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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 September 18, 2014
Ophthalmic, healthy eye, fluorescence, lens