ClearPath DS-120 Clinical Study Protocol
This study has been completed.
Information provided by (Responsible Party):
First received: August 24, 2011
Last updated: August 26, 2011
Last verified: August 2011
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 lens fluorescence can be used by clinicians as an indication of degenerative changes occurring in the lens of the eye.
||Observational Model: Case-Only
Time Perspective: Prospective
||Freedom Meditech ClearPath DS-120 Clinical Study Protocol FM2-002-CTP
Primary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2011 (Final data collection date for primary outcome measure)
Normal, healthy males and females between the ages of 21 and 70 with healthy eyes as determined by a standard ophthalmic examination.
|Ages Eligible for Study:
||21 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Healthy, normal subject population with healthy eyes as determined by standard comprehensive ophthalmic examination.
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01425346
|San Diego Optometry Practice
|San Diego, California, United States, 92122 |
||Stephen W. Lum, O.D.
||San Diego Optometry Practice
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 24, 2011
||August 26, 2011
||United States: Institutional Review Board
Keywords provided by Freedom Meditech:
ClinicalTrials.gov processed this record on March 10, 2014
Ophthalmic, healthy eye, fluorescence, lens