Normal Non-fluencyNCT01729962
Comparative Study of the Optical Biometer for Measurements of the Eye
An observational study of Normal Non-fluency and Cataract, run by Nidek Co. LTD. at 1 site in United States.
Trial summary
The primary purpose of this comparative clinical study is to collect clinical data to demonstrate the equivalence of the investigational device to the predicate device for measurements of the eye. The secondary purpose is to evaluate any adverse events that occur during the clinical study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Normal Non-fluency, Cataract, Aphakic Eye
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to May 2013
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal eyes(phakic eyes without cataracts or corneal disease), eyes with cataracts, eyes without a natural lens (including aphakic and pseudophakic eyes), eyes with corneal disease (including eyes post keratorefractive surgery).
Who may be able to join
- Subjects who can follow the instructions by the Principal/Clinical Investigator or clinical staff at the clinical site, and can visit on scheduled examination dates.
- Subjects who sign an informed consent form to participate in the clinical trial.
- Subjects who agree to take the qualifying eye examination and a series of devices measurements.
- Subjects able to fixate on a target.
- Subjects must meet at lease one of the following criteria:
- Normal eyes: Subjects with a natural lens without a cataract, corneal abnormalities or prior keratorefractive surgery.
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- Eyes with Cataracts: Subjects with a pre-existing cataract without corneal abnormalities or prior keratorefractive surgery.
- Eyes without a Natural Lens: Subjects that are pseudophakic or aphakic without corneal abnormalities or prior keratorefractive surgery.
- Eyes with Corneal Abnormality: Subjects with a corneal abnormality and a natural lens without a cataract, or Subjects post keratorefractive surgery and a natural lens without a cataract.
Who cannot join
- Pregnancy.
- Any eye condition preventing use of any of the instruments used in the study.
- Any eye condition which might impair the validity of results from any of the instruments used in the study.
- Any medical condition, which, in the Investigator's judgment, interferes with the subject's ability to comply with the protocol, compromises subject safety, or interferes with the interpretation of the study results.
Trial locations and contacts
1 site in 1 country.
United States1 site
Physicians Protocol
Greensboro, North Carolina, 27410-2548
About this study
Official title: Comparative Study of the Optical Biometer for the Measurements of Axial Length, Anterior Chamber Depth, Keratometry, Corneal Cylinder Axis, Corneal Thickness, White-to-White Distance, and Pupil Diameter
The primary purpose of this comparative clinical study is to collect clinical data to demonstrate the equivalence of the investigational device to the predicate device for measurements of the eye. The secondary purpose is to evaluate any adverse events that occur during the clinical study.
Read the detailed description
This is a prospective clinical study to be conducted at a single clinical site located in the United States. This study will assess the agreement of an investigational device to the predicate device and an ultrasound reference device and the precision of the investigational device with a comparison to the precision of the predicate. Any adverse events associated with the investigational device can or the predicate device will be assessed.
- Medical subject headings
- Cataract, Aphakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Agreement Cohort | All subjects in the agreement portion of the study will have a single measurement performed with each device, the Nidek optical biometer, predicate device and ultrasound reference device. Each device will be operated by a different operator. | |
| Precision Cohort | All subjects in the precision portion of the study will each be paired with one Nidek optical biometer and with one predicate device for a total of three Nidek optical biometer/predicate device pairs. Each of the three device pairs will be designated one and only one operator. All subjects in the precision portion of the study will have their measurements repeated three times on each of three Nidek optical biometer and predicate device pairs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement and Precision Endpoints Analyses
The agreement of the Nidek optical biometer with the predicate device will be assessed for the following measures:
- Axial Length;
- Keratometry;
- Corneal Cylinder Axis;
- Anterior Chamber Depth;
- Central Corneal Thickness;
- White-to-White Distance; and
- Pupil Diameter.
In addition, the agreement of the Nidek optical biometer with the ultrasound reference device will be assessed for axial length and anterior chamber depth.
The precision of Nidek optical biometer and the predicate device will be assessed for the following measures:
- Axial Length;
- Keratometry;
- Corneal Cylinder Axis;
- Anterior Chamber Depth;
- Central Corneal Thickness;
- White-to-White Distance; and
- Pupil Diameter.
Measured: Subjects will be followed for the duration of the procedure, up to one day.
