The Heidelberg Engineering BI US Evaluation Study

NCT ID: NCT03578302

Last Updated: 2025-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-22

Study Completion Date

2018-12-03

Brief Summary

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Evaluation of defined parameters measured in pathological and non-pathological eyes with the Heidelberg BI

Detailed Description

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The primary objectives of this study are to assess the feasibility to acquire acceptable images and to assess repeatability

Conditions

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Normal Eyes Eye Abnormalities

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Anterior Segment Pathology

single measurement Anterior Segment Pathology

BI Anterior Segment Mode

Intervention Type DEVICE

Single eye measurement in Anterior Segment Mode

All except Anterior Segment Pathology

3 repeat measurements with and without dilation for all eyes except Anterior Segment Pathology

BI Anterior Segment and IOL Biometry Mode

Intervention Type DEVICE

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

Interventions

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BI Anterior Segment Mode

Single eye measurement in Anterior Segment Mode

Intervention Type DEVICE

BI Anterior Segment and IOL Biometry Mode

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Heidelberg Engineering GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mitchell Dul, OD

Role: PRINCIPAL_INVESTIGATOR

State University of New York College of Optometry

Locations

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State University of New York College of Optometry

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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B-2018-1

Identifier Type: -

Identifier Source: org_study_id

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