Axial Length (AL)NCT00804869
A-mode vs PalmScan Ultrasonography: Biometric Measurements.
An observational study of Axial Length (AL) and Anterior Chamber Deep (ACD), run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Axial Length (AL), Anterior Chamber Deep (ACD), Lens Thickness (LT)
- What is being tested?
- PalmScan A2000 ultrasonography system (Micro Medical Devices, Calabasas, CA) and Standard A-mode ultrasound (Eye Cubed™, Ellex, Adelaide, Australia).
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- Oct 2008to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients who need axial length calculation.
Who may be able to join
- Patients with indication for a standard A-mode ultrasound
Who cannot join
- No superficial anormalities.
- Patients with external injuries.
- Intraocular silicon oil.
- Retinal detachment
- Significant ocular pathologies.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Asociación para Evitar la Ceguera en México
Mexico City, Mexico City, 04030
About this study
Official title: Standard A-mode Ultrasonography vs PalmScan Ultrasonography: Biometric Measurements.
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.
- Being tested
- PalmScan A2000 ultrasonography system (Micro Medical Devices, Calabasas, CA), Standard A-mode ultrasound (Eye Cubed™, Ellex, Adelaide, Australia).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalmScan A2000 ultrasonography system (Micro Medical Devices, Calabasas, CA)Device
PalmScan biometric measurements
Standard A-mode ultrasound (Eye Cubed™, Ellex, Adelaide, Australia).Device
A-mode biometric measurements group
| Study group | Role | What they receive |
|---|---|---|
| 1 | PalmScan biometric group Receives: Device: PalmScan A2000 ultrasonography system (Micro Medical Devices, Calabasas, CA) | |
| 2 | A-mode ultrasonography biometric group Receives: Device: Standard A-mode ultrasound (Eye Cubed™, Ellex, Adelaide, Australia). |
What is being measured
The primary outcome is the main question the study is designed to answer.
axial length (AL).
Measured: during examination
Anterior Chamber Deep (ACD)
Measured: during examination
Lens Thickness (LT)
Measured: during examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: Undefined
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axial Length (AL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociación para Evitar la Ceguera en México
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804869
- Sponsor's protocol ID
- APEC-037
- Status last verified
- May 2024
- First submitted
- 3 Dec 2008
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard A-mode Ultrasonography vs PalmScan Ultrasonography: Biometric Measurements.
- ClinicalTrials.gov ID
- NCT00804869
- Acronym / sponsor ID
- APEC-037
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Undefined
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Asociación para Evitar la Ceguera en MéxicoUniversity, hospital or other
- Study start
- Oct 2008 (actual)
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 9 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: PalmScan A2000 ultrasonography system (Micro Medical Devices, Calabasas, CA)PalmScan biometric group |
| 2 | – | Device: Standard A-mode ultrasound (Eye Cubed™, Ellex, Adelaide, Australia).A-mode ultrasonography biometric group |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who need axial length calculation.
Key inclusion criteria (1 listed)
- Patients with indication for a standard A-mode ultrasound
Key exclusion criteria (5 listed)
- No superficial anormalities.
- Patients with external injuries.
- Intraocular silicon oil.
- Retinal detachment
- Significant ocular pathologies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PalmScan A2000 ultrasonography system (Micro Medical Devices, Calabasas, CA)PalmScan biometric measurements | Device | 1 |
| Standard A-mode ultrasound (Eye Cubed™, Ellex, Adelaide, Australia).A-mode biometric measurements group | Device | 2 |
Primary outcome
axial length (AL).
Time frame: during examination
Anterior Chamber Deep (ACD)
Time frame: during examination
Lens Thickness (LT)
Time frame: during examination
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Axial Length (AL) and Anterior Chamber Deep (ACD), run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
axial length (AL). (time frame: during examination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.