NCT01299233

Brief Summary

To assess the improvement in reproducibility of 100 vs. 16 averaged images by Automatic Real Time (ART) using Spectralis™ Spectral Domain-Optical Coherence Tomography (SD-OCT, Heidelberg Engineering GmbH, Heidelberg, Germany) in retinal nerve fiber layer thickness (RNFL) circle scan-measurements.

  • Trial with medical device

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 Feb 2011

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

February 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2011

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 6, 2015

Status Verified

December 1, 2014

Enrollment Period

4.8 years

First QC Date

February 16, 2011

Last Update Submit

January 5, 2015

Conditions

Glaucoma Patients and Healthy Controls

Outcome Measures

Primary Outcomes (1)

  • COV

    T0

Study Arms (2)

control group

age matched healthy controls

Device: Spectralis® SD-OCT, Heidelberg Engineering GmbH, H

Glaucoma

patients with diagnosis of primary open angle glaucoma

Device: Spectralis® SD-OCT, Heidelberg Engineering GmbH, H

Interventions

Spectralis® SD-OCT, Heidelberg Engineering GmbH, HDEVICE

Measurement of the peripapillar nerve fiber layer with different settings of ART

Glaucomacontrol group

Eligibility Criteria

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

patients and controls are selected out of our primary care clinic

You may qualify if:

  • for both groups (glaucoma study group and control group): men and women of at least 50 years of age
  • for the glaucoma study group: diagnosis of primary open angle glaucoma (POAG)

You may not qualify if:

  • for both groups (glaucoma study group and control group):
  • less then 18 years of age
  • any pathology of the central retina
  • any optic nerve disorder other then glaucoma
  • retinal vascular disorder
  • for the glaucoma study group: other glaucoma diagnosis then primary open angle glaucoma
  • for the control group: any diagnosis of glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Ophthalmic Clinic

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Interventions

Proton Therapy

Intervention Hierarchy (Ancestors)

Heavy Ion RadiotherapyRadiotherapyTherapeutics

Study Officials

  • Jens Funk, Prof. MD

    University Hospital Zurich, Ophtalmic Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2011

First Posted

February 18, 2011

Study Start

February 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 6, 2015

Record last verified: 2014-12

Locations

CH(1)