Agreement Between Spectral Domain and Time Domain Optical... | NCT00651989

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

NCT00651989

Sponsor

G. d'Annunzio University

Status

Unknown status

Last Update Posted

Apr 3, 2008Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Normal Foveal Thickness

Interventions

optical coherence tomography foveal thickness measurement

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

May 2008Estimated

Completion Date

May 2008Estimated

First Submitted Date

Mar 28, 2008

First Submission Date that Met QC Criteria

Apr 2, 2008

First Posted Date

Apr 3, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2008

Last Update Posted Date

Apr 3, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A		healthy individuals	Other: optical coherence tomography foveal thickness measurement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
optical coherence tomography foveal thickness measurement	Other	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.

Measure	Description	Time Frame
foveal thickness		at subject enrollment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy subjects

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

volounteer students and employers from the Clinic staff

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Paolo Carpineto, M.D.	Contact	+39 0871 358489		p.carpineto@unich.it
Mario Nubile, M.D.	Contact	+39 0871 358489		m.nubile@unich.it

Overall Officials

Name	Affiliation	Role
Paolo Carpineto, M.D.	Dept. of Medicine and Aging Sciences, Univ. "G. d'Annunzio" Chieti-Pescara	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ophthalmology Clinic, Univ. "G. d'Annunzio" Chieti-Pescara		Chieti		66100	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
2868172	Background	Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.