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Agreement Between Spectral Domain and Time Domain Optical Coherence Tomography (OCT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by G. d'Annunzio University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
G. d'Annunzio University
ClinicalTrials.gov Identifier:
NCT00651989
First received: March 28, 2008
Last updated: April 2, 2008
Last verified: March 2008

March 28, 2008
April 2, 2008
April 2008
May 2008   (final data collection date for primary outcome measure)
foveal thickness [ Time Frame: at subject enrollment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00651989 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Agreement Between Spectral Domain and Time Domain Optical Coherence Tomography (OCT)
Agreement in Foveal Thickness Measurements Between Spectralis® and Stratus® Optical Coherence Tomography

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

volounteer students and employers from the Clinic staff

Normal Foveal Thickness
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
A
healthy individuals
Intervention: Other: optical coherence tomography foveal thickness measurement
Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
May 2008
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy subjects

Exclusion Criteria:

  • any systemic or eye disease
  • previous ocular surgery or laser treatment
  • any systemic or ocular therapy
Both
19 Years to 30 Years
Yes
Contact: Paolo Carpineto, M.D. +39 0871 358489 p.carpineto@unich.it
Contact: Mario Nubile, M.D. +39 0871 358489 m.nubile@unich.it
Italy
 
NCT00651989
Ud'A-Ophtha-001
Yes
Paolo Carpineto M.D., Dept. of Medicine and Aging Sciences, University "G. d'Annunzio" Chieti-Pescara
G. d'Annunzio University
Not Provided
Principal Investigator: Paolo Carpineto, M.D. Dept. of Medicine and Aging Sciences, Univ. "G. d'Annunzio" Chieti-Pescara
G. d'Annunzio University
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP