NCT01365884

Brief Summary

Proof of concept study to compare the best corrected visual acuity obtained via First-Sight lenses with the autorefraction in children.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

June 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

August 5, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2014

Completed
Last Updated

August 28, 2023

Status Verified

August 1, 2023

Enrollment Period

2.5 years

First QC Date

June 1, 2011

Last Update Submit

August 24, 2023

Conditions

Refractive Error

Outcome Measures

Primary Outcomes (1)

  • Compare refracting methods

    Will measure children's vision with First-Sight refracting kit and compare it to the two standard methods used in clinics.

    1 hour

Eligibility Criteria

Age7 Years - 18 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 are between 7 to 18 years of age.
  • Healthy subjects
  • A refractive error of -4.50 to +4.50 diopter spherical error and astigmatism up to -1.50 diopters on manifest refraction and autorefraction as documented in their medical records.
  • Best corrected visual acuity (BCVA) of 20/20 with cycloplegic refraction.
  • No known ocular pathology from previous clinical exams that may limit best corrected visual acuity.

You may not qualify if:

  • Refractive error greater than -4.50 or +4.50 diopter, or astigmatism greater than -1.50 diopters.
  • Known ocular (corneal, lenticular, vitreal, or retinal) pathology that may limit BCVA.
  • Best corrected visual acuity with spectacles of 20/25 or worse.
  • Any previous surgical or laser procedures that may limit BCVA
  • Narrow angles of the eyes
  • Adults, 19 years or older

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center, Department of Ophthalmology

Omaha, Nebraska, 68198-5540, United States

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Michael Feilmeier, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 1, 2011

First Posted

June 3, 2011

Study Start

August 5, 2011

Primary Completion

February 12, 2014

Study Completion

February 12, 2014

Last Updated

August 28, 2023

Record last verified: 2023-08

Locations

US(1)