Pituitary MassOCTNCT03087682
Pituitary Gland Enlargement Was First Diagnosed by Optical Coherence Tomography (OCT)
An observational study of Pituitary Mass and Diagnoses Disease, run by Dr. S.S. Michel Clinic at 1 site in Canada.
Trial summary
OCT is now an established way to measure the thickness of the Retinal Nerve Fiber Layer (RNFL) in the retina of the eye. The thickness of the RNFL is always a reflection of the number of the RNFs in any particular area of the retina. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Pituitary Mass, Diagnoses Disease
- What is being tested?
- Optical Coherence Tomography (OCT)
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2013to Aug 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any patient who presents with frequent or persistent headache of unknown reason.
Who may be able to join
- healthy patients with frequent or persistent headache of unknown reasons.
Who cannot join
- patients who were previously diagnosed with or treated from pituitary enlargement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pituitary Gland Enlargement Was First Diagnosed by OCT Before There Were Any Changes at All in the Computerized and Automated Eighty Degrees Peripheral Visual Fields
OCT is now an established way to measure the thickness of the Retinal Nerve Fiber Layer (RNFL) in the retina of the eye. The thickness of the RNFL is always a reflection of the number of the RNFs in any particular area of the retina. Each single RNF runs a long course starting from the cell body which is the retinal ganglion cell in the retina and ends in the thalamus of the brain where it relays visual information to other nerve cell in the thalamus. Along this long course RNFs are in close anatomical relationship with the pituitary gland crossing just above this gland about midway along their course. Hence enlargement of this gland can interfere with the RNFs.
Read the detailed description
The inferior chiasmal syndrome is known to be caused by pituitary gland enlightenment because the pituitary gland lies just below the optic chiasma. The visual RNFs are organized in a very specific way along their long course from the retina to the Lateral Geniculate Body (LGB) in the thalamus. Pituitary enlargement would compromise particular RNFs. It is well known and established that pituitary enlargement, if not properly treated in time, would possibly cause bitemporal hemianopia due to interference with the crossing RNFs of the nasal half of each retina. In this study pituitary enlargement was suspected by OCT findings while the patient still had perfect peripheral visual field in each eye.
- Conditions
- Pituitary Mass, Diagnoses Disease
- Being tested
- Optical Coherence Tomography (OCT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence Tomography (OCT)Diagnostic test
OCT is used to measure thickness (numbers) of retinal nerve fibres in different areas of the retina
What is being measured
The primary outcome is the main question the study is designed to answer.
Thinning of the retinal nerve fibers (RNF) that are nearest to the pituitary gland, measured in micro-millimeters in OCT, were the first indication of possible enlargement of this gland.
Pituitary gland enlargement if not treated in time can have devastating effects on vision. Early diagnosis and treatment of this problem can not be over stressed. This study describes thinning of particular RNF in each eye that led to the suspicion of pituitary enlargement and was an early sign of the inferior chiasmal syndrome. Imaging studies were used to validate the suspected result.
Measured: through study completion, an average of one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start1 Feb 2013
- Primary completion15 Mar 2014
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary MassStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. S.S. Michel Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Shawkat Michel, Dr. S.S. Michel Clinic
- Investigators
- Shawkat S Michel, FRCS Ed, Principal investigator, Dr. S.S. Michel Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087682
- Sponsor's protocol ID
- Pituitary gland enlargement
- Acronym
- OCT
- Status last verified
- Mar 2017
- First submitted
- 12 Mar 2017
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- 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 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pituitary Gland Enlargement Was First Diagnosed by OCT Before There Were Any Changes at All in the Computerized and Automated Eighty Degrees Peripheral Visual Fields
- ClinicalTrials.gov ID
- NCT03087682
- Acronym / sponsor ID
- OCT / Pituitary gland enlargement
- Conditions
- Pituitary Mass, Diagnoses Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Dr. S.S. Michel ClinicUniversity, hospital or other
- Study start
- 1 Feb 2013 (actual)
- Primary completion
- 15 Mar 2014 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 22 Mar 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.
OCT is now an established way to measure the thickness of the Retinal Nerve Fiber Layer (RNFL) in the retina of the eye. The thickness of the RNFL is always a reflection of the number of the RNFs in any particular area of the retina. Each single RNF runs a long course starting from the cell body which is the retinal ganglion cell in the retina and ends in the thalamus of the brain where it relays visual information to other nerve cell in the thalamus. Along this long course RNFs are in close anatomical relationship with the pituitary gland crossing just above this gland about midway along their course. Hence enlargement of this gland can interfere with the RNFs.
Detailed description
The inferior chiasmal syndrome is known to be caused by pituitary gland enlightenment because the pituitary gland lies just below the optic chiasma. The visual RNFs are organized in a very specific way along their long course from the retina to the Lateral Geniculate Body (LGB) in the thalamus. Pituitary enlargement would compromise particular RNFs. It is well known and established that pituitary enlargement, if not properly treated in time, would possibly cause bitemporal hemianopia due to interference with the crossing RNFs of the nasal half of each retina. In this study pituitary enlargement was suspected by OCT findings while the patient still had perfect peripheral visual field in each eye.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patient who presents with frequent or persistent headache of unknown reason.
Key inclusion criteria (1 listed)
- healthy patients with frequent or persistent headache of unknown reasons.
Key exclusion criteria (1 listed)
- patients who were previously diagnosed with or treated from pituitary enlargement
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 |
|---|---|---|
| Optical Coherence Tomography (OCT)OCT is used to measure thickness (numbers) of retinal nerve fibres in different areas of the retina | Diagnostic test | – |
Primary outcome
Thinning of the retinal nerve fibers (RNF) that are nearest to the pituitary gland, measured in micro-millimeters in OCT, were the first indication of possible enlargement of this gland.
Time frame: through study completion, an average of one year.
Pituitary gland enlargement if not treated in time can have devastating effects on vision. Early diagnosis and treatment of this problem can not be over stressed. This study describes thinning of particular RNF in each eye that led to the suspicion of pituitary enlargement and was an early sign of the inferior chiasmal syndrome. Imaging studies were used to validate the suspected result.
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 22 Mar 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.
Shawkat S Michel, FRCS Ed principal investigator
Dr. S.S. Michel Clinic
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 Mass and Diagnoses Disease, run by Dr. S.S. Michel Clinic at 1 site in Canada.
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 22 Mar 2017. 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 Canada. 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?
Thinning of the retinal nerve fibers (RNF) that are nearest to the pituitary gland, measured in micro-millimeters in OCT, were the first indication of possible enlargement of this gland. (time frame: through study completion, an average of one year.). 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 22 Mar 2017.