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

Normal Foveal Thickness Clinical Trial

Official title:

Agreement in Foveal Thickness Measurements Between Spectralis® and Stratus® Optical Coherence Tomography

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00651989
• Other study ID #: Ud'A-Ophtha-001
• Status: Not yet recruiting
• Phase: N/A
• First received: March 28, 2008
• Last updated: April 2, 2008
• Start date: April 2008
• Est. completion date: May 2008

Study information

• Verified date: March 2008
• Source: G. d'Annunzio University
• Contact: Paolo Carpineto, M.D.
• Phone: +39 0871 358489
• Email: p.carpineto[@]unich.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 30 Years

Eligibility

Inclusion Criteria:

• healthy subjects

Exclusion Criteria:

• any systemic or eye disease

• previous ocular surgery or laser treatment

• any systemic or ocular therapy

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Normal Foveal Thickness

Intervention

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.

Locations

Country	Name	City	State
Italy	Ophthalmology Clinic, Univ. "G. d'Annunzio" Chieti-Pescara	Chieti

Sponsors (1)

Lead Sponsor	Collaborator
G. d'Annunzio University

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	foveal thickness		at subject enrollment	No