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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
  Purpose

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 Intervention
Normal Foveal Thickness
Other: optical coherence tomography foveal thickness measurement

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Agreement in Foveal Thickness Measurements Between Spectralis® and Stratus® Optical Coherence Tomography

Further study details as provided by G. d'Annunzio University:

Primary Outcome Measures:
  • foveal thickness [ Time Frame: at subject enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2008
Estimated Study Completion Date: May 2008
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A
healthy individuals
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

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

Ages Eligible for Study:   19 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

volounteer students and employers from the Clinic staff

Criteria

Inclusion Criteria:

  • healthy subjects

Exclusion Criteria:

  • any systemic or eye disease
  • previous ocular surgery or laser treatment
  • any systemic or ocular therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651989

Contacts
Contact: Paolo Carpineto, M.D. +39 0871 358489 p.carpineto@unich.it
Contact: Mario Nubile, M.D. +39 0871 358489 m.nubile@unich.it

Locations
Italy
Ophthalmology Clinic, Univ. "G. d'Annunzio" Chieti-Pescara Not yet recruiting
Chieti, Italy, 66100
Principal Investigator: Paolo Carpineto, M.D.         
Sponsors and Collaborators
G. d'Annunzio University
Investigators
Principal Investigator: Paolo Carpineto, M.D. Dept. of Medicine and Aging Sciences, Univ. "G. d'Annunzio" Chieti-Pescara
  More Information

Publications:
Responsible Party: Paolo Carpineto M.D., Dept. of Medicine and Aging Sciences, University "G. d'Annunzio" Chieti-Pescara
ClinicalTrials.gov Identifier: NCT00651989     History of Changes
Other Study ID Numbers: Ud'A-Ophtha-001
Study First Received: March 28, 2008
Last Updated: April 2, 2008
Health Authority: Italy: Ethics Committee

Keywords provided by G. d'Annunzio University:
optical coherence tomography
spectral domain
time domain

ClinicalTrials.gov processed this record on November 25, 2014