Proof of Concept Study for First-Sight Refractive Error Correction: Direct Comparison to Manifest Refraction and Autorefraction Results

Completed

Conditions studied: Refractive Error

In brief

Proof of concept study is to compare the best corrected visual acuity obtained via First-Sight lenses with the clinical "gold standard" of manifest refraction and autorefraction.

Key facts

Study ID

NCT01342393

Run by

University of Nebraska

People needed

41

Starts

2011-04-01

Expected to finish

2011-08-01

Last updated by the study team

2012-01-11

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects must be 19 years of age and older.
• A refractive error of -4.50 to +4.50 diopter spherical error and astigmatism up to -1.50 diopters on manifest refraction and autorefraction as documented in the patient's medical records.
• Best corrected visual acuity (BCVA) of 20/20 with manifest refraction.
• No known ocular pathology from previous clinical exams that may limit best corrected visual acuity.

You may not qualify if…

• Refractive error greater than -4.50 or +4.50 diopter, or astigmatism greater than -1.50 diopters.
• Known ocular (corneal, lenticular, vitreal, or retinal) pathology that may limit BCVA.
• Best corrected visual acuity with spectacles of 20/25 or worse.
• Any previous surgical or laser procedures that may limit BCVA
• 18 years of age and younger

Where it is running

• University of Nebraska Medical Center, Department of Ophthalmology — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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