Clinical trial NCT00651989: Agreement Between Spectral Domain and Time Domain Optical Coherence Tomography (OCT)
Official title: Agreement in Foveal Thickness Measurements Between Spectralis® and Stratus® Optical Coherence Tomography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Normal Foveal Thickness
Keywords: optical coherence tomography
spectral domain
time domain
Lead sponsor: G. d'Annunzio University
Sponsor class: OTHER
First posted: 2008-04-03
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: volounteer students and employers from the Clinic staff

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* any systemic or eye disease
* previous ocular surgery or laser treatment
* any systemic or ocular therapy

Primary outcomes:
measure: foveal thickness
timeFrame: at subject enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: Ophthalmology Clinic, Univ. "G. d'Annunzio" Chieti-Pescara
Study officials:
affiliation: Dept. of Medicine and Aging Sciences, Univ. "G. d'Annunzio" Chieti-Pescara
name: Paolo Carpineto, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.