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Myocilin Variations and Familial Glaucoma in Taxiarchis (Taxiarchis)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2014 by AGP Konstas, Aristotle University Of Thessaloniki.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00788762
First Posted: November 11, 2008
Last Update Posted: May 12, 2014
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.
Information provided by (Responsible Party):
AGP Konstas, Aristotle University Of Thessaloniki
  Purpose
Taxiarchis, a small village in Northern Greece with 1060 inhabitants, was considered to have a surprisingly high incidence of glaucoma. This isolated population located on Mount Holomondas appeared to be enriched for familial glaucoma. Based upon the high reported incidence of glaucoma in Taxiarchis and previous findings of the Thr377Met myocilin mutation in the Greek population,the investigators undertook a community-based study to determine if this variant was present in this village.

Condition
Glaucoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Myocilin Variations and Familial Glaucoma in Taxiarchis, A Small Greek Village.

Resource links provided by NLM:


Further study details as provided by AGP Konstas, Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • Examining all of the villagers to determine the actual incidence of glaucoma in Taxiarchis and identify the Thr377Met myocilin mutation in glaucoma patients. [ Time Frame: 4 years ]

Biospecimen Retention:   Samples With DNA
Myocilin screening was performed from blood or saliva specimens taken from the village. The promoter region and exons 1-3 of myocilin were sequenced at the Portland Veterans Administration Medical center. Microsatellite marker analysis in the GLC1A region, including D1S452, D1S1619, D1S2790 and D1S242 was performed at deCODE (Reykjavik, Iceland).

Estimated Enrollment: 800
Study Start Date: August 2007
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Villagers in Taxiarchis

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Villagers from Taxiarchis
Criteria

Inclusion Criteria:

  • Individuals born in Taxiarchis

Exclusion Criteria:

  • Individuals that have not been born in Taxiarchis
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00788762


Contacts
Contact: Anastasios G Konstas, MD, PhD 2310-994774 konstas@med.auth.gr
Contact: Georgios Moumtzis, MD 2310-994742

Locations
Greece
Taxiarchis village Recruiting
Polygyros, Halkidiki, Greece
Sub-Investigator: Antonios Dimopoulos, MD         
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
Principal Investigator: Anastasios G Konstas, MD, PhD Glaucoma Unit, 1st University Dept
  More Information

Responsible Party: AGP Konstas, Professor in Ophthalmology, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT00788762     History of Changes
Other Study ID Numbers: A6798
First Submitted: November 7, 2008
First Posted: November 11, 2008
Last Update Posted: May 12, 2014
Last Verified: May 2014

Keywords provided by AGP Konstas, Aristotle University Of Thessaloniki:
glaucoma
myocilin

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases