NCT00894192

Brief Summary

The purpose of this study is to assess the level of visual functioning in patients with various eye conditions while wearing different types of eyeglasses.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

May 6, 2009

Status Verified

May 1, 2009

Enrollment Period

8 months

First QC Date

May 4, 2009

Last Update Submit

May 5, 2009

Conditions

Visual Function

Keywords

This study tests functional ability of patients with refractive error or normal vision while using different types of eyeglasses.

Outcome Measures

Primary Outcomes (1)

  • Visual Acuity, and Contrast Sensitivity

    Once a week

Study Arms (2)

Wavefront guided lenses

ACTIVE COMPARATOR
Device: Izon Wavefront-guided lenses

Conventional lenses

PLACEBO COMPARATOR
Device: Conventional lenses

Interventions

Izon Wavefront-guided lensesDEVICE

Subjects will use prescribed eyeglasses for one week. Their visual functioning will be tested at the end of the week.

Wavefront guided lenses
Conventional lensesDEVICE

We will test the subjects with these lenses after they have worn them for one week. Same procedures will be followed as with the other lenses.

Conventional lenses

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Have normal vision
  • Are far-sighted or near-sighted
  • Have no eye diseases Subjects aged 18 and over, who have refractive errors ranging from +5.0 to -5.0 and/or who have eye disease will be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chicago Lighthouse

Chicago, Illinois, 60608, United States

RECRUITING

Central Study Contacts

Samar Suleman, BA

CONTACT

312-447-3234samar.suleman@chicagolighthouse.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 4, 2009

First Posted

May 6, 2009

Study Start

February 1, 2009

Primary Completion

October 1, 2009

Study Completion

December 1, 2009

Last Updated

May 6, 2009

Record last verified: 2009-05

Locations

US(1)