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ClearPath DS-120 Clinical Study Protocol

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ClinicalTrials.gov Identifier: NCT01425346
Recruitment Status : Completed
First Posted : August 30, 2011
Last Update Posted : August 30, 2011
Sponsor:
Information provided by (Responsible Party):
Freedom Meditech

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 lens fluorescence can be used by clinicians as an indication of degenerative changes occurring in the lens of the eye.

Condition or disease
Ophthalmic, Healthy Eyes

Study Type : Observational
Actual Enrollment : 128 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Freedom Meditech ClearPath DS-120 Clinical Study Protocol FM2-002-CTP
Study Start Date : June 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Group/Cohort
Normal Healthy
Normal, healthy males and females between the ages of 21 and 70 with healthy eyes as determined by a standard ophthalmic examination.



Primary Outcome Measures :
  1. Lens fluorescence [ Time Frame: Day 1 ]
    evaluate the ability of the ClearPath DS-120 instrument to measure the fluorescence and scattering responses of the human crystalline lens in a normal subject population with healthy eyes (as determined by standard comprehensive ophthalmic examination).



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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy, normal subject population with healthy eyes as determined by standard comprehensive ophthalmic examination.
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01425346


Locations
United States, California
San Diego Optometry Practice
San Diego, California, United States, 92122
Sponsors and Collaborators
Freedom Meditech
Investigators
Principal Investigator: Stephen W. Lum, O.D. San Diego Optometry Practice

Responsible Party: Freedom Meditech
ClinicalTrials.gov Identifier: NCT01425346     History of Changes
Other Study ID Numbers: FM2-002-CTP
First Posted: August 30, 2011    Key Record Dates
Last Update Posted: August 30, 2011
Last Verified: August 2011

Keywords provided by Freedom Meditech:
Ophthalmic, healthy eye, fluorescence, lens