The Heidelberg Engineering BI US Evaluation Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03578302

Enrollment

Registered

2018-07-06

Start date

2018-05-22

Completion date

2018-12-03

Last updated

2025-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eye Abnormalities, Normal Eyes

Brief summary

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

Interventions

DEVICEBI Anterior Segment Mode

Single eye measurement in Anterior Segment Mode

DEVICEBI Anterior Segment and IOL Biometry Mode

Eye measurement 3 times with and without dilation in IOL biometry and Anterior Segment mode

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Age 18 years or older 2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions At least one of the following: 3. Eyes with Normal Anterior Segment 4. Eyes with Cataract 5. Eyes without a Crystalline Lens 6. Eyes with Corneal Abnormality 7. Eyes with Anterior Segment Pathology

Exclusion criteria

1. Subjects unable to read or write 2. Active infection or inflammation in one or both eyes 3. Insufficient tear film or corneal reflex 4. Physical inability to be properly positioned at the study devices or eye exam equipment 5. Inability to fixate 6. Rigid contact lens wear during past 2 weeks 7. 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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of successfully scanned biometry images of the eye	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	1 day	Repeatability of specific parameters stratified by different eye pathologies

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026