by Federico II University 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 8 inclusion and 7 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: finished, as of the sponsor's last update on 25 Jul 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The measurements of choroidal thickness and choriocapillary vessel density in patients with open angle glaucoma. (time frame: up to 5 months). 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 25 Jul 2022.