PseudoaphakiaPhase 4NCT01550939
Time Study for Biometry Measurements With the Lenstar and IntraOcularLens (IOL) Master 500
A Phase 4 study testing Ophthalmic Biometer in people with Pseudoaphakia, run by Haag Streit USA at 1 site in United States.
Trial summary
The objectives of this study are to determine the time needed to complete a full set of measurements (Total Ophthalmic Exam, Subject Data Entry and Acquisition of the Measurement) by each test device, the Lenstar 900 Version i4 and IOL Master 500. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pseudoaphakia
- What is being tested?
- Ophthalmic Biometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Mar 2012
- Phase
- Phase 4
- 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
Who may be able to join
- Subjects wbo meet all of the following criteria are eligible to participate in tbe study:
- Male or female l8 years of age or older on the date of Informed Consent.
- At least one eye of each subject must be a phakic eye.
- Subject must be able to fixate on a target.
- Able to understand and willing to sign tbe informed consent.
Who cannot join
- Subjects will be excluded from the study if the following applies:
- History of corneal surgery.
- Use of contact lenses during tbe ophthalmic exam or up to two hours prior to the exam.
- Any ophthalmic condition preventing use of either of the instruments used in the study.
- Any ophthalmic condition which might impair tbe validity of results from any of the instruments used in the study.
- Any medical condition, which, in tbe Investigator's judgment, interferes with the subjects ability to comply with tbe protocol, compromises subject safety, or interferes with tbe interpretation of the study results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Open-Label, Randomized Clinical Study Measuring Time Needed for Testing Between the Haag-Streit Lenstar 900 Version i4 and the Carl Zeiss IOL Master 500 Instruments
The objectives of this study are to determine the time needed to complete a full set of measurements (Total Ophthalmic Exam, Subject Data Entry and Acquisition of the Measurement) by each test device, the Lenstar 900 Version i4 and IOL Master 500.
Read the detailed description
This is an open-label study randomized by sequence. Each eligible subject who signs a consent form and fulfills all Inclusion/Exclusion criteria will undergo ophthalmic measurements by the two test products:
- Haag-Streit Lenstar Version i4
- Zeiss IOL Master 500
The order of measurements for the IOL Master 500 and the Haag-Streit Lenstar Version i4 will he randomized. The two possible sequences will be balanced (approximately 22 eyes each: AB,BA). One eye of each subject will be measured. Time needed to complete testing will be measured utilizing a stop-watch. Total time needed to complete all measurements of the study eye using each of the test products to capture a complete ophthalmic exam with the devices standard operating settings set to automatic measurement and analysis will be calculated by the following start and stop points:
First Timed Measurement: Measurement Acquisition Start: When the technician starts to acquire tbe first measurement Stop: When the technician has completed all measurements
Second Timed Measurement: Subject Data Entry Start: When the technician starts to enter the subject data. Stop: When the technician has completed subject data entry.
Third Timed Measurement: Complete Ophthalmic Exam with each test product Start: When tbe subject is seated at the instrument, just prior to the technician entering any subject data into the test product.
Stop: Upon completion of all measurements using one of the test products, just prior to printing results.
Three trained technicians will operate tbe same study devices (Haag-Streit Lenstar Version i4 and IOL Master 500). Approximately equal number of subjects will be assigned to each technician.
- Conditions
- Pseudoaphakia
- Being tested
- Ophthalmic Biometer
- Keywords
- Biometry of the Eye, Intraocular Lens Implantation, IOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophthalmic BiometerDevice
Also called Haag-Streit Lenstar, Zeiss IOL Master 500
One complete biometry examination
| Study group | Role | What they receive |
|---|---|---|
| Time Comparison between the Lenstar and IOLMaster | No intervention | Not described Receives: Device: Ophthalmic Biometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete a full examination
Time to complete a full ophthalmic exam(as measured from the time of subject placement just prior to the technician completing data entry at the test product, to the beginning of data printing) for each, the IOL Master 500 and the Haag-Streit Lenstar Version i4.
Measured: At Study Visit (study consists of 1 visit only)
Secondary outcomes (3)
Data Entry Time Measurement
Additional Time Measurements - Data Entry from the IOL Master 500 and the Haag-Streit Lenstar Version i4.
Measured: At Study Visit (study consists of 1 visit only)
Measurement Acquisition Time Measurement
Additional Timed Measurements - Measurement Acquisition from the IOL Master 500 and the Haag-Streit Lenstar Version i4.
