Status:
COMPLETED
Screening Aid to Identify Corneas That May Have Pathologies or Other Conditions
Lead Sponsor:
Carl Zeiss Meditec, Inc.
Conditions:
Corneal Diseases
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to determine the ability of a proprietary software screening tool to discriminate normal corneas (front surface of the eye) from previously diagnosed corneal conditions (d...
Detailed Description
1. To establish reference values for SF, CIM, and TKM in subjects with normal corneas. 2. To establish reference values for SF, CIM, and TKM in subjects who underwent myopic laser vision correction. 3...
Eligibility Criteria
Inclusion
- Normals
- Patients seeking initial laser vision correction that were screened to be good candidates for the procedure.
- No history of refractive or other ocular surgery.
- No corneal pathologies.
- Normal corneal topography.
- Contact lens wearers should discontinue use at least 2 weeks for hard contacts, and 3 days for soft lenses prior to imaging.
- Keratoconus
- An irregular cornea determined by distorted keratometry mires, distortion of the retinoscopic, or ophthalmoscopic red reflex (or a combination of these)
- At least one of the following biomicroscopic signs: Vogt's striae, Fleischer's ring of \>2 mm arc, or corneal scarring consistent with keratoconus.
- Contact lens wearers should discontinue use preferably 1 day or at least half an hour prior to imaging.
- Myopic Laser Vision Correction
- Patients who have undergone myopic:
- LASIK
- PRK
- LASEK
- Hyperopic Laser Vision Correction
- Patients who have undergone hyperopic:
- LASIK
- PRK
- LASEK
- Orthokeratology
- Patients using specially designed rigid contact lenses to reshape the cornea to temporarily reduce or eliminate refractive error.
- Subjects must be 18 years of age or older; able and willing to make the required visit; and able and willing to give consent.
Exclusion
- Patients that underwent corneal transplantation or any ocular surgery for the following categories: normal, keratoconus, and orthokeratology)
- Any active infection or inflammation of the cornea.
- PI decides that subject is not suitable due to medical risk.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
769 Patients enrolled
Trial Details
Trial ID
NCT00396188
Start Date
February 1 2007
End Date
February 1 2008
Last Update
August 17 2015
Active Locations (4)
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1
Shiley Eye Center-University of California San Diego
La Jolla, California, United States, 92093
2
Carmel Mountain Vision Care Center
San Diego, California, United States, 92129
3
Dishler Laser Institute
Greenwood Village, Colorado, United States, 80111
4
Pacific University
Forest Grove, Oregon, United States, 97116