ClearPath DS-120 Clinical Study Protocol

Sponsor

Freedom Meditech (Industry)

Overall Status

Completed

CT.gov ID

NCT01425346

Collaborator

(none)

128

Enrollment

Location

Duration (Days)

129.9

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Ophthalmic, Healthy Eyes

Study Design

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 :

Jun 1, 2011

Actual Primary Completion Date :

Jul 1, 2011

Actual Study Completion Date :

Jul 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Lens fluorescence [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Freedom Meditech

ClinicalTrials.gov Identifier:

NCT01425346

Other Study ID Numbers:

FM2-002-CTP

First Posted:

Aug 30, 2011

Last Update Posted:

Aug 30, 2011

Last Verified:

Aug 1, 2011

Keywords provided by Freedom Meditech

Ophthalmic, healthy eye, fluorescence, lens

Study Results

No Results Posted as of Aug 30, 2011