Status:
COMPLETED
ClearPath DS-120 Clinical Study Protocol
Lead Sponsor:
Freedom Meditech
Conditions:
Ophthalmic, Healthy Eyes
Eligibility:
All Genders
21-70 years
Brief Summary
The goal of this study is to measure lens fluorescence in normal subjects at various chronological ages that could serves as a guide to clinicians in determining changes in eye health. A measure of le...
Eligibility Criteria
Inclusion
- Persons between the ages of twenty-one (21) and seventy (70). Best efforts shall be made to include as many patients as possible between the ages of thirty-five (35) and sixty (60).
- 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
- Subject has had the crystalline lens removed from the study eye or has had the crystalline lens removed and replaced with an intraocular lens (IOL) implant in the left eye.
- 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
Key Trial Info
Start Date :
June 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT01425346
Start Date
June 1 2011
End Date
July 1 2011
Last Update
August 30 2011
Active Locations (1)
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1
San Diego Optometry Practice
San Diego, California, United States, 92122