The Heidelberg Engineering BI US Evaluation Study

June 10, 2025 updated by: Heidelberg Engineering GmbH
Evaluation of defined parameters measured in pathological and non-pathological eyes with the Heidelberg BI

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10036
        • State University of New York College of Optometry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Anterior Segment Pathology
single measurement Anterior Segment Pathology
Device: BI Anterior Segment Mode
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
Device: BI Anterior Segment and IOL Biometry Mode
Eye measurement 3 times with and without dilation in IOL biometry and Anterior Segment mode

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day
Repeatabiltiy of specific parameters of the biometry images of the eye
Time Frame: 1 day
Repeatability of specific parameters stratified by different eye pathologies
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg Engineering GmbH

Investigators

  • Principal Investigator: Mitchell Dul, OD, State University of New York College of Optometry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2018

Primary Completion (Actual)

December 3, 2018

Study Completion (Actual)

December 3, 2018

Study Registration Dates

First Submitted

June 21, 2018

First Submitted That Met QC Criteria

July 3, 2018

First Posted (Actual)

July 6, 2018

Study Record Updates

Last Update Posted (Actual)

June 12, 2025

Last Update Submitted That Met QC Criteria

June 10, 2025

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-2018-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Eye Abnormalities

Clinical Trials on BI Anterior Segment Mode

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe