NCT00584285

Brief Summary

The objective of this study is to determine if corneal topography can be used to predict the fluorescein pattern of keratoconus lenses on the eye. A corneal topography image will be taken and the computer selected lens will be placed on the eye. After placement of the lens color photographs will be taken of the eye's fluorescein pattern and compared to the computer predicted pattern.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2007

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

September 15, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 2, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2009

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2009

Completed
9.1 years until next milestone

Results Posted

Study results publicly available

November 2, 2018

Completed
Last Updated

November 2, 2018

Status Verified

March 1, 2018

Enrollment Period

2 years

First QC Date

December 21, 2007

Results QC Date

March 31, 2017

Last Update Submit

March 7, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With an Observable Difference Between Virtual Versus Actual Fluorescein Patterns

    Comparison of fluorescein patterns of rgp contact lens. Bearing and elevation fluorescein patterns will be compared between the actual (photo) and theoretical (computer generated) fluorescein patterns using standard clinical means.

    Baseline first visit

Study Arms (1)

Corneal Topographer Fluorescein Patterns

Use corneal topography to evaluate fluorescein pattern of rgp contact lens. Used corneal topography to develop theoretical fluorescein patters on a virtual eye. Theoretical lens developed by the topographer was ordered to compare to the actual fluorescein pattern on the actual eye.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

18 yrs of age or older with diagnosis of keratoconus and contact lens wearer

You may qualify if:

  • yrs of age or older with diagnosis of keratoconus and contact lens wearer

You may not qualify if:

  • Noncommittant corneal disease or surgery Inability to capture topography measurement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa Hospitals and Clinics - Dept. of Ophthalmology

Iowa City, Iowa, 52242, United States

Location

Related Publications (5)

  • Szczotka LB. Clinical evaluation of a topographically based contact lens fitting software. Optom Vis Sci. 1997 Jan;74(1):14-9. doi: 10.1097/00006324-199701000-00015.

    PMID: 9148262BACKGROUND
  • Jani BR, Szczotka LB. Efficiency and accuracy of two computerized topography software systems for fitting rigid gas permeable contact lenses. CLAO J. 2000 Apr;26(2):91-6.

    PMID: 10810939BACKGROUND
  • Rabinowitz YS, Garbus JJ, Garbus C, McDonnell PJ. Contact lens selection for keratoconus using a computer-assisted videophotokeratoscope. CLAO J. 1991 Apr;17(2):88-93.

    PMID: 2049828BACKGROUND
  • Szczotka LB. Corneal topography and contact lenses. Ophthalmol Clin North Am. 2003 Sep;16(3):433-53. doi: 10.1016/s0896-1549(03)00054-3.

    PMID: 14564765BACKGROUND
  • Bufidis T, Konstas AG, Mamtziou E. The role of computerized corneal topography in rigid gas permeable contact lens fitting. CLAO J. 1998 Oct;24(4):206-9.

    PMID: 9800058BACKGROUND

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Results Point of Contact

Title
Dr. Christine W. Sindt
Organization
University of Iowa

Study Officials

  • Christine W. Sindt, OD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Asscociate Professor

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 2, 2008

Study Start

September 15, 2007

Primary Completion

September 4, 2009

Study Completion

September 14, 2009

Last Updated

November 2, 2018

Results First Posted

November 2, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations