- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03087682
Pituitary Gland Enlargement Was First Diagnosed by Optical Coherence Tomography (OCT) (OCT)
March 21, 2017 updated by: Dr. Shawkat Michel, Dr. S.S. Michel Clinic
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Alberta
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Edmonton, Alberta, Canada, T5R5W9
- Dr. S.S. Michel Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Any patient who presents with frequent or persistent headache of unknown reason.
Description
Inclusion Criteria:
- healthy patients with frequent or persistent headache of unknown reasons.
Exclusion Criteria:
- patients who were previously diagnosed with or treated from pituitary enlargement
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
through study completion, an average of one year.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: shawkat s michel, FRCS Ed, Dr. S.S. Michel Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2013
Primary Completion (Actual)
March 15, 2014
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
March 12, 2017
First Submitted That Met QC Criteria
March 21, 2017
First Posted (Actual)
March 22, 2017
Study Record Updates
Last Update Posted (Actual)
March 22, 2017
Last Update Submitted That Met QC Criteria
March 21, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pituitary gland enlargement
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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