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

August 13, 2015 updated by: Carl Zeiss Meditec, Inc.

Corneal Analysis - Pathology Detection Aid

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.

Study Overview

Status

Completed

Conditions

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. 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).

Study Type

Observational

Enrollment (Actual)

769

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • Shiley Eye Center-University of California San Diego
      • San Diego, California, United States, 92129
        • Carmel Mountain Vision Care Center
    • Colorado
      • Greenwood Village, Colorado, United States, 80111
        • Dishler Laser Institute
    • Oregon
      • Forest Grove, Oregon, United States, 97116
        • Pacific University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reference values of normal and previously diagnosed corneal conditions by Atlas II corneal topographer
Time Frame: 1-2 hours
1-2 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Repeatabiltity and reproducibility of the Atlas II corneal topographer in human corneas
Time Frame: 1-2 hours
1-2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (ACTUAL)

February 1, 2008

Study Completion (ACTUAL)

February 1, 2008

Study Registration Dates

First Submitted

November 2, 2006

First Submitted That Met QC Criteria

November 3, 2006

First Posted (ESTIMATE)

November 6, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

August 17, 2015

Last Update Submitted That Met QC Criteria

August 13, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Atlas II-2006-1-v1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Corneal Diseases

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe