NCT00927303

Brief Summary

Retinal thickness measurement is one of the most important examinations in the follow up of exudative age-related macular degeneration. Prior studies have shown that there are a series of algorithm line failures in OCT examinations. This study is conducted to compare the quality of the examinations of to different spectral domain OCT machines concerning the positioning of algorithm lines. Furthermore the reproducibility of the examinations id tested, both machines provide different techniques to guarantee that in repeated examinations the same location is examined.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2009

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

June 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 24, 2009

Completed
7 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 9, 2010

Status Verified

June 1, 2010

Enrollment Period

5 months

First QC Date

June 23, 2009

Last Update Submit

June 8, 2010

Conditions

Exudative Age Related Macular Degeneration

Keywords

retinal thicknessthreshold algorithmoptical coherence tomography

Outcome Measures

Primary Outcomes (1)

  • Number of examinations with correctly set threshold algorithm lines

    1 day

Secondary Outcomes (5)

  • Differences of mean retinal thickness in the central region

    1 day

  • Differences of retinal volume

    1 day

  • Distance acuity

    1 day

  • Age

    1 day

  • Classification of the lesion

    1 day

Study Arms (8)

Group 1

Intervention 1 Sequence of observers: observer1, observer 2, observer 1, observer 2

Device: Cirrus-Spectralis

group 2

intervention 1 sequence of observers: observer 2, observer 1, observer 2, observer 1

Device: Cirrus-Spectralis

group 3

intervention 2 sequence of observers: 1,2,1,2

Device: Spectralis-Cirrus

group 4

intervention 2 sequence of observers: 2,1,2,1

Device: Spectralis-Cirrus

group 5

intervention 1 sequence of observers 1,1,2,2

Device: Cirrus-Spectralis

group 6

intervention 1 sequence of observers 2,2,1,1

Device: Cirrus-Spectralis

group 7

intervention 2 sequence of observers: 1,1,2,2

Device: Spectralis-Cirrus

group 8

intervention 2 sequence of observers: 2,2,1,1

Device: Spectralis-Cirrus

Interventions

Cirrus-SpectralisDEVICE

512x128 cúbe program of Cirrus OCT first retinal volume 121 line of Spectralis OCT thereafter

Group 1group 2group 5group 6
Spectralis-CirrusDEVICE

retinal volume program 121 lines Spectralis OCT first 512x128 program Cirrus OCT thereafter

group 3group 4group 7group 8

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

male or female persons aged more than 50 years with exudative age related macular degeneration

You may qualify if:

  • Exudative age related macular degeneration

You may not qualify if:

  • Macular pathologies other than age related macular degeneration (diabetic maculopathy, macular pucker, macular hole,
  • Visualization of the macula not possible (dens cataract, vitreous haemorrhage)
  • Not consented patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery

Vienna, Vienna, 1030, Austria

Location

Related Publications (1)

  • Krebs I, Smretschnig E, Moussa S, Brannath W, Womastek I, Binder S. Quality and reproducibility of retinal thickness measurements in two spectral-domain optical coherence tomography machines. Invest Ophthalmol Vis Sci. 2011 Sep 1;52(9):6925-33. doi: 10.1167/iovs.10-6612.

    PMID: 21791591DERIVED

Biospecimen

Retention: NONE RETAINED

male or femal persons age over 50 years with exudative age-related macular degeneration

Study Officials

  • Susanne Binder, MD, Prof

    Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 23, 2009

First Posted

June 24, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

June 9, 2010

Record last verified: 2010-06

Locations

AU(1)