The Heidelberg Engineering BI US Evaluation Study

Heidelberg Engineering GmbH39 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Normal Eyes Eye Abnormalities

Interventions

BI Anterior Segment ModeDEVICE

Single eye measurement in Anterior Segment Mode

BI Anterior Segment and IOL Biometry ModeDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

State University of New York College of Optometry

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 1 day

Repeatabiltiy of specific parameters of the biometry images of the eye

Repeatability of specific parameters stratified by different eye pathologies

Time frame: 1 day

Data from ClinicalTrials.gov

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