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

NCT00396188 | Completed DMC

• 1 other identifier: Atlas II-2006-1-v1
• Study Type: observational
• Target: 769
• Locations: 1 country
• Sites: 4

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.

Conditions

Corneal Diseases

Keywords

Keratoconus; LASIK; Orthokeratology; Pellucid Marginal Degeneration; Refractive Surgery; normal cornea; post myopic LASIK; post hyperopic LASIK; corneal pathologies (e.g. pellucid marginal degeneration)

Outcome Measures

Primary Outcomes (1)

• Reference values of normal and previously diagnosed corneal conditions by Atlas II corneal topographer

  1-2 hours

Secondary Outcomes (1)

• Repeatabiltity and reproducibility of the Atlas II corneal topographer in human corneas

  1-2 hours

Study Arms (6)

Normals

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

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

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

Hyperopic Laser Vision Correction

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will consist of patients seeking consult in the Principal Investigator's (PI) clinical practice and volunteers responding to the study's advertisements.

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

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.

Sponsors & Collaborators

• Carl Zeiss Meditec, Inc.: lead

Study Sites (4)

Shiley Eye Center-University of California San Diego

La Jolla, California, 92093, United States

Location

Carmel Mountain Vision Care Center

San Diego, California, 92129, United States

Location

Dishler Laser Institute

Greenwood Village, Colorado, 80111, United States

Location

Pacific University

Forest Grove, Oregon, 97116, United States

Location

Related Publications (2)

• Zadnik K, Barr JT, Edrington TB, Everett DF, Jameson M, McMahon TT, Shin JA, Sterling JL, Wagner H, Gordon MO. Baseline findings in the Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study. Invest Ophthalmol Vis Sci. 1998 Dec;39(13):2537-46.

  PMID: 9856763 BACKGROUND

• Twa MD, Parthasarathy S, Roberts C, Mahmoud AM, Raasch TW, Bullimore MA. Automated decision tree classification of corneal shape. Optom Vis Sci. 2005 Dec;82(12):1038-46. doi: 10.1097/01.opx.0000192350.01045.6f.

  PMID: 16357645 BACKGROUND

MeSH Terms

Conditions

Corneal Diseases; Keratoconus

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2006
• First Posted: November 6, 2006
• Study Start: February 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: August 17, 2015

Record last verified: 2015-08

Locations

US (4)