GlaucomaNCT02356094
Posterior Cornea in Primary Open Angle Glaucoma
An observational study of Glaucoma, run by Centro Hospitalar do Baixo Vouga at 1 site in Portugal.
Trial summary
Characterization of posterior corneal changes in primary open angle glaucoma patients, using Scheimpflug examination. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Pentacam
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 sitePortugal
- Study dates
- Jan 2015to Apr 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cases from the Glaucoma Outpatient Clinic and controls from the General Ophthalmology Outpatient Clinic from a single ophthalmological center.
Who may be able to join
- Primary open angle glaucoma, with the diagnosis supported on structural and functional complementary exams according to the current European Glaucoma Society guidelines
- Healthy subjects from the General Ophthalmology Outpatient Clinic
Who cannot join
- age inferior to 18 years old
- primary closed angle glaucoma
- secondary open angle glaucoma
- previous intra-ocular surgery
- known or suspected corneal disease
- previous intra-ocular inflammation
- previous ocular trauma
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Centro Hospitalar Baixo Vouga
Aveiro, Aveiro District, 3814-501
Pedro Gil, MSc, MD, 00351234378300, sec-geral@hdaveiro.min-saude.pt
Rita Matos, MSc, MD, 00351914452190, rita9matos@hotmail.com
About this study
Characterization of posterior corneal changes in primary open angle glaucoma patients, using Scheimpflug examination.
Read the detailed description
A cohort of primary open angle glaucoma (POAG) patients is submitted to Scheimpflug Pentacam examination. The results are compared with a control group of age and central corneal thickness matched healthy subjects
- Conditions
- Glaucoma
- Being tested
- Pentacam
- Keywords
- glaucoma, primary open angle glaucoma, cornea
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PentacamProcedure or surgery
Corneal topography using Scheimpflug Pentacam examination
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients with primary open angle glaucoma, randomly selected from the Glaucoma Outpatient Clinic to be submitted to Pentacam examination Receives: Procedure: Pentacam | |
| Controls | Control group of age and central corneal thickness matched healthy subjects, randomly selected from the General Ophthalmology Outpatient Clinic to be submitted to Pentacam examination Receives: Procedure: Pentacam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean posterior corneal elevation
Mean posterior corneal elevation based on the relative elevation of the cornea related with the best-fit sphere
Measured: Single point in time, at baseline at the moment of study enrollment
Secondary outcomes (1)
Mean anterior corneal elevation
Mean anterior corneal elevation based on the relative elevation of the cornea related with the best-fit sphere
Measured: Single point in time, at baseline at the moment of study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar do Baixo Vouga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Gil, Centro Hospitalar do Baixo Vouga
- Investigators
- Pedro Gil, MSc, MD, Principal investigator, Centro Hospitalar Baixo Vouga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356094
- Sponsor's protocol ID
- CHBaixoVouga2
- Status last verified
- Feb 2015
- First submitted
- 1 Feb 2015
- Last updated
- 5 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Arranz-Marquez E, Bolivar G, Pinero DP, Konstas AG, Mikropoulos DG, Teus MA. Orbscan topography in primary open-angle glaucoma. Optom Vis Sci. 2013 Oct;90(10):1098-103. doi: 10.1097/OPX.0000000000000019.
PubMed 23939294
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Cornea in Primary Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT02356094
- Acronym / sponsor ID
- CHBaixoVouga2
- Conditions
- Glaucoma
- Keywords
- glaucoma, primary open angle glaucoma, cornea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centro Hospitalar do Baixo VougaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 5 Feb 2015 (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.
Characterization of posterior corneal changes in primary open angle glaucoma patients, using Scheimpflug examination.
Detailed description
A cohort of primary open angle glaucoma (POAG) patients is submitted to Scheimpflug Pentacam examination. The results are compared with a control group of age and central corneal thickness matched healthy subjects
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Procedure: PentacamPatients with primary open angle glaucoma, randomly selected from the Glaucoma Outpatient Clinic to be submitted to Pentacam examination |
| Controls | – | Procedure: PentacamControl group of age and central corneal thickness matched healthy subjects, randomly selected from the General Ophthalmology Outpatient Clinic to be submitted to Pentacam examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cases from the Glaucoma Outpatient Clinic and controls from the General Ophthalmology Outpatient Clinic from a single ophthalmological center.
Key inclusion criteria (2 listed)
- Primary open angle glaucoma, with the diagnosis supported on structural and functional complementary exams according to the current European Glaucoma Society guidelines
- Healthy subjects from the General Ophthalmology Outpatient Clinic
Key exclusion criteria (7 listed)
- age inferior to 18 years old
- primary closed angle glaucoma
- secondary open angle glaucoma
- previous intra-ocular surgery
- known or suspected corneal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PentacamCorneal topography using Scheimpflug Pentacam examination | Procedure or surgery | Cases, Controls |
Primary outcome
Mean posterior corneal elevation
Time frame: Single point in time, at baseline at the moment of study enrollment
Mean posterior corneal elevation based on the relative elevation of the cornea related with the best-fit sphere
1 secondary outcome
Mean anterior corneal elevation
Time frame: Single point in time, at baseline at the moment of study enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2015.
- Results publication: PubMed 23939294Arranz-Marquez E, Bolivar G, Pinero DP, Konstas AG, Mikropoulos DG, Teus MA. Orbscan topography in primary open-angle glaucoma. Optom Vis Sci. 2013 Oct;90(10):1098-103. doi: 10.1097/OPX.0000000000000019.
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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.
Pedro Gil, MSc, MD principal investigator
Centro Hospitalar Baixo Vouga
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 Centro Hospitalar do Baixo Vouga at 1 site in Portugal.
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 2 inclusion and 7 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 5 Feb 2015. 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 Portugal. 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?
Contact Pedro Gil, MSc, MD (00351915687941, pedroqgil@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean posterior corneal elevation (time frame: Single point in time, at baseline at the moment of study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02356094, which also lists 1 linked publication.
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 5 Feb 2015.