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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03087682
Other study ID # Pituitary gland enlargement
Secondary ID
Status Completed
Phase N/A
First received March 12, 2017
Last updated March 21, 2017
Start date February 1, 2013
Est. completion date August 2016

Study information

Verified date March 2017
Source Dr. S.S. Michel Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 2
Est. completion date August 2016
Est. primary completion date March 15, 2014
Accepts healthy volunteers No
Gender All
Age group 15 Years to 65 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Canada Dr. S.S. Michel Clinic Edmonton Alberta

Sponsors (1)

Lead Sponsor Collaborator
Dr. S.S. Michel Clinic

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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