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Corneal Topographer Fluorescein Patterns

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by University of Iowa.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00584285
First received: December 21, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Keratoconus
 Other: Comparison of fluorescein patterns

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Objective and Subjective Correlation Between Clinical Fluoroscein Patterns and Theoretical Patterns Using the Medmont Corneal Topographer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • There will be no inter-patient comparison. Bearing and elevation fluorescein patterns will be compared between the actual (photo) and theoretical (computer generated) fluorescein patterns. [ Time Frame: 1 year after last subject is enrolled ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improved comfort [ Time Frame: one day ] [ Designated as safety issue: No ]

Estimated Enrollment: 0
Study Start Date: November 2007
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Other: Comparison of fluorescein patterns
Compare conventional contact lens fitting to fitting contact lenses based on corneal topography measurement

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Concommittant corneal disease or surgery Inability to capture topography measurement

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584285

Contacts
Contact: Christine W Sindt, OD 319-356-4816 christine-sindt@uiowa.edu

Locations
United States, Iowa
University of Iowa Hospitals and Clinics - Dept. of Ophthalmology Recruiting
Iowa City, Iowa, United States, 52242
Principal Investigator: Christine W Sindt, OD            
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Christine W. Sindt, OD University of Iowa
  More Information

No publications provided

Responsible Party: Christine Sindt, OD, University of Iowa
ClinicalTrials.gov Identifier: NCT00584285     History of Changes
Other Study ID Numbers: 200709737
Study First Received: December 21, 2007
Last Updated: December 21, 2007
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013