Pituitary AdenomaFIRSTNCT04074642
OCT-angiography as a Pronostic Marker for Visual Impairment in Patients Undergoing Neurosurgery for Compressive Macroadenoma : a Prospective Study.
A study testing Neurosurgery in people with Pituitary Adenoma, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
Trial summary
The aim of the study is to assess accurancy of OCT angiography as a pronostic marker for patients undergoing neurosurgery for compressiver macroadenoma as compared with visual acuity, visual field and OCT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pituitary Adenoma
- What is being tested?
- Neurosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesFrance
- Study dates
- 14 Nov 2019to 22 Feb 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pituitary compressive adenoma (for experimental group)
- pituitary non compressive adenoma
Who cannot join
- retinian disease
- amblyopia
- parkinson disease
- pregnant woman
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de NICE
Nice, 06000
Hôpital Pasteur 2 - Service d'Ophtalmologie
Nice, 06001
About this study
The aim of the study is to assess accurancy of OCT angiography as a pronostic marker for patients undergoing neurosurgery for compressiver macroadenoma as compared with visual acuity, visual field and OCT.
- Conditions
- Pituitary Adenoma
- Being tested
- Neurosurgery
- Keywords
- macroadenoma
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurosurgeryProcedure or surgery
adenoma removal
| Study group | Role | What they receive |
|---|---|---|
| Non compressive adenoma | No intervention | Optical Coherence Tomography Angiography without surgery |
| Compressive adenoma | Experimental | Optical Coherence Tomography Angiography before and after neurosurgery Receives: Procedure: Neurosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of middle deviation
visual field evolution assessed by Middle deviation
Measured: before surgery (= inclusion), 4 months after surgery and 10 months after surgery
Change of visual function index
visual field evolution assessed by visual function index
Measured: before surgery (= inclusion), 4 months after surgery and 10 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start14 Nov 2019
- Primary completion22 Feb 2023
- Study completion22 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pituitary AdenomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ARNAUD MARTEL, Principal investigator, ophtalmology department, Nice University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074642
- Sponsor's protocol ID
- 19-AOI-06
- Acronym
- FIRST
- Status last verified
- Mar 2026
- First submitted
- 20 Aug 2019
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Toumi E, Almairac F, Mondot L, Themelin A, Decoux-Poullot AG, Paquis P, Chevalier N, Baillif S, Nahon-Esteve S, Martel A. Benefit of Optical Coherence Tomography-Angiography in Patients Undergoing Transsphenoidal Pituitary Adenoma Surgery: A Prospective Controlled Study. Diagnostics (Basel). 2024 Aug 12;14(16):1747. doi: 10.3390/diagnostics14161747.
PubMed 39202235
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCT-angiography as a Pronostic Marker for Visual Impairment in Patients Undergoing Neurosurgery for Compressive Macroadenoma : a Prospective Study.
- ClinicalTrials.gov ID
- NCT04074642
- Acronym / sponsor ID
- FIRST / 19-AOI-06
- Conditions
- Pituitary Adenoma
- Keywords
- macroadenoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 14 Nov 2019 (actual)
- Primary completion
- 22 Feb 2023 (actual)
- Study completion
- 22 Feb 2023 (actual)
- First posted
- 30 Aug 2019 (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 study is to assess accurancy of OCT angiography as a pronostic marker for patients undergoing neurosurgery for compressiver macroadenoma as compared with visual acuity, visual field and OCT.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non compressive adenoma | No intervention | –Optical Coherence Tomography Angiography without surgery |
| Compressive adenoma | Experimental | Procedure: NeurosurgeryOptical Coherence Tomography Angiography before and after neurosurgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- pituitary compressive adenoma (for experimental group)
- pituitary non compressive adenoma
Key exclusion criteria (4 listed)
- retinian disease
- amblyopia
- parkinson disease
- pregnant woman
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 |
|---|---|---|
| Neurosurgeryadenoma removal | Procedure or surgery | Compressive adenoma |
Primary outcome
change of middle deviation
Time frame: before surgery (= inclusion), 4 months after surgery and 10 months after surgery
visual field evolution assessed by Middle deviation
Change of visual function index
Time frame: before surgery (= inclusion), 4 months after surgery and 10 months after surgery
visual field evolution assessed by visual function index
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 24 Mar 2026.
- Results publication: PubMed 39202235Toumi E, Almairac F, Mondot L, Themelin A, Decoux-Poullot AG, Paquis P, Chevalier N, Baillif S, Nahon-Esteve S, Martel A. Benefit of Optical Coherence Tomography-Angiography in Patients Undergoing Transsphenoidal Pituitary Adenoma Surgery: A Prospective Controlled Study. Diagnostics (Basel). 2024 Aug 12;14(16):1747. doi: 10.3390/diagnostics14161747.
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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.
ARNAUD MARTEL principal investigator
ophtalmology department, Nice University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurosurgery in people with Pituitary Adenoma, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
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 2 inclusion and 4 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 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
change of middle deviation (time frame: before surgery (= inclusion), 4 months after surgery and 10 months after surgery). 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?
On the ClinicalTrials.gov record for NCT04074642, which also lists 1 linked publication.
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 24 Mar 2026.