Secondary outcomes (1)
Evaluation of Adverse Events Found During the Study
The safety endpoint is to evaluate any adverse events associated with the Nidek optical biometer or the predicate or reference devices.
Measured: Subjects will be followed for the duration of the procedure, up to one day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionApr 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Non-fluencyStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nidek Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karl G Stonecipher, M.D., Principal investigator, Physicians Protocol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729962
- Sponsor's protocol ID
- AL-3
- Status last verified
- Jun 2013
- First submitted
- 7 Nov 2012
- Last updated
- 28 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Optical Biometer for the Measurements of Axial Length, Anterior Chamber Depth, Keratometry, Corneal Cylinder Axis, Corneal Thickness, White-to-White Distance, and Pupil Diameter
- ClinicalTrials.gov ID
- NCT01729962
- Acronym / sponsor ID
- AL-3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Nidek Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 21 Nov 2012 (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.
The primary purpose of this comparative clinical study is to collect clinical data to demonstrate the equivalence of the investigational device to the predicate device for measurements of the eye. The secondary purpose is to evaluate any adverse events that occur during the clinical study.
Detailed description
This is a prospective clinical study to be conducted at a single clinical site located in the United States. This study will assess the agreement of an investigational device to the predicate device and an ultrasound reference device and the precision of the investigational device with a comparison to the precision of the predicate. Any adverse events associated with the investigational device can or the predicate device will be assessed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Agreement Cohort | – | –All subjects in the agreement portion of the study will have a single measurement performed with each device, the Nidek optical biometer, predicate device and ultrasound reference device. Each device will be operated by a different operator. |
| Precision Cohort | – | –All subjects in the precision portion of the study will each be paired with one Nidek optical biometer and with one predicate device for a total of three Nidek optical biometer/predicate device pairs. Each of the three device pairs will be designated one and only one operator. All subjects in the precision portion of the study will have their measurements repeated three times on each of three Nidek optical biometer and predicate device pairs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal eyes(phakic eyes without cataracts or corneal disease), eyes with cataracts, eyes without a natural lens (including aphakic and pseudophakic eyes), eyes with corneal disease (including eyes post keratorefractive surgery).
Key inclusion criteria (9 listed)
- Subjects who can follow the instructions by the Principal/Clinical Investigator or clinical staff at the clinical site, and can visit on scheduled examination dates.
- Subjects who sign an informed consent form to participate in the clinical trial.
- Subjects who agree to take the qualifying eye examination and a series of devices measurements.
- Subjects able to fixate on a target.
- Subjects must meet at lease one of the following criteria:
Key exclusion criteria (4 listed)
- Pregnancy.
- Any eye condition preventing use of any of the instruments used in the study.
- Any eye condition which might impair the validity of results from any of the instruments used in the study.
- Any medical condition, which, in the Investigator's judgment, interferes with the subject's ability to comply with the protocol, compromises subject safety, or interferes with the interpretation of the study results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement and Precision Endpoints Analyses
Time frame: Subjects will be followed for the duration of the procedure, up to one day.
The agreement of the Nidek optical biometer with the predicate device will be assessed for the following measures: * Axial Length; * Keratometry; * Corneal Cylinder Axis; * Anterior Chamber Depth; * Central Corneal Thickness; * White-to-White Distance; and * Pupil Diameter. In addition, the agreement of the Nidek optical biometer with the ultrasound reference device will be assessed for axial length and anterior chamber depth. The precision of Nidek optical biometer and the predicate device will be assessed for the following measures: * Axial Length; * Keratometry; * Corneal Cylinder Axis; * Anterior Chamber Depth; * Central Corneal Thickness; * White-to-White Distance; and * Pupil Diameter.
1 secondary outcome
Evaluation of Adverse Events Found During the Study
Time frame: Subjects will be followed for the duration of the procedure, up to one day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2013.
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.
Karl G Stonecipher, M.D. principal investigator
Physicians Protocol
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 Normal Non-fluency and Cataract, run by Nidek Co. LTD. at 1 site in United States.
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 9 inclusion and 4 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: finished, as of the sponsor's last update on 28 Jun 2013. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Agreement and Precision Endpoints Analyses (time frame: Subjects will be followed for the duration of the procedure, up to one day.). 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 28 Jun 2013.