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A-Mode vs PalmScan Ultrasonography: Biometric Measurements.

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ClinicalTrials.gov Identifier: NCT00804869
Recruitment Status : Completed
First Posted : December 9, 2008
Last Update Posted : December 9, 2008
Sponsor:
Information provided by:
Asociación para Evitar la Ceguera en México

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.

Condition or disease Intervention/treatment
Axial Length (AL) Anterior Chamber Deep (ACD) Lens Thickness (LT) Device: PalmScan A2000 ultrasonography system (Micro Medical Devices, Calabasas, CA) Device: Standard A-mode ultrasound (Eye Cubed™, Ellex, Adelaide, Australia).

Study Type : Observational
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Standard A-Mode Ultrasonography vs PalmScan Ultrasonography: Biometric Measurements.
Study Start Date : October 2008
Actual Primary Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Group/Cohort Intervention/treatment
1
PalmScan biometric group
Device: PalmScan A2000 ultrasonography system (Micro Medical Devices, Calabasas, CA)
PalmScan biometric measurements
2
A-mode ultrasonography biometric group
Device: Standard A-mode ultrasound (Eye Cubed™, Ellex, Adelaide, Australia).
A-mode biometric measurements group



Primary Outcome Measures :
  1. axial length (AL). [ Time Frame: during examination ]
  2. Anterior Chamber Deep (ACD) [ Time Frame: during examination ]
  3. Lens Thickness (LT) [ Time Frame: during examination ]


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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All patients who need axial length calculation.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00804869


Locations
Mexico
Asociación para Evitar la Ceguera en México
Mexico, DF, Mexico, 04030
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México

ClinicalTrials.gov Identifier: NCT00804869     History of Changes
Other Study ID Numbers: APEC-037
First Posted: December 9, 2008    Key Record Dates
Last Update Posted: December 9, 2008
Last Verified: December 2008