Normal EyesNCT03578302
The Heidelberg Engineering BI US Evaluation Study
An observational study of Normal Eyes and Eye Abnormalities, run by Heidelberg Engineering GmbH at 1 site in United States.
Trial summary
Evaluation of defined parameters measured in pathological and non-pathological eyes with the Heidelberg BI Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Normal Eyes, Eye Abnormalities
- What is being tested?
- BI Anterior Segment Mode and BI Anterior Segment and IOL Biometry Mode
- Type of treatment
- Medical device
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2018to 3 Dec 2018
- 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: Subjects with: 1. Eyes with Normal Anterior Segment or 2. Eyes with Abnormal Anterior Segment, including Eyes with Cataract Eyes without a Crystalline Lens Eyes with Corneal Abnormality Eyes with Anterior Segment Pathology
Who may be able to join
- Age 18 years or older
- Able and willing to undergo the test procedures, sign informed consent, and follow instructions
- At least one of the following:
- Eyes with Normal Anterior Segment
- Eyes with Cataract
- Eyes without a Crystalline Lens
- Eyes with Corneal Abnormality
- Eyes with Anterior Segment Pathology
Who cannot join
- Subjects unable to read or write
- Active infection or inflammation in one or both eyes
- Insufficient tear film or corneal reflex
- Physical inability to be properly positioned at the study devices or eye exam equipment
- Inability to fixate
- Rigid contact lens wear during past 2 weeks
- Soft lenses, in the study eye, if worn, should be removed at least one hour prior to the measurements *Note: Eyes with risk for acute angle closure glaucoma are excluded from the dilated portion of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
State University of New York College of Optometry
New York, New York, 10036
About this study
Evaluation of defined parameters measured in pathological and non-pathological eyes with the Heidelberg BI
Read the detailed description
The primary objectives of this study are to assess the feasibility to acquire acceptable images and to assess repeatability
- Conditions
- Normal Eyes, Eye Abnormalities
- Being tested
- BI Anterior Segment Mode, BI Anterior Segment and IOL Biometry Mode
- Medical subject headings
- Eye Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI Anterior Segment ModeDevice
Single eye measurement in Anterior Segment Mode
BI Anterior Segment and IOL Biometry ModeDevice
Eye measurement 3 times with and without dilation in IOL biometry and Anterior Segment mode
| Study group | Role | What they receive |
|---|---|---|
| Anterior Segment Pathology | single measurement Anterior Segment Pathology Receives: Device: BI Anterior Segment Mode | |
| All except Anterior Segment Pathology | 3 repeat measurements with and without dilation for all eyes except Anterior Segment Pathology Receives: Device: BI Anterior Segment and IOL Biometry Mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of successfully scanned biometry images of the eye
Percentage of successfully scanned biometry images of the eyes per scan mode. Success is defined as agreement of the subjective assessment of the operator and the auto assessment of the device.
Measured: 1 day
Repeatabiltiy of specific parameters of the biometry images of the eye
Repeatability of specific parameters stratified by different eye pathologies
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start22 May 2018
- Primary completion3 Dec 2018
- Study completion3 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal EyesStudies 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 crossover
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg Engineering GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mitchell Dul, OD, Principal investigator, State University of New York College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578302
- Sponsor's protocol ID
- B-2018-1
- Status last verified
- Jan 2019
- First submitted
- 21 Jun 2018
- Last updated
- 12 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Heidelberg Engineering BI US Evaluation Study
- ClinicalTrials.gov ID
- NCT03578302
- Acronym / sponsor ID
- B-2018-1
- Conditions
- Normal Eyes, Eye Abnormalities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Heidelberg Engineering GmbHIndustry (pharma, biotech, devices)
- Study start
- 22 May 2018 (actual)
- Primary completion
- 3 Dec 2018 (actual)
- Study completion
- 3 Dec 2018 (actual)
- First posted
- 6 Jul 2018 (actual)
- 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.
Evaluation of defined parameters measured in pathological and non-pathological eyes with the Heidelberg BI
Detailed description
The primary objectives of this study are to assess the feasibility to acquire acceptable images and to assess repeatability
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior Segment Pathology | – | Device: BI Anterior Segment Modesingle measurement Anterior Segment Pathology |
| All except Anterior Segment Pathology | – | Device: BI Anterior Segment and IOL Biometry Mode3 repeat measurements with and without dilation for all eyes except Anterior Segment Pathology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with: 1. Eyes with Normal Anterior Segment or 2. Eyes with Abnormal Anterior Segment, including Eyes with Cataract Eyes without a Crystalline Lens Eyes with Corneal Abnormality Eyes with Anterior Segment Pathology
Key inclusion criteria (8 listed)
- Age 18 years or older
- Able and willing to undergo the test procedures, sign informed consent, and follow instructions
- Eyes with Normal Anterior Segment
- Eyes with Cataract
- Eyes without a Crystalline Lens
Key exclusion criteria (7 listed)
- Subjects unable to read or write
- Active infection or inflammation in one or both eyes
- Insufficient tear film or corneal reflex
- Physical inability to be properly positioned at the study devices or eye exam equipment
- Inability to fixate
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 |
|---|---|---|
| BI Anterior Segment ModeSingle eye measurement in Anterior Segment Mode | Device | Anterior Segment Pathology |
| BI Anterior Segment and IOL Biometry ModeEye measurement 3 times with and without dilation in IOL biometry and Anterior Segment mode | Device | All except Anterior Segment Pathology |
Primary outcome
Percentage of successfully scanned biometry images of the eye
Time frame: 1 day
Percentage of successfully scanned biometry images of the eyes per scan mode. Success is defined as agreement of the subjective assessment of the operator and the auto assessment of the device.
Repeatabiltiy of specific parameters of the biometry images of the eye
Time frame: 1 day
Repeatability of specific parameters stratified by different eye pathologies
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 12 Jun 2025.
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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.
Mitchell Dul, OD principal investigator
State University of New York College of Optometry
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 Eyes and Eye Abnormalities, run by Heidelberg Engineering GmbH 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 8 inclusion and 7 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 12 Jun 2025. 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?
Percentage of successfully scanned biometry images of the eye (time frame: 1 day). The study lists 2 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 12 Jun 2025.