Screening Aid to Identify Corneas That May Have Pathologies or Other Conditions
NCT ID: NCT00396188
Last Updated: 2015-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
769 participants
OBSERVATIONAL
2007-02-28
2008-02-29
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Myopic Laser Vision Correction
Patients who have undergone myopic:
1. LASIK
2. PRK
3. LASEK
No interventions assigned to this group
Hyperopic Laser Vision Correction
Patients who have undergone hyperopic:
1. LASIK
2. PRK
3. LASEK
No interventions assigned to this group
Orthokeratology
1\. Patients using specially designed rigid contact lenses to reshape the cornea to temporarily reduce or eliminate refractive error.
No interventions assigned to this group
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.).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Any active infection or inflammation of the cornea.
* PI decides that subject is not suitable due to medical risk.
18 Years
ALL
Yes
Sponsors
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Carl Zeiss Meditec, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jon Dishler, M. D.
Role: PRINCIPAL_INVESTIGATOR
Dishler Laser Institute
David J Schanzlin, M. D.
Role: PRINCIPAL_INVESTIGATOR
Shiley Eye Center-University of California San Diego
Dennis Burger, O. D.
Role: PRINCIPAL_INVESTIGATOR
Kaiser Permanente, Oakland
Patrick Caroline, COT
Role: PRINCIPAL_INVESTIGATOR
Pacific University
Tyson Brunstetter, O. D.
Role: PRINCIPAL_INVESTIGATOR
Naval Training Center-Refractive Surgery Clinic
Kevin Reeder, O.D.
Role: PRINCIPAL_INVESTIGATOR
Carmel Mountain Vision Care Center
Locations
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Shiley Eye Center-University of California San Diego
La Jolla, California, United States
Carmel Mountain Vision Care Center
San Diego, California, United States
Dishler Laser Institute
Greenwood Village, Colorado, United States
Pacific University
Forest Grove, Oregon, United States
Countries
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References
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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.
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.
Other Identifiers
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Atlas II-2006-1-v1
Identifier Type: -
Identifier Source: org_study_id
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