Corneal Topographer Fluorescein Patterns

March 7, 2018 updated by: Christine Sindt

Objective and Subjective Correlation Between Clinical Fluorescein Patterns and Theoretical Patterns Using the Medmont Corneal Topographer

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Subject population: keratoconus patients who have not undergone corneal surgery 100 subjects who come to UIHC for their contact lens care. We will approach them at their visit. We will not call potential participants from a database.

If topography is impossible to capture. Concommitant Corneal Disease Minors will be excluded

Study Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics - Dept. of Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

Noncommittant corneal disease or surgery Inability to capture topography measurement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With an Observable Difference Between Virtual Versus Actual Fluorescein Patterns
Time Frame: Baseline first visit
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christine Sindt

Investigators

  • Principal Investigator: Christine W. Sindt, OD, University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2007

Primary Completion (Actual)

September 4, 2009

Study Completion (Actual)

September 14, 2009

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (Estimate)

January 2, 2008

Study Record Updates

Last Update Posted (Actual)

November 2, 2018

Last Update Submitted That Met QC Criteria

March 7, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200709737

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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