NCT02085850

Brief Summary

Aim 1: To determine the incidence of glaucoma in Ghana in subjects previously found to be non-glaucomatous in the Tema Eye Survey. Aim 2: To characterise the progression of glaucoma and the outcomes of subjects diagnosed with glaucoma in the Tema Eye Survey.

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
1,375

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2014

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

March 1, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 13, 2014

Status Verified

March 1, 2014

Enrollment Period

2 years

First QC Date

March 11, 2014

Last Update Submit

March 11, 2014

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (2)

  • Incidence of Glaucoma

    Day 0

  • Progression of Glaucoma

    Day 0

Study Arms (1)

Subjects identified in the Tema Eye Survey

Subjects identified in the Tema Eye Survey

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community sample

You may qualify if:

  • \- glaucomatous and non-glaucomatous patients previously seen in the Tema Eye Survey who are selected and invited to participate

You may not qualify if:

  • \- patients not previously seen in the Tema Eye Survey

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tema Christian Eye Center

Tema, Ghana

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Alexander Spratt, MBBCh FRCOphth

    Tema Christian Eye Center

    PRINCIPAL INVESTIGATOR

  • Donald L Budenz, MD MPH

    University of North Carolina, Chapel Hill

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 11, 2014

First Posted

March 13, 2014

Study Start

March 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 13, 2014

Record last verified: 2014-03

Locations

GH(1)