NCT01598818

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2012

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

May 11, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2014

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

1.7 years

First QC Date

May 11, 2012

Last Update Submit

August 29, 2023

Conditions

Vision Loss

Keywords

Vision NearsightedVision Farsighted

Outcome Measures

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.

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

    1 month

Secondary Outcomes (1)

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

    1 month

Study Arms (1)

Visual acuity

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

Eligibility Criteria

Age7 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Population with refractive error between -4.50 to +4.50 diopter spherical error and astigmatism up to 1.50 diopters.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Nebraska Medical Center, Department of Ophthalmology

Omaha, Nebraska, 68198-5540, United States

Location

Justinien Hospital

Cap-Haïtien, Haiti

Location

MeSH Terms

Conditions

Vision Disorders

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Feilmeier, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2012

First Posted

May 15, 2012

Study Start

May 11, 2012

Primary Completion

January 13, 2014

Study Completion

January 13, 2014

Last Updated

September 1, 2023

Record last verified: 2023-08

Locations

US(1)HA(1)