NCT00788762

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
840

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 11, 2008

Completed
14.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

15.3 years

First QC Date

November 7, 2008

Last Update Submit

December 16, 2020

Conditions

Glaucoma

Keywords

glaucomamyocilin

Outcome Measures

Primary Outcomes (1)

  • Examining all of the villagers to determine the actual incidence of glaucoma in Taxiarchis and identify the Thr377Met myocilin mutation in glaucoma patients.

    4 years

Study Arms (1)

Villagers in Taxiarchis

Eligibility Criteria

Age1 Year - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Villagers from Taxiarchis

You may qualify if:

  • Individuals born in Taxiarchis

You may not qualify if:

  • Individuals that have not been born in Taxiarchis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taxiarchis village

Polygyros, Halkidiki, Greece

Location

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).

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Anastasios G Konstas, MD, PhD

    Glaucoma Unit, 1st University Dept

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Ophthalmology

Study Record Dates

First Submitted

November 7, 2008

First Posted

November 11, 2008

Study Start

August 1, 2007

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

December 17, 2020

Record last verified: 2020-12

Locations

GR(1)