First-Sight Refractive Error Correction: Direct Comparison to Autorefraction Results in Children 7 to 18 Years of Age

Proof of Concept Study for First-Sight Refractive Error Correction: Direct Comparison to Autorefraction Results in Children 7 to 18 Years of Age

Proof of concept study to compare the best corrected visual acuity obtained via First-Sight lenses with the autorefraction in children.

Study Overview

• Status: Terminated
• Conditions: Refractive Error

Detailed Description

Uncorrected refractive error is a frequent cause of visual impairment in children most prevalent in rural or underserved areas 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. Children, ages five to 15 years, suffer from refractive errors (mostly myopia, hyperopia, and astigmatism) that can be improved to normal vision. It is estimated that by 2020, approximately one third of the world's population (2.5 billion) will be affected by myopia alone14. The prevalence of refractive error in school-aged children is significant especially the impact on a child's life in terms of education and development.

Studies in Western populations have collectively shown that myopia occurs <5% in children 8 years and younger. Sampling studies in other countries worldwide have shown that there is higher prevalence of myopia among Southeast Asia children and less among Australian children.1-11 Refractive error study in Eastern Nepal found 2.9% of children had vision of 20/40 or worse of which 56% of the 200 eyes tested was caused by refractive error due to myopia, hyperopia and astigmatism.12

The challenge is to determine the most effective and accessible method of detecting refractive error and dispensing spectacles for better vision. Children who have access to clinical setting typically receive prescriptive spectacles to correct refractive errors. However, in underserved areas where standard eye care may be absent, children are unable to receive the benefits of normal or near normal vision. 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 objectively calculates 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.

First-Sight is a simplified way to correct refractive error. It is easily portable, making it accessible to remote areas of the world. Unlike the study cited above, First-Sight can be taken to remote areas where clinics are not available and patients are not able to afford to pay for the clinic visit. As it is a simplified technique, local health care workers may easily be able to learn how to use First-Sight and dispense spectacles to those in need. Lastly, sponsors of First-Sight will provide the refracting kit and dispense custom-made spectacles at no cost to health care workers and children respectively.

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198-5540
      • University of Nebraska Medical Center, Department of Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Population with refractive error between -4.50 to +4.50 diopter spherical error and astigmatism up to -1.50 diopters.

Description

Inclusion Criteria:

1. Subjects are between 7 to 18 years of age.
2. Healthy subjects
3. 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 their medical records.
4. Best corrected visual acuity (BCVA) of 20/20 with cycloplegic refraction.
5. No known ocular pathology from previous clinical exams that may limit best corrected visual acuity.

Exclusion Criteria:

1. Refractive error greater than -4.50 or +4.50 diopter, or astigmatism greater than -1.50 diopters.
2. Known ocular (corneal, lenticular, vitreal, or retinal) pathology that may limit BCVA.
3. Best corrected visual acuity with spectacles of 20/25 or worse.
4. Any previous surgical or laser procedures that may limit BCVA
5. Narrow angles of the eyes
6. Adults, 19 years or older

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare refracting methods	Will measure children's vision with First-Sight refracting kit and compare it to the two standard methods used in clinics.	1 hour

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Michael Feilmeier, MD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2011
• Primary Completion (Actual): February 12, 2014
• Study Completion (Actual): February 12, 2014

Study Registration Dates

• First Submitted: June 1, 2011
• First Submitted That Met QC Criteria: June 2, 2011
• First Posted (Estimated): June 3, 2011

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: 0201-11-FB