NCT03087682

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2014

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 22, 2017

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

1.1 years

First QC Date

March 12, 2017

Last Update Submit

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

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Location

MeSH Terms

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Shawkat S Michel, FRCS Ed

    Dr. S.S. Michel Clinic

    PRINCIPAL INVESTIGATOR

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

Locations