Pituitary TumorRetroADENNCT03363126
Visual Outcome After Transsphenoidal Surgery for Pituitary Macroadenoma
An observational study of Pituitary Tumor and Optic Chiasm Disorder, run by Fondation Ophtalmologique Adolphe de Rothschild.
Trial summary
Endoscopic endonasal transsphenoidal surgery is a procedure for the treatment of pituitary macroadenomas that cause visual impairment through optic chiasm compression. The aim of this retrospective study is to describe visual outcome after this procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pituitary Tumor, Optic Chiasm Disorder
- What is being tested?
- Endonasal transsphenoidal pituitary tumor removal
- Type of treatment
- Surgery or procedure
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2015to 20 Jun 2016
- 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: Patients treated in the Rothschild Foundation (Paris) between 2009 and 2013 by transsphenoidal endonasal surgery for pituitary tumor causing optic chiasm compression and visual disorders
Who may be able to join
- Pituitary tumor causing optic chiasm compression (documented on MRI or CT-scan)
- Visual impairment caused by chiasm compression
- Treatment by transsphenoidal endonasal surgery
- Treatment in the Rothschild Foundation (Paris) between 2009 and 2013
Who cannot join
- Ophtalmologic condition other than optic chiasm compression
About this study
Endoscopic endonasal transsphenoidal surgery is a procedure for the treatment of pituitary macroadenomas that cause visual impairment through optic chiasm compression. The aim of this retrospective study is to describe visual outcome after this procedure.
- Conditions
- Pituitary Tumor, Optic Chiasm Disorder
- Being tested
- Endonasal transsphenoidal pituitary tumor removal
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endonasal transsphenoidal pituitary tumor removalProcedure or surgery
Removal of pituitary tumor by transsphenoidal endonasal surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative gain in visual acuity
Difference between pre-operative and post-operative visual acuity, expressed in LogMAR
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start1 Sep 2015
- Primary completion10 Feb 2016
- Study completion20 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary TumorStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 88 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
- NCT03363126
- Sponsor's protocol ID
- CE_20160404_1_WEI
- Acronym
- RetroADEN
- Status last verified
- Nov 2017
- First submitted
- 30 Nov 2017
- Last updated
- 6 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Outcome After Transsphenoidal Surgery for Pituitary Macroadenoma
- ClinicalTrials.gov ID
- NCT03363126
- Acronym / sponsor ID
- RetroADEN / CE_20160404_1_WEI
- Conditions
- Pituitary Tumor, Optic Chiasm Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 10 Feb 2016 (actual)
- Study completion
- 20 Jun 2016 (actual)
- First posted
- 6 Dec 2017 (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.
Endoscopic endonasal transsphenoidal surgery is a procedure for the treatment of pituitary macroadenomas that cause visual impairment through optic chiasm compression. The aim of this retrospective study is to describe visual outcome after this procedure.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated in the Rothschild Foundation (Paris) between 2009 and 2013 by transsphenoidal endonasal surgery for pituitary tumor causing optic chiasm compression and visual disorders
Key inclusion criteria (4 listed)
- Pituitary tumor causing optic chiasm compression (documented on MRI or CT-scan)
- Visual impairment caused by chiasm compression
- Treatment by transsphenoidal endonasal surgery
- Treatment in the Rothschild Foundation (Paris) between 2009 and 2013
Key exclusion criteria (1 listed)
- Ophtalmologic condition other than optic chiasm compression
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 |
|---|---|---|
| Endonasal transsphenoidal pituitary tumor removalRemoval of pituitary tumor by transsphenoidal endonasal surgery | Procedure or surgery | – |
Primary outcome
Post-operative gain in visual acuity
Time frame: six months
Difference between pre-operative and post-operative visual acuity, expressed in LogMAR
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 Dec 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pituitary Tumor and Optic Chiasm Disorder, run by Fondation Ophtalmologique Adolphe de Rothschild.
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 4 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 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Post-operative gain in visual acuity (time frame: six 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 6 Dec 2017.