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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00584285
Other study ID # 200709737
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 15, 2007
Est. completion date September 14, 2009

Study information

Verified date March 2018
Source University of Iowa
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date September 14, 2009
Est. primary completion date September 4, 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Iowa Hospitals and Clinics - Dept. of Ophthalmology Iowa City Iowa

Sponsors (1)

Lead Sponsor Collaborator
Christine Sindt

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

Szczotka LB. Clinical evaluation of a topographically based contact lens fitting software. Optom Vis Sci. 1997 Jan;74(1):14-9. — View Citation

Szczotka LB. Corneal topography and contact lenses. Ophthalmol Clin North Am. 2003 Sep;16(3):433-53. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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