Freedom Meditech ClearPath DS-120 Clinical Study Protocol FM2-002-CTP

Freedom Meditech1 site in 1 country128 target enrollmentJune 2011

ConditionsOphthalmic, Healthy Eyes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ophthalmic, Healthy Eyes
Sponsor: Freedom Meditech
Enrollment: 128
Locations: 1
Primary Endpoint: Lens fluorescence
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2011

End Date

July 2011

Last Updated

14 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Freedom Meditech

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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).