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Completed

NCT Number: NCT00396188

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shiley Eye Center-University of California San Diego, La Jolla, California, United States

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About this study

  • 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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 1-2 hours

Secondary outcomes

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

    Time frame: 1-2 hours

Sponsors and collaborators

Lead sponsor

Carl Zeiss Meditec, Inc.

Industry

Registry information

Official study title

Corneal Analysis - Pathology Detection Aid

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Nov 6, 2006
Registry last updated
Aug 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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