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

Sponsor

Carl Zeiss Meditec, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00396188

Collaborator

(none)

769

Enrollment

Locations

Duration (Months)

192.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Corneal Diseases

Detailed Description

To establish reference values for SF, CIM, and TKM in subjects with normal corneas.
To establish reference values for SF, CIM, and TKM in subjects who underwent myopic laser vision correction.
To establish reference values for SF, CIM, and TKM in subjects who underwent hyperopic laser vision correction.
To establish reference values for SF, CIM, and TKM in subjects who were diagnosed to have keratoconus.
To establish reference values for SF, CIM, and TKM in subjects with history of orthokeratology.
To establish reference values for SF, CIM, and TKM in subjects with previously diagnosed corneal conditions (diseases/pathologies/surgeries) affecting the corneal surface that are not listed above.
To determine the repeatabiltity and reproducibility of the Atlas II corneal topographer in normal human corneas using true elevation data and axial curvature.
To determine the sensitivity, specificity, and accuracy of the Pathfinder II Corneal Analysis software in discriminating normal corneas from previously diagnosed corneal conditions (diseases/pathologies/surgeries) affecting the corneal surface (Phase II).

Study Design

Study Type:

Observational

Actual Enrollment :

769 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Corneal Analysis - Pathology Detection Aid

Study Start Date :

Feb 1, 2007

Actual Primary Completion Date :

Feb 1, 2008

Actual Study Completion Date :

Feb 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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 1. Patients using specially designed rigid contact lenses to reshape the cornea to temporarily reduce or eliminate refractive error.
Others 1. Corneal conditions (diseases/ pathologies/surgeries) that can potentially affect the corneal surface that are not listed above (e.g. pellucid marginal degeneration; postoperative corneal transplant, intra-corneal ring segments, refractive keratotomy, conductive keratoplasty; peripheral ulcerative keratitis, Terrien's marginal degeneration; etc.).

Outcome Measures

Primary Outcome Measures

Reference values of normal and previously diagnosed corneal conditions by Atlas II corneal topographer [1-2 hours]

Secondary Outcome Measures

Repeatabiltity and reproducibility of the Atlas II corneal topographer in human corneas [1-2 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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

Sponsors and Collaborators

Carl Zeiss Meditec, Inc.

Investigators

Principal Investigator: Jon Dishler, M. D., Dishler Laser Institute
Principal Investigator: David J Schanzlin, M. D., Shiley Eye Center-University of California San Diego
Principal Investigator: Dennis Burger, O. D., Kaiser Permanente, Oakland
Principal Investigator: Patrick Caroline, COT, Pacific University
Principal Investigator: Tyson Brunstetter, O. D., Naval Training Center-Refractive Surgery Clinic
Principal Investigator: Kevin Reeder, O.D., Carmel Mountain Vision Care Center