GlaucomaNCT02085850
Incidence and Progression of Glaucoma in the Tema Eye Survey Cohort
An observational study of Glaucoma, run by Tema Christian Eye Center at 1 site in Ghana.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- How many people
- 1,375 participants
- Where
- 1 siteGhana
- Study dates
- Mar 2014to Mar 2016
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community sample
Who may be able to join
- glaucomatous and non-glaucomatous patients previously seen in the Tema Eye Survey who are selected and invited to participate
Who cannot join
- patients not previously seen in the Tema Eye Survey
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Glaucoma
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects identified in the Tema Eye Survey | Subjects identified in the Tema Eye Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Glaucoma
Measured: Day 0
Progression of Glaucoma
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,375 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Tema Christian Eye Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex Spratt, Tema Christian Eye Center
- Investigators
- Alexander Spratt, MBBCh FRCOphth, Principal investigator, Tema Christian Eye CenterDonald L Budenz, MD MPH, Study chair, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085850
- Sponsor's protocol ID
- TCEC 066/13-14
- Status last verified
- Mar 2014
- First submitted
- 11 Mar 2014
- Last updated
- 13 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Progression of Glaucoma in the Tema Eye Survey Cohort
- ClinicalTrials.gov ID
- NCT02085850
- Acronym / sponsor ID
- TCEC 066/13-14
- Conditions
- Glaucoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,375 participants (estimated)
- Lead sponsor
- Tema Christian Eye CenterUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects identified in the Tema Eye Survey | – | –Subjects identified in the Tema Eye Survey |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (1 listed)
- glaucomatous and non-glaucomatous patients previously seen in the Tema Eye Survey who are selected and invited to participate
Key exclusion criteria (1 listed)
- patients not previously seen in the Tema Eye Survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Glaucoma
Time frame: Day 0
Progression of Glaucoma
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Spratt, MBBCh FRCOphth principal investigator
Tema Christian Eye Center
Donald L Budenz, MD MPH study chair
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by Tema Christian Eye Center at 1 site in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Glaucoma (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2014.