Tuberculum Sellae MeningiomaPRONOPTICNCT03567486
Predictive Factors of Visual Recovery After Paraoptic Tumors Removal
An observational study of Tuberculum Sellae Meningioma, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Paraoptic tumors - including mostly sellar meningiomas, pituitary gland adenomas and craniopharyngiomas - classically affect the visual function. Some preoperative factors, determined on retrospective studies, are known to constitute bad prognostic factors, such as duration of symptoms and retinal nerve fiber layer… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculum Sellae Meningioma
- How many people
- 99 participants
- Where
- 1 siteFrance
- Study dates
- 18 Dec 2017to 11 Jan 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: tuberculum sellae meningioma
Who may be able to join
- tuberculum sellae meningioma surgical indication
Who cannot join
- surgical contra indication MRI contra indication optical disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Paraoptic Tumors : Study of the Radiological, Ophthalmological and Intraoperative Predictive Factors of Visual Recovery After Neurosurgical Removal
Paraoptic tumors - including mostly sellar meningiomas, pituitary gland adenomas and craniopharyngiomas - classically affect the visual function. Some preoperative factors, determined on retrospective studies, are known to constitute bad prognostic factors, such as duration of symptoms and retinal nerve fiber layer thinning on OCT. We propose to perform a single center prospective study in which detailed preoperative ophthalmological and radiological criteria will be collected before surgery. Intraoperative information will be noted as well. All these data will be statistically examined regarding the postoperative visual recovery at 3, 6 and 12 months
- Conditions
- Tuberculum Sellae Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tuberculum sellae meningiomas | Adult patient suffering from tuberculum sellae meningiomas with surgical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
variation of Visual field
Measured: between before surgery and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start18 Dec 2017
- Primary completion31 Dec 2022
- Study completion11 Jan 2024
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 Tuberculum Sellae MeningiomaStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567486
- Sponsor's protocol ID
- DCT_2017_18
- Acronym
- PRONOPTIC
- Status last verified
- Jun 2025
- First submitted
- 13 Jun 2018
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lozouet M, Saadoun A, Menard A, Aldea S, Jaoude SA, Heran F, Yavchitz A, Philibert M, Chauvet D. Visual outcomes after pituitary adenoma surgery: Associated factors and longitudinal progression in a prospective single-centre study. Clin Neurol Neurosurg. 2026 Aug;267:109409. doi: 10.1016/j.clineuro.2026.109409. Epub 2026 Mar 28.
PubMed 41921421
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paraoptic Tumors : Study of the Radiological, Ophthalmological and Intraoperative Predictive Factors of Visual Recovery After Neurosurgical Removal
- ClinicalTrials.gov ID
- NCT03567486
- Acronym / sponsor ID
- PRONOPTIC / DCT_2017_18
- Conditions
- Tuberculum Sellae Meningioma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 11 Jan 2024 (actual)
- First posted
- 25 Jun 2018 (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.
Paraoptic tumors - including mostly sellar meningiomas, pituitary gland adenomas and craniopharyngiomas - classically affect the visual function. Some preoperative factors, determined on retrospective studies, are known to constitute bad prognostic factors, such as duration of symptoms and retinal nerve fiber layer thinning on OCT. We propose to perform a single center prospective study in which detailed preoperative ophthalmological and radiological criteria will be collected before surgery. Intraoperative information will be noted as well. All these data will be statistically examined regarding the postoperative visual recovery at 3, 6 and 12 months
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tuberculum sellae meningiomas | – | –Adult patient suffering from tuberculum sellae meningiomas with surgical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- tuberculum sellae meningioma
Key inclusion criteria (1 listed)
- tuberculum sellae meningioma surgical indication
Key exclusion criteria (1 listed)
- surgical contra indication MRI contra indication optical disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
variation of Visual field
Time frame: between before surgery and 6 months postoperatively
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 11 Jun 2025.
- Derived from this study: PubMed 41921421Lozouet M, Saadoun A, Menard A, Aldea S, Jaoude SA, Heran F, Yavchitz A, Philibert M, Chauvet D. Visual outcomes after pituitary adenoma surgery: Associated factors and longitudinal progression in a prospective single-centre study. Clin Neurol Neurosurg. 2026 Aug;267:109409. doi: 10.1016/j.clineuro.2026.109409. Epub 2026 Mar 28.
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 Tuberculum Sellae Meningioma, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site 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 1 inclusion and 1 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 11 Jun 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 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?
variation of Visual field (time frame: between before surgery and 6 months postoperatively). 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 NCT03567486, 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 11 Jun 2025.