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.

Study Overview

• Status: Completed
• Conditions: Ophthalmic, Healthy Eyes

• Study Type: Observational
• Enrollment (Actual): 128

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92122
      • San Diego Optometry Practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Healthy, normal subject population with healthy eyes as determined by standard comprehensive ophthalmic examination.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens fluorescence	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).	Day 1

Collaborators and Investigators

• Sponsor: Freedom Meditech
• Investigators: Principal Investigator: Stephen W. Lum, O.D., San Diego Optometry Practice

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (ACTUAL): July 1, 2011
• Study Completion (ACTUAL): July 1, 2011

Study Registration Dates

• First Submitted: August 24, 2011
• First Submitted That Met QC Criteria: August 26, 2011
• First Posted (ESTIMATE): August 30, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): August 30, 2011
• Last Update Submitted That Met QC Criteria: August 26, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Ophthalmic, healthy eye, fluorescence, lens
• Other Study ID Numbers: FM2-002-CTP