ClearPath DS-120 Clinical Study Protocol

Completed

• Conditions: Ophthalmic, Healthy Eyes

• Registration Number: NCT01425346
• Lead Sponsor: Freedom Meditech

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2011-08
• Study First Submitted: 2011-08-24
• Study First Submitted QC: 2011-08-26
• Last Update Submitted: 2011-08-26
• Study First Posted: 2011-08-30
• Last Update Posted: 2011-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

San Diego Optometry Practice; 🇺🇸 San Diego, California, United States