The Heidelberg Engineering BI US Evaluation Study

NCT03578302 | Completed FDA Device

• 1 other identifier: B-2018-1
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Normal Eyes; Eye Abnormalities

Outcome Measures

Primary Outcomes (2)

• 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.

  1 day

• Repeatabiltiy of specific parameters of the biometry images of the eye

  Repeatability of specific parameters stratified by different eye pathologies

  1 day

Study Arms (2)

Anterior Segment Pathology

single measurement Anterior Segment Pathology

Device: BI 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

Interventions

BI Anterior Segment Mode DEVICE

Single eye measurement in Anterior Segment Mode

Anterior Segment Pathology

BI Anterior Segment and IOL Biometry Mode DEVICE

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

All except Anterior Segment Pathology

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg Engineering GmbH: lead

Study Sites (1)

State University of New York College of Optometry

New York, New York, 10036, United States

Location

MeSH Terms

Conditions

Eye Abnormalities

Condition Hierarchy (Ancestors)

Eye Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Mitchell Dul, OD

  State University of New York College of Optometry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: July 6, 2018
• Study Start: May 22, 2018
• Primary Completion: December 3, 2018
• Study Completion: December 3, 2018
• Last Updated: June 12, 2025

Record last verified: 2019-01

Locations

US (1)