First-Sight Refractive Error Correction in the Developing World

NCT ID: NCT01598818

Last Updated: 2023-09-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-05-11
• Study Completion Date: 2014-01-13

Brief 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.

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.

Conditions

Vision Loss

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Visual acuity

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

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Feilmeier, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska Medical Center, Department of Ophthalmology and Visual Sciences

Locations

University of Nebraska Medical Center, Department of Ophthalmology

Omaha, Nebraska, United States

Justinien Hospital

Cap-Haïtien, , Haiti

Countries

United States; Haiti

Other Identifiers

0553-11-FB

Identifier Type: -

Identifier Source: org_study_id