The Spectralis-Cirrus Study

NCT ID: NCT00927303

Last Updated: 2010-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2009-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Exudative Age Related Macular Degeneration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

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

Cirrus-Spectralis

Intervention Type DEVICE

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

group 2

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

Cirrus-Spectralis

Intervention Type DEVICE

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

group 3

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

Spectralis-Cirrus

Intervention Type DEVICE

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

group 4

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

Spectralis-Cirrus

Intervention Type DEVICE

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

group 5

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

Cirrus-Spectralis

Intervention Type DEVICE

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

group 6

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

Cirrus-Spectralis

Intervention Type DEVICE

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

group 7

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

Spectralis-Cirrus

Intervention Type DEVICE

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

group 8

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

Spectralis-Cirrus

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cirrus-Spectralis

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

Intervention Type DEVICE

Spectralis-Cirrus

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Exudative age related macular degeneration

Exclusion Criteria

* 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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Susanne Binder, MD, Prof

Role: STUDY_CHAIR

Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery

Vienna, Vienna, Austria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 21791591 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

09-086-0609

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

High Resolution Imaging OCT Study
NCT07338461 NOT_YET_RECRUITING NA