ClearPath DS-120 Clinical Study Protocol

NCT ID: NCT01425346

Last Updated: 2011-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

128 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ophthalmic, Healthy Eyes

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal Healthy

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Freedom Meditech

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen W. Lum, O.D.

Role: PRINCIPAL_INVESTIGATOR

San Diego Optometry Practice

Locations

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San Diego Optometry Practice

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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FM2-002-CTP

Identifier Type: -

Identifier Source: org_study_id

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