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Myocilin Variations and Familial Glaucoma in Taxiarchis

This study is currently recruiting participants.
Verified January 2013 by Aristotle University Of Thessaloniki
Sponsor:
Information provided by (Responsible Party):
AGP Konstas, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT00788762
First received: November 7, 2008
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  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:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

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 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Villagers in Taxiarchis

  Eligibility

Ages Eligible for Study:   1 Year to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: AGP Konstas, Professor in Ophthalmology, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT00788762     History of Changes
Other Study ID Numbers: A6798
Study First Received: November 7, 2008
Last Updated: January 25, 2013
Health Authority: Greece: National Organization of Medicines

Keywords provided by Aristotle University Of Thessaloniki:
glaucoma
myocilin

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on May 21, 2013