First-Sight Refractive Error Correction in the Developing World

Vision Loss Clinical Trial

Official title:

First-Sight Refractive Error Correction in the Developing World

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01598818
• Other study ID #: 0553-11-FB
• Status: Completed
• Start date: May 11, 2012
• Est. completion date: January 13, 2014

Study information

• Verified date: August 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 13, 2014
• Est. primary completion date: January 13, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Refractive Errors
• Vision Loss

Locations

Country	Name	City	State
Haiti	Justinien Hospital	Cap-Haïtien
United States	University of Nebraska Medical Center, Department of Ophthalmology	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Countries where clinical trial is conducted

United States,  Haiti, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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