Pituitary AdenomaNCT04425954
Evaluation of Early Retinal Vascular Modifications After Endoscopic Endonasal Pituitary Surgery
An observational study of Pituitary Adenoma, run by Federico II University at 1 site in Italy.
Trial summary
This study evaluates the retinal vascular features using optical coherence tomography angiography in patients that received endoscopic endonasal approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pituitary Adenoma
- What is being tested?
- Endoscopic Endonasal Pituitary Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 14 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2019to 31 Mar 2019
- 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 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The participans were older than 45 years with pituitary adenoma. They did not present other ophthalmological and neurological diseases.
Who may be able to join
- age older than 45 years
- diagnosis of pituitary adenoma
- treatment-naïve with Endoscopic Endonasal Pituitary Surgery
- absence of other neurological diseases
- absence of vitreoretinal and vascular retinal diseases
Who cannot join
- age younger than 45 years
- No diagnosis of pituitary adenoma
- previous treatments with Endoscopic Endonasal Pituitary Surgery
- presence of neurological diseases
- presence of vitreoretinal and vascular retinal diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Retinal Vascular Modifications After Endoscopic Endonasal Pituitary Surgery: The Role of OCT- Angiography
This study evaluates the retinal vascular features using optical coherence tomography angiography in patients that received endoscopic endonasal approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.
Read the detailed description
To investigate the potential role of optical coherence tomography angiography in predicting the postoperative recovery of retinal vascular network of the optic disc in patients before and at 3 months after Endoscopic Endonasal Approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.
The optical coherence tomography angiography represents a novel and non-invasive diagnostic technique that allows a detailed analysis of retinal vascular features.
- Conditions
- Pituitary Adenoma
- Being tested
- Endoscopic Endonasal Pituitary Surgery
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Endonasal Pituitary SurgeryProcedure or surgery
Surgical treatment consisted of an endoscopic endonasal approach using a rigid 0-degree endoscope, 18 cm in length and 4 mm in diameter.
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of vessel density of the optic disc in patients underwent Endoscopic Endonasal Pituitary Surgery for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.
To evaluate the role of optical coherence tomography angiography in predicting the recovery of the vessel density of the optic disc after surgery, using optical coherence tomography angiography (OCTA). The parameter analyzed by OCTA was the vessel density of the optic disc (percent)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Jan 2019
- Primary completion1 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary AdenomaStudies 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
- Retrospective
- Enrolment
- 14 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
- Investigators
- Gilda Cennamo, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425954
- Sponsor's protocol ID
- PT 2006/20
- Status last verified
- Jun 2020
- First submitted
- 8 Jun 2020
- Last updated
- 16 Jun 2020
- 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 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Retinal Vascular Modifications After Endoscopic Endonasal Pituitary Surgery: The Role of OCT- Angiography
- ClinicalTrials.gov ID
- NCT04425954
- Acronym / sponsor ID
- PT 2006/20
- Conditions
- Pituitary Adenoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 11 Jun 2020 (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.
This study evaluates the retinal vascular features using optical coherence tomography angiography in patients that received endoscopic endonasal approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.
Detailed description
To investigate the potential role of optical coherence tomography angiography in predicting the postoperative recovery of retinal vascular network of the optic disc in patients before and at 3 months after Endoscopic Endonasal Approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.
The optical coherence tomography angiography represents a novel and non-invasive diagnostic technique that allows a detailed analysis of retinal vascular features.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The participans were older than 45 years with pituitary adenoma. They did not present other ophthalmological and neurological diseases.
Key inclusion criteria (5 listed)
- age older than 45 years
- diagnosis of pituitary adenoma
- treatment-naïve with Endoscopic Endonasal Pituitary Surgery
- absence of other neurological diseases
- absence of vitreoretinal and vascular retinal diseases
Key exclusion criteria (5 listed)
- age younger than 45 years
- No diagnosis of pituitary adenoma
- previous treatments with Endoscopic Endonasal Pituitary Surgery
- presence of neurological diseases
- presence of vitreoretinal and vascular retinal diseases
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 |
|---|---|---|
| Endoscopic Endonasal Pituitary SurgerySurgical treatment consisted of an endoscopic endonasal approach using a rigid 0-degree endoscope, 18 cm in length and 4 mm in diameter. | Procedure or surgery | – |
Primary outcome
Study of vessel density of the optic disc in patients underwent Endoscopic Endonasal Pituitary Surgery for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.
Time frame: 48 hours
To evaluate the role of optical coherence tomography angiography in predicting the recovery of the vessel density of the optic disc after surgery, using optical coherence tomography angiography (OCTA). The parameter analyzed by OCTA was the vessel density of the optic disc (percent)
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 16 Jun 2020.
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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. This study is not recruiting at the moment.
Gilda Cennamo principal investigator
Federico II University
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 Pituitary Adenoma, 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 5 inclusion and 5 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 16 Jun 2020. 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?
Study of vessel density of the optic disc in patients underwent Endoscopic Endonasal Pituitary Surgery for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve. (time frame: 48 hours). 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 16 Jun 2020.