Agreement Between Spectral Domain and Time Domain Optical Coherence Tomography (OCT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00651989|
Recruitment Status : Unknown
Verified March 2008 by G. d'Annunzio University.
Recruitment status was: Not yet recruiting
First Posted : April 3, 2008
Last Update Posted : April 3, 2008
Optical coherence tomography (OCT) is a well-established and safe technique that offers the possibility of visualizing retinal structure and measuring retinal thickness. Time-domain (TD)OCT is considered the "gold standard" technique for retinal thickness measurements. Spectral-domain (SD) OCT has to face the gold standard technique prior to obtain scientific and clinical consensus.
In our study in healthy subjects foveal thickness will be measured with both TD and SD OCT , and the data will be compared to evidence any difference between the two retinal measurements techniques.
|Condition or disease||Intervention/treatment|
|Normal Foveal Thickness||Other: optical coherence tomography foveal thickness measurement|
The study will be performed at the Ophthalmology Clinic of the University of Chieti-Pescara, Italy. Forty healthy individuals will be enrolled in this study. In the same session in one randomly selected eye of each subject three consecutive measurements of foveal thickness will be performed using both TD OCT and FD OCT. All measurements will be obtained by the same experienced examinator.
Time domain optical coherence tomography images will be obtained from each eye after pupil dilation using the Stratus OCT system (version 4.1. Carl Zeiss Meditec, Dublin, CA).
Spectral domain optical coherence tomography images will be obtained using the HRA-OCT Spectralis unit (Heidelberg Engineering GmbH, Heidelberg, Germany).
All data will be analyzed with the statistical package MedCalc® version 8.1 for Windows (MedCalc®, Mariakerke, Belgium).
The D'Agostino-Pearson test that computes a single P-value for the combination of the coefficients of Skewness and Kurtosis will be used to study the sample distribution.
T-test will be used to compare means between Stratus and Spectralis measurements and orizontal and vertical measurements.
To assess agreement between Spectralis and Stratus OCT foveal measurements the Bland and Altman plots of the agreement in foveal thickness will be used. For both orizontal and vertical foveal measurements the ratio (Spectralis/stratus OCT foveal thickness) will be plotted against the average of the two measurements.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Agreement in Foveal Thickness Measurements Between Spectralis® and Stratus® Optical Coherence Tomography|
|Study Start Date :||April 2008|
|Estimated Primary Completion Date :||May 2008|
|Estimated Study Completion Date :||May 2008|
Other: optical coherence tomography foveal thickness measurement
In the same session in one randomly selected eye of each subject three consecutive measurements of foveal thickness were performed using both time-domain OCT and spectral-domain OCT.
Other Name: healthy subjects
- foveal thickness [ Time Frame: at subject enrollment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00651989
|Contact: Paolo Carpineto, M.D.||+39 0871 email@example.com|
|Contact: Mario Nubile, M.D.||+39 0871 firstname.lastname@example.org|
|Ophthalmology Clinic, Univ. "G. d'Annunzio" Chieti-Pescara||Not yet recruiting|
|Chieti, Italy, 66100|
|Principal Investigator: Paolo Carpineto, M.D.|
|Principal Investigator:||Paolo Carpineto, M.D.||Dept. of Medicine and Aging Sciences, Univ. "G. d'Annunzio" Chieti-Pescara|