Measured: At Study Visit (study consists of 1 visit only)
Adverse Events
Any adverse events associated with the test products
Measured: Duration of study from signing informed consent to Study Visit (study consists of 1 visit only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PseudoaphakiaStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haag Streit USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael E. Snyder, MD, Principal investigator, Cincinnati Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550939
- Sponsor's protocol ID
- HS1 Time Study 2
- Status last verified
- Jul 2012
- First submitted
- 5 Mar 2012
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label, Randomized Clinical Study Measuring Time Needed for Testing Between the Haag-Streit Lenstar 900 Version i4 and the Carl Zeiss IOL Master 500 Instruments
- ClinicalTrials.gov ID
- NCT01550939
- Acronym / sponsor ID
- HS1 Time Study 2
- Conditions
- Pseudoaphakia
- Keywords
- Biometry of the Eye, Intraocular Lens Implantation, IOL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Haag Streit USAIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 12 Mar 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 objectives of this study are to determine the time needed to complete a full set of measurements (Total Ophthalmic Exam, Subject Data Entry and Acquisition of the Measurement) by each test device, the Lenstar 900 Version i4 and IOL Master 500.
Detailed description
This is an open-label study randomized by sequence. Each eligible subject who signs a consent form and fulfills all Inclusion/Exclusion criteria will undergo ophthalmic measurements by the two test products:
- Haag-Streit Lenstar Version i4
- Zeiss IOL Master 500
The order of measurements for the IOL Master 500 and the Haag-Streit Lenstar Version i4 will he randomized. The two possible sequences will be balanced (approximately 22 eyes each: AB,BA). One eye of each subject will be measured. Time needed to complete testing will be measured utilizing a stop-watch. Total time needed to complete all measurements of the study eye using each of the test products to capture a complete ophthalmic exam with the devices standard operating settings set to automatic measurement and analysis will be calculated by the following start and stop points:
First Timed Measurement: Measurement Acquisition Start: When the technician starts to acquire tbe first measurement Stop: When the technician has completed all measurements
Second Timed Measurement: Subject Data Entry Start: When the technician starts to enter the subject data. Stop: When the technician has completed subject data entry.
Third Timed Measurement: Complete Ophthalmic Exam with each test product Start: When tbe subject is seated at the instrument, just prior to the technician entering any subject data into the test product.
Stop: Upon completion of all measurements using one of the test products, just prior to printing results.
Three trained technicians will operate tbe same study devices (Haag-Streit Lenstar Version i4 and IOL Master 500). Approximately equal number of subjects will be assigned to each technician.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Time Comparison between the Lenstar and IOLMaster | No intervention | Device: Ophthalmic Biometer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female l8 years of age or older on the date of Informed Consent.
- At least one eye of each subject must be a phakic eye.
- Subject must be able to fixate on a target.
- Able to understand and willing to sign tbe informed consent.
Key exclusion criteria (6 listed)
- History of corneal surgery.
- Use of contact lenses during tbe ophthalmic exam or up to two hours prior to the exam.
- Any ophthalmic condition preventing use of either of the instruments used in the study.
- Any ophthalmic condition which might impair tbe validity of results from any of the instruments used in the study.
- Any medical condition, which, in tbe Investigator's judgment, interferes with the subjects ability to comply with tbe protocol, compromises subject safety, or interferes with tbe 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ophthalmic BiometerAlso: Haag-Streit Lenstar, Zeiss IOL Master 500One complete biometry examination | Device | Time Comparison between the Lenstar and IOLMaster |
Primary outcome
Time to complete a full examination
Time frame: At Study Visit (study consists of 1 visit only)
Time to complete a full ophthalmic exam(as measured from the time of subject placement just prior to the technician completing data entry at the test product, to the beginning of data printing) for each, the IOL Master 500 and the Haag-Streit Lenstar Version i4.
3 secondary outcomes
Data Entry Time Measurement
Time frame: At Study Visit (study consists of 1 visit only)
Measurement Acquisition Time Measurement
Time frame: At Study Visit (study consists of 1 visit only)
Adverse Events
Time frame: Duration of study from signing informed consent to Study Visit (study consists of 1 visit only)
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 1 Aug 2012.
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.
Michael E. Snyder, MD principal investigator
Cincinnati Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ophthalmic Biometer in people with Pseudoaphakia, run by Haag Streit USA 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 5 inclusion and 6 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 1 Aug 2012. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to complete a full examination (time frame: At Study Visit (study consists of 1 visit only)). 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 1 Aug 2012.