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ClearPath DS-120 Clinical Study Protocol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Freedom Meditech
ClinicalTrials.gov Identifier:
NCT01425346
First received: August 24, 2011
Last updated: August 26, 2011
Last verified: August 2011
History of Changes

August 24, 2011
August 26, 2011
June 2011
July 2011   (final data collection date for primary outcome measure)
Lens fluorescence [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01425346 on ClinicalTrials.gov Archive Site
 
 
 
 
 
ClearPath DS-120 Clinical Study Protocol
Freedom Meditech ClearPath DS-120 Clinical Study Protocol FM2-002-CTP

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
Observational Model: Case-Only
Time Perspective: Prospective
 
Probability Sample

Healthy, normal subject population with healthy eyes as determined by standard comprehensive ophthalmic examination.
Ophthalmic, Healthy Eyes
 
Normal Healthy
Normal, healthy males and females between the ages of 21 and 70 with healthy eyes as determined by a standard ophthalmic examination.
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
128
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
21 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01425346
FM2-002-CTP
No
Freedom Meditech
Freedom Meditech
 
Principal Investigator: Stephen W. Lum, O.D. San Diego Optometry Practice
Freedom Meditech
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP