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

Carl Zeiss Meditec

Status: Completed

Conditions: Corneal Diseases

Study type: Observational

Funder types: Industry

Identifiers

NCT00396188

Atlas II-2006-1-v1

Details and patient eligibility

About

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.

Full 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. To establish reference values for SF, CIM, and TKM in subjects who underwent hyperopic laser vision correction.
4. To establish reference values for SF, CIM, and TKM in subjects who were diagnosed to have keratoconus.
5. To establish reference values for SF, CIM, and TKM in subjects with history of orthokeratology.
6. 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.
7. To determine the repeatabiltity and reproducibility of the Atlas II corneal topographer in normal human corneas using true elevation data and axial curvature.
8. 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).

Enrollment: 769 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

769 participants in 6 patient groups

Normals

Description:

1. Patients seeking initial laser vision correction that were screened to be good candidates for the procedure. 2. No history of refractive or other ocular surgery. 3. No corneal pathologies. 4. Normal corneal topography. 5. Contact lens wearers should discontinue use at least 2 weeks for hard contacts, and 3 days for soft lenses prior to imaging.

Keratoconus

Description:

1. An irregular cornea determined by distorted keratometry mires, distortion of the retinoscopic, or ophthalmoscopic red reflex (or a combination of these) 2. At least one of the following biomicroscopic signs: Vogt's striae, Fleischer's ring of \>2 mm arc, or corneal scarring consistent with keratoconus. 3. Contact lens wearers should discontinue use preferably 1 day or at least half an hour prior to imaging.

Myopic Laser Vision Correction

Description:

Patients who have undergone myopic: 1. LASIK 2. PRK 3. LASEK

Hyperopic Laser Vision Correction

Description:

Patients who have undergone hyperopic: 1. LASIK 2. PRK 3. LASEK

Orthokeratology

Description:

1. Patients using specially designed rigid contact lenses to reshape the cornea to temporarily reduce or eliminate refractive error.

Others

Description:

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.).