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Completed

NCT Number: NCT01598818

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.

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Key information

Age range

7 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Justinien Hospital, Cap-Haïtien, Haiti

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. To compare the best visual acuity and refraction results using the First Sight Refraction System to standard auto-refraction in subjects with hyperopia.

    Time frame: 1 month

    A refractive error of +0.50 to +4.50 diopter spherical error and asitgmatism of 1.50 diopters will be assessed.

Secondary outcomes

  1. To compare the best visual acuity and refraction results using the First Sight Refractive System to autorefraction in myopia.

    Time frame: 1 month

    A refractive error of -0.50 to -4.50 diopter spherical error and up to 1.50 astigmatism will be compared.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 15, 2012
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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