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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief Summary: 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.

Detailed Summary:

Uncorrected refractive error is a frequent cause of visual impairment in the global population. In 2006, the World Health Organization released global estimates on visual impairment. According to their findings, there are approximately 314 million people in the world whose vision is impaired. Of this population 90% of those individuals live in developing countries and 153 million cases are believed to be due to uncorrected refractive error. The impact of uncorrected refractive error is great, including, but not limited to, loss of employment opportunities, inability to care for family, and inability to receive an education. The challenge is to determine the most effective and accessible method of detecting refractive error and dispensing spectacles for better vision.

In the clinical setting, refractive error is corrected by prescribing spectacles or contact lenses on a daily basis. Typically the patient will first undergo autorefraction, in which a computer-controlled machine is used to objectively calculate the refractive error present as a starting point for the subjective refraction test. This machine, however, is cumbersome and not easily transportable abroad. Typically the machine is held up to the patient's forehead and they are asked to look into the machine at a distant object. While they are looking at this object the machine calculates the refractive error. Next, the patient undergoes manifest refraction, a subjective refractive test that requires the use of trial lenses and patient responses to improve the results calculated by autorefraction, resulting in the best corrected visual acuity for that patient and a prescription for the patient to receive spectacles tailored to their need.

As a testimony to how prevalent uncorrected refractive error is in the developing world, refractive error in Nigerian adults and
Sponsor: University of Nebraska

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Nebraska

Dates:
Date Received: April 25, 2011
Date Started: April 2011
Date Completion:
Last Updated: January 9, 2012
Last Verified: January 2012