NCT00873106

Brief Summary

The purpose of the present study is to determine if the retinal thickness estimates of the Stratus OCT, the 3D OCT-1000, and the CirrusHD OCT are comparable in diabetic and in healthy individuals (OCT=Optical Coherence Tomography).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
completed

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, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2009

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

September 6, 2012

Status Verified

September 1, 2012

Enrollment Period

1.1 years

First QC Date

March 18, 2009

Last Update Submit

September 5, 2012

Conditions

HealthyDiabetic Maculopathy

Outcome Measures

Primary Outcomes (1)

  • Retinal thickness and retinal volume from each OCT scan

    within 24 hours

Interventions

Optical coherence tomographyDEVICE

Stratus OCT: fast radial lines 3D OCT-1000: radial 2048 and 3D OCT Cirrus HD OCT: 3D OCT

Eligibility Criteria

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

A group of diabetic and healthy participants

You may qualify if:

  • diabetic retinopathy in the diabetic group
  • healthy retinas in the healthy group

You may not qualify if:

  • not able to cooperate
  • retinal disease other than macular oedema
  • severe media opacities (e.g. cataract)
  • prior macular laser photocoagulation except for large oedemas

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Glostrup Hospital, University of Copenhagen, Nordre Ringvej 57

Glostrup Municipality, Copenhagen, DK-2600, Denmark

Location

MeSH Terms

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Dorte Nellemann Thornit, MD

    Department of Ophthalmology, Glostrup Hospital, University of Copenhagen, Nordre Ringvej 57, DK-2600 Glostrup, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ph.d

Study Record Dates

First Submitted

March 18, 2009

First Posted

April 1, 2009

Study Start

February 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

September 6, 2012

Record last verified: 2012-09

Locations

DK(1)