Corneal Topographer Fluorescein Patterns - Full Text View

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

Drug Information available for:

Fluorescein D&C Yellow no. 8

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Open Label, Single Group Assignment

Official Title:	Objective and Subjective Correlation Between Clinical Fluoroscein Patterns and Theoretical Patterns Using the Medmont Corneal Topographer

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
1: Active Comparator	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

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

Study placed in the following topic categories:

Corneal Diseases

Eye Diseases

Keratoconus

ClinicalTrials.gov processed this record on October 28, 2008

Sponsored by:	University of Iowa
Information provided by:	University of Iowa
ClinicalTrials.gov Identifier:	NCT00584285