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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
  Purpose

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 Intervention
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
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Standard A-Mode Ultrasonography vs PalmScan Ultrasonography: Biometric Measurements.

Further study details as provided by Asociación para Evitar la Ceguera en México:

Primary Outcome Measures:
  • 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 ]

Study Start Date: October 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00804869

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

No publications provided

ClinicalTrials.gov Identifier: NCT00804869     History of Changes
Other Study ID Numbers: APEC-037
Study First Received: December 3, 2008
Last Updated: December 6, 2008
Health Authority: Mexico: Ministry of Health

ClinicalTrials.gov processed this record on May 22, 2013