NCT02356094

Brief Summary

Characterization of posterior corneal changes in primary open angle glaucoma patients, using Scheimpflug examination.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 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

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 1, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

February 5, 2015

Status Verified

February 1, 2015

Enrollment Period

3 months

First QC Date

February 1, 2015

Last Update Submit

February 1, 2015

Conditions

Keywords

glaucomaprimary open angle glaucomacornea

Outcome Measures

Primary Outcomes (1)

  • Mean posterior corneal elevation

    Mean posterior corneal elevation based on the relative elevation of the cornea related with the best-fit sphere

    Single point in time, at baseline at the moment of study enrollment

Secondary Outcomes (1)

  • Mean anterior corneal elevation

    Single point in time, at baseline at the moment of study enrollment

Study Arms (2)

Cases

Patients with primary open angle glaucoma, randomly selected from the Glaucoma Outpatient Clinic to be submitted to Pentacam examination

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

Procedure: Pentacam

Interventions

PentacamPROCEDURE

Corneal topography using Scheimpflug Pentacam examination

CasesControls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cases from the Glaucoma Outpatient Clinic and controls from the General Ophthalmology Outpatient Clinic from a single ophthalmological center.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Hospitalar Baixo Vouga

Aveiro, Aveiro District, 3814-501, Portugal

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

GlaucomaGlaucoma, Open-AngleCorneal Diseases

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Pedro Gil, MSc, MD

    Centro Hospitalar Baixo Vouga

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro Gil, MSc, MD

CONTACT

João Gil, MSc, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pedro Gil, MSc, MD

Study Record Dates

First Submitted

February 1, 2015

First Posted

February 5, 2015

Study Start

January 1, 2015

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

February 5, 2015

Record last verified: 2015-02

Locations