An observational study in Vision Loss, sponsored by University of Nebraska. Completed at 2 sites in 2 countries. Open to participants aged 7 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-01.
Sponsored by University of Nebraska · Observational
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.
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.
360 studies on the registry are indexed under Vision Disorders; 84 are open to participants now.
This study's enrollment of 150 is above the median of 126 across 97 observational studies indexed under Vision Disorders.
Browse Vision Disorders studies →University of Nebraska is the lead sponsor of 496 studies on the registry; 67 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 53 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Population with refractive error between -4.50 to +4.50 diopter spherical error and astigmatism up to 1.50 diopters.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Comparison of best visual acuity and refraction using the First Sight Refractive System with autorefraction in subjects with refractive error.
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.
Time frame: 1 month
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.
Time frame: 1 month
Ran from May 2012 to primary completion in Jan 2014, 20 months.
Of 51 non-industry observational studies under Vision Disorders, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 42. This study's 20 months is below that.
Counting every sponsor, half of 58 studies reached it within 23 months; a quarter within 12 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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