Pituitary AdenomaNCT04840771
Predictive OCTA Biomarkers 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 structural parameters, by spectral domain optical coherence tomography (OCT), retinal vessel density, using OCT angiography, and visual acuity 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 40 to 65 years
- Conditions the study is for
- Pituitary Adenoma
- What is being tested?
- Endoscopic Endonasal Pituitary Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 8 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2020to 31 Jul 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The participans were older than 4 years with pituitary adenoma. They did not present other ophthalmological and neurological diseases.
Who may be able to join
- age older than 40 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 40 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: Optical Cohrence Tomography Angiography as a New Predictive Biomarker in Anatomical and Functional Recovery After Endoscopic Endonasal Pituitary Surgery: a Prospective Study
This study evaluates the structural parameters, by spectral domain optical coherence tomography (OCT), retinal vessel density, using OCT angiography, and visual acuity in patients that received endoscopic endonasal approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.
Read the detailed description
The primary outcome was to detect the changes in visual acuity, retinal structural and vascular features at 48 hours and 1 year after Endoscopic Endonasal Approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.
The secondary outcome was to identify potential biomarker that could predict the functional recovery at 1 year follow up.
- 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.
Comparison between retinal structures before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery
8 patients with pituitary adenoma compressing optic chiasm. Changes in thickness of ganglion cell complex (microns) and in thickness of retinal nerve fiber layer (microns) before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery
Measured: 48 hours and 1 year follow up
Comparison between retinal microvasculature before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery
8 patients with pituitary adenoma compressing optic chiasm. Changes in retinal vessel density (percent) in macular and papillary regions before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery
Measured: 48 hours and 1 year follow up
Secondary outcomes (2)
Correlation between retinal structures and visual acuity after Endoscopic Endonasal Pituitary Surgery
8 patients with pituitary adenoma compressing optic chiasm underwent Endoscopic Endonasal Pituitary Surgery.
Correlation between ganglion cell complex, retinal nerve fiber layer thicknesses (microns) at baseline and visual acuity recovery (logMAR) 1 year after surgery.
Measured: 1 year follow up
Correlation between retinal microvasculature and visual acuity after Endoscopic Endonasal Pituitary Surgery
8 patients with pituitary adenoma compressing optic chiasm underwent Endoscopic Endonasal Pituitary Surgery.
Correlation between retinal vessel density (percent) at baseline and visual acuity recovery (logMAR) 1 year after surgery.
Measured: 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start1 Jun 2020
- Primary completion30 Jul 2020
- Study completion31 Jul 2020
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.
- 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
- 8 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
- NCT04840771
- Sponsor's protocol ID
- 04/21
- Status last verified
- May 2021
- First submitted
- 4 Apr 2021
- Last updated
- 6 May 2021
- 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 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Cohrence Tomography Angiography as a New Predictive Biomarker in Anatomical and Functional Recovery After Endoscopic Endonasal Pituitary Surgery: a Prospective Study
- ClinicalTrials.gov ID
- NCT04840771
- Acronym / sponsor ID
- 04/21
- Conditions
- Pituitary Adenoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 12 Apr 2021 (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 structural parameters, by spectral domain optical coherence tomography (OCT), retinal vessel density, using OCT angiography, and visual acuity in patients that received endoscopic endonasal approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.
Detailed description
The primary outcome was to detect the changes in visual acuity, retinal structural and vascular features at 48 hours and 1 year after Endoscopic Endonasal Approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.
The secondary outcome was to identify potential biomarker that could predict the functional recovery at 1 year follow up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participans were older than 4 years with pituitary adenoma. They did not present other ophthalmological and neurological diseases.
Key inclusion criteria (5 listed)
- age older than 40 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 40 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
Comparison between retinal structures before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery
Time frame: 48 hours and 1 year follow up
8 patients with pituitary adenoma compressing optic chiasm. Changes in thickness of ganglion cell complex (microns) and in thickness of retinal nerve fiber layer (microns) before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery
Comparison between retinal microvasculature before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery
Time frame: 48 hours and 1 year follow up
8 patients with pituitary adenoma compressing optic chiasm. Changes in retinal vessel density (percent) in macular and papillary regions before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery
2 secondary outcomes
Correlation between retinal structures and visual acuity after Endoscopic Endonasal Pituitary Surgery
Time frame: 1 year follow up
Correlation between retinal microvasculature and visual acuity after Endoscopic Endonasal Pituitary Surgery
Time frame: 1 year follow up
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 6 May 2021.
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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 6 May 2021. 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?
Comparison between retinal structures before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery (time frame: 48 hours and 1 year follow up). The study lists 2 primary outcomes in all. 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 6 May 2021.