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First-Sight Refractive Error Correction in the Developing World

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Donna Neely, MBA, COMT, University of Nebraska Medical Center
ClinicalTrials.gov Identifier:
NCT01598818
First received: May 11, 2012
Last updated: July 3, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition
Vision Loss

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: First-Sight Refractive Error Correction in the Developing World

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    A refractive error of +0.50 to +4.50 diopter spherical error and asitgmatism of 1.50 diopters will be assessed.


Secondary Outcome Measures:
  • To compare the best visual acuity and refraction results using the First Sight Refractive System to autorefraction in myopia. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    A refractive error of -0.50 to -4.50 diopter spherical error and up to 1.50 astigmatism will be compared.


Enrollment: 150
Study Start Date: May 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Visual acuity
Comparison of best visual acuity and refraction using the First Sight Refractive System with autorefraction in subjects with refractive error.

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.

  Eligibility

Ages Eligible for Study:   7 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01598818

Locations
United States, Nebraska
University of Nebraska Medical Center, Department of Ophthalmology
Omaha, Nebraska, United States, 68198-5540
Haiti
Justinien Hospital
Cape Haitien, Haiti
Sponsors and Collaborators
Donna Neely, MBA, COMT
Investigators
Principal Investigator: Michael Feilmeier, MD University of Nebraska Medical Center, Department of Ophthalmology and Visual Sciences
  More Information

No publications provided

Responsible Party: Donna Neely, MBA, COMT, Clinical Research Manager, University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT01598818     History of Changes
Other Study ID Numbers: 553-11-FB
Study First Received: May 11, 2012
Last Updated: July 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
Vision Nearsighted
Vision Farsighted

Additional relevant MeSH terms:
Refractive Errors
Blindness
Eye Diseases
Vision Disorders
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013