First-Sight Refractive Error Correction in the Developing World

The aim of this study is to test the efficacy of the First-Sight refractive kit designed to provide refractive correction of simple hyperopia, myopia and astigmatism with autorefraction.

Study Overview

• Status: Completed
• Conditions: Vision Loss

Detailed Description

In remote and underserved areas, a patient may have limited or no access to eye specialists or healthcare facilities that offer equipment to provide standard refraction and purchase corrective lenses. First Sight Refracting system (FSR) is designed specifically to be used in remote and underserved areas. FSR is not considered the standard of care in the US. FSR is a portable refraction and lens-frame dispensing system with low cost of production. As a kit, it contains +/- 6.00 diopters of corrective lenses, color coordinated flipper, - 1.25 diopter astigmatism lens, visual acuity chart, astigmatic eye chart, measuring tape to measure the distance of the subject to the eye charts, pupillary distance ruler to measure for the frame size of the glasses to be dispensed, and lint free gloves. The kit comes with two standard frames. The corrective lenses are designed to be placed in the frames that can be readily dispensed to the patient after the refraction is done. The refraction technique is simple and straightforward and any healthcare worker in remote and underserved areas can provide the test and dispense glasses at no cost.

This is the third phase of First Sight refractive study to be done in Haiti. Adult and children subjects will be recruited during their routine examinations and/or visual acuity screenings at the Justinien Hospital. The proposed study will compare the visual acuity measurements obtained from the First Sight refraction system (test procedure) with the visual acuity measurements obtained from the autorefraction (standard care). The international study will recruit 150 subjects which will test FSR's effectiveness as a refracting tool of choice to be used in remote and underserved areas. Data from this study will be compared with the US studies.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Haiti
  • Cap-Haïtien, Haiti
    • Justinien Hospital
• 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 50 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:

• Subjects must be 7 years of age and older
• Healthy subjects with no known ocular trauma, no surgery, ocular disease or pathology that would prevent obtainment of best correctable visual acuity to 20/30.

Exclusion Criteria:

• Refractive error greater than (+)/(-) 6.00 diopter, or astigmatism greater than 1.50 diopters.
• Known ocular (corneal, lenticular, vitreal, or retinal) pathology that may limit best correctable visual acuity.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Visual acuity; Comparison of best visual acuity and refraction using the First Sight Refractive System with autorefraction in subjects with refractive error.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the best visual acuity and refraction results using the First Sight Refraction System to standard auto-refraction in subjects with hyperopia.	A refractive error of +0.50 to +4.50 diopter spherical error and asitgmatism of 1.50 diopters will be assessed.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the best visual acuity and refraction results using the First Sight Refractive System to autorefraction in myopia.	A refractive error of -0.50 to -4.50 diopter spherical error and up to 1.50 astigmatism will be compared.	1 month

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Michael Feilmeier, MD, University of Nebraska Medical Center, Department of Ophthalmology and Visual Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2012
• Primary Completion (Actual): January 13, 2014
• Study Completion (Actual): January 13, 2014

Study Registration Dates

• First Submitted: May 11, 2012
• First Submitted That Met QC Criteria: May 14, 2012
• First Posted (Estimated): May 15, 2012

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Vision Nearsighted; Vision Farsighted
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: 0553-11-FB