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Pituitary Gland Enlargement Was First Diagnosed by Optical Coherence Tomography (OCT) (OCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03087682
Recruitment Status : Completed
First Posted : March 22, 2017
Last Update Posted : March 22, 2017
Information provided by (Responsible Party):
Dr. Shawkat Michel, Dr. S.S. Michel Clinic

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.

Condition or disease Intervention/treatment
Pituitary Mass Diagnoses Disease Diagnostic Test: Optical Coherence Tomography (OCT)

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.

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Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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
Actual Study Start Date : February 1, 2013
Actual Primary Completion Date : March 15, 2014
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

Intervention Details:
  • Diagnostic Test: Optical Coherence Tomography (OCT)
    OCT is used to measure thickness (numbers) of retinal nerve fibres in different areas of the retina

Primary Outcome Measures :
  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. [ 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Any patient who presents with frequent or persistent headache of unknown reason.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03087682

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Canada, Alberta
Dr. S.S. Michel Clinic
Edmonton, Alberta, Canada, T5R5W9
Sponsors and Collaborators
Dr. S.S. Michel Clinic
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Principal Investigator: Shawkat S Michel, FRCS Ed Dr. S.S. Michel Clinic

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Responsible Party: Dr. Shawkat Michel, Principal Investigator, Dr. S.S. Michel Clinic Identifier: NCT03087682     History of Changes
Other Study ID Numbers: Pituitary gland enlargement
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Pathological Conditions, Anatomical