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First-Sight Refractive Error Correction in the Developing World

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ClinicalTrials.gov Identifier: NCT01598818
Recruitment Status : Completed
First Posted : May 15, 2012
Last Update Posted : July 4, 2012
Sponsor:
Information provided by (Responsible Party):
Donna Neely, MBA, COMT, University of Nebraska

Tracking Information
First Submitted Date May 11, 2012
First Posted Date May 15, 2012
Last Update Posted Date July 4, 2012
Study Start Date May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 14, 2012)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 14, 2012)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title First-Sight Refractive Error Correction in the Developing World
Official Title First-Sight Refractive Error Correction in the Developing World
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.

Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Vision Loss
Intervention Not Provided
Study Groups/Cohorts Visual acuity
Comparison of best visual acuity and refraction using the First Sight Refractive System with autorefraction in subjects with refractive error.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 14, 2012)
150
Original Estimated Enrollment Same as current
Actual Study Completion Date May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 7 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Haiti,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01598818
Other Study ID Numbers 553-11-FB
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Donna Neely, MBA, COMT, University of Nebraska
Study Sponsor Donna Neely, MBA, COMT
Collaborators Not Provided
Investigators
Principal Investigator: Michael Feilmeier, MD University of Nebraska Medical Center, Department of Ophthalmology and Visual Sciences
PRS Account University of Nebraska
Verification Date May 2012