NCT01342393

Brief Summary

Proof of concept study is to compare the best corrected visual acuity obtained via First-Sight lenses with the clinical "gold standard" of manifest refraction and autorefraction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

January 11, 2012

Status Verified

January 1, 2012

Enrollment Period

4 months

First QC Date

April 25, 2011

Last Update Submit

January 9, 2012

Conditions

Refractive Error

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
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 19 years of age and older.
  • 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 the patient's medical records.
  • Best corrected visual acuity (BCVA) of 20/20 with manifest 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
  • years of age and younger

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center, Department of Ophthalmology

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Michael Feilmeier, MD

    UNMC Department of Ophthalmology and Visual Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2011

First Posted

April 27, 2011

Study Start

April 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

January 11, 2012

Record last verified: 2012-01

Locations

US(1)