The Heidelberg Engineering BI US Evaluation Study

Heidelberg Engineering

Status: Completed

Conditions: Normal Eyes; Eye Abnormalities

Treatments: Device: BI Anterior Segment Mode; Device: BI Anterior Segment and IOL Biometry Mode

Study type: Observational

Funder types: Industry

Identifiers

NCT03578302

B-2018-1

Details and patient eligibility

About

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

Full description

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

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

39 participants in 2 patient groups

Anterior Segment Pathology

Description:

single measurement Anterior Segment Pathology

Treatment:

Device: BI Anterior Segment Mode

All except Anterior Segment Pathology

Description:

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

Treatment:

Device: BI Anterior Segment and IOL Biometry Mode