Pituitary Gland Enlargement Was First Diagnosed by Optical Coherence Tomography (OCT)
OCT
1 other identifier
observational
2
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 12, 2017
CompletedFirst Posted
Study publicly available on registry
March 22, 2017
CompletedMarch 22, 2017
March 1, 2017
1.1 years
March 12, 2017
March 21, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
through study completion, an average of one year.
Interventions
OCT is used to measure thickness (numbers) of retinal nerve fibres in different areas of the retina
Eligibility Criteria
Any patient who presents with frequent or persistent headache of unknown reason.
You may qualify if:
- healthy patients with frequent or persistent headache of unknown reasons.
You may not qualify if:
- patients who were previously diagnosed with or treated from pituitary enlargement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr. S.S. Michel Clinic
Edmonton, Alberta, T5R5W9, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shawkat S Michel, FRCS Ed
Dr. S.S. Michel Clinic
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 12, 2017
First Posted
March 22, 2017
Study Start
February 1, 2013
Primary Completion
March 15, 2014
Study Completion
August 1, 2016
Last Updated
March 22, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share