Screening Aid to Identify Corneas That May Have Pathologies or Other Conditions

Completed

Conditions studied: Corneal Diseases

In brief

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 (diseases/surgeries/pathologies) and to determine the repeatabiltity and reproducibility of the Atlas II corneal topographer in normal human corneas.

Key facts

Study ID

NCT00396188

Run by

Carl Zeiss Meditec, Inc.

People needed

769

Starts

2007-02-01

Expected to finish

2008-02-01

Last updated by the study team

2015-08-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Shiley Eye Center-University of California San Diego — La Jolla, California, United States
• Carmel Mountain Vision Care Center — San Diego, California, United States
• Dishler Laser Institute — Greenwood Village, Colorado, United States
• Pacific University — Forest Grove, Oregon, United States

Full record on ClinicalTrials.gov

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