ClearPath DS-120 Clinical Study Protocol

Freedom Meditech

Status: Completed

Conditions: Ophthalmic, Healthy Eyes

Study type: Observational

Funder types: Industry

Identifiers

NCT01425346

FM2-002-CTP

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

128 participants in 1 patient group

Normal Healthy

Description:

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