Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
39 participants
OBSERVATIONAL
2018-05-22
2018-12-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CROSSOVER
PROSPECTIVE
Study Groups
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Anterior Segment Pathology
single measurement Anterior Segment Pathology
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
BI Anterior Segment and IOL Biometry Mode
Eye measurement 3 times with and without dilation in IOL biometry and Anterior Segment mode
Interventions
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BI Anterior Segment Mode
Single eye measurement in Anterior Segment Mode
BI Anterior Segment and IOL Biometry Mode
Eye measurement 3 times with and without dilation in IOL biometry and Anterior Segment mode
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
Yes
Sponsors
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Heidelberg Engineering GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Mitchell Dul, OD
Role: PRINCIPAL_INVESTIGATOR
State University of New York College of Optometry
Locations
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State University of New York College of Optometry
New York, New York, United States
Countries
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Other Identifiers
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B-2018-1
Identifier Type: -
Identifier Source: org_study_id
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