A-Mode vs PalmScan Ultrasonography: Biometric Measurements.

This study has been completed.

Sponsor:

Information provided by:

Asociación para Evitar la Ceguera en México

ClinicalTrials.gov Identifier:

NCT00804869

First received: December 3, 2008

Last updated: December 6, 2008

Last verified: December 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	December 3, 2008
Last Updated Date	December 6, 2008
Start Date ^ICMJE	October 2008
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 6, 2008)	axial length (AL). [ Time Frame: during examination ] [ Designated as safety issue: No ] Anterior Chamber Deep (ACD) [ Time Frame: during examination ] [ Designated as safety issue: No ] Lens Thickness (LT) [ Time Frame: during examination ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00804869 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A-Mode vs PalmScan Ultrasonography: Biometric Measurements.
Official Title ^ICMJE	Standard A-Mode Ultrasonography vs PalmScan Ultrasonography: Biometric Measurements.
Brief Summary	Ultrasonography has become a critical ancillary test in the clinical practice of ophthalmology. It is commonly used as a standardized method for assessing intraocular biometry. The PalmScan ultrasonography (PsU) is a portable A-scan device that uses the same principles as the standard A-scan. The aim of the study is to compare the reliability of their measurements, in order to use them indistinctively.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	All patients who need axial length calculation.
Condition ^ICMJE	Axial Length (AL) Anterior Chamber Deep (ACD) Lens Thickness (LT)
Intervention ^ICMJE	Device: PalmScan A2000 ultrasonography system (Micro Medical Devices, Calabasas, CA) PalmScan biometric measurements Device: Standard A-mode ultrasound (Eye Cubed™, Ellex, Adelaide, Australia). A-mode biometric measurements group
Study Group/Cohort (s)	1 PalmScan biometric group Intervention: Device: PalmScan A2000 ultrasonography system (Micro Medical Devices, Calabasas, CA) 2 A-mode ultrasonography biometric group Intervention: Device: Standard A-mode ultrasound (Eye Cubed™, Ellex, Adelaide, Australia).
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients with indication for a standard A-mode ultrasound Exclusion Criteria: No superficial anormalities. Patients with external injuries. Intraocular silicon oil. Retinal detachment Significant ocular pathologies.
Gender	Both
Ages	50 Years to 90 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Mexico

Administrative Information
NCT Number ^ICMJE	NCT00804869
Other Study ID Numbers ^ICMJE	APEC-037
Has Data Monitoring Committee	Yes
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Asociación para Evitar la Ceguera en México
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Asociación para Evitar la Ceguera en México
Verification Date	December 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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