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
128 participants
OBSERVATIONAL
2011-06-30
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Normal Healthy
Normal, healthy males and females between the ages of 21 and 70 with healthy eyes as determined by a standard ophthalmic examination.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Subject must be able to read or understand and give informed consent.
* Pass the medical health history and comprehensive ophthalmic examination (which is determined by the investigator if the test subject has a normal ophthalmic examination and is in overall good health). Ophthalmic examination includes a clinical evaluation of the subject's eyes and a complete manifest refraction producing a best aided visual acuity of \<20/40.
Exclusion Criteria
* Subject has been clinically diagnosed with cataracts in the study eye.
* Subject has had a fluorescence angiogram within the last six months.
* Subject has undergone a treatment using photodynamic drugs within the last year.
* Subject has Type I or II diabetes or is not deemed healthy from Demographic and Health Questionnaire or the comprehensive eye exam.
* Subject was fit with contact lens within the last 30 days.
* Subject has ocular surface (dry eye) disease.
* Subject is unable to cooperate with or understand clinical instructions.
* Subject is unable to complete test sequence
21 Years
70 Years
ALL
Yes
Sponsors
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Freedom Meditech
INDUSTRY
Responsible Party
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Principal Investigators
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Stephen W. Lum, O.D.
Role: PRINCIPAL_INVESTIGATOR
San Diego Optometry Practice
Locations
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San Diego Optometry Practice
San Diego, California, United States
Countries
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Other Identifiers
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FM2-002-CTP
Identifier Type: -
Identifier Source: org_study_id
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