Skip to main content
OpenTrials
Completed

NCT Number: NCT03578302

The Heidelberg Engineering BI US Evaluation Study

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Normal Eyes Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Abnormalities Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

State University of New York College of Optometry

New York, 10036, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

BI Anterior Segment Mode

Device

Single eye measurement in Anterior Segment Mode

BI Anterior Segment and IOL Biometry Mode

Device

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

Primary outcomes

  1. 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.

  2. Repeatabiltiy of specific parameters of the biometry images of the eye

    Time frame: 1 day

    Repeatability of specific parameters stratified by different eye pathologies

Sponsors and collaborators

Lead sponsor

Heidelberg Engineering GmbH

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 6, 2018
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.