Corneal DiseasesNCT00396188

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

An observational study of Corneal Diseases, run by Carl Zeiss Meditec, Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Corneal Diseases
How many people: 769 participants
Where: 4 sitesUnited States
Study dates: Feb 2007to Feb 2008
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

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.

Who may be able to join

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.

Show all 23Show fewer

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.

Who cannot join

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 locations and contacts

4 sites in 1 country.

United States4 sites

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

Other trials in United States

About this study

Official title: Corneal Analysis - Pathology Detection Aid

Read the detailed description

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).

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)
Medical subject headings: Corneal Diseases, Keratoconus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00396188
Study group	Role	What they receive
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 being measured

The primary outcome is the main question the study is designed to answer.

Reference values of normal and previously diagnosed corneal conditions by Atlas II corneal topographer
Measured: 1-2 hours

Secondary outcomes (1)

Repeatabiltity and reproducibility of the Atlas II corneal topographer in human corneas
Measured: 1-2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2007Feb 2008

First posted6 Nov 2006 (estimated)
Study startFeb 2007
Primary completionFeb 2008
Study completionFeb 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Corneal DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Cross-sectional
Enrolment: 769 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00396188
Sponsor's protocol ID: Atlas II-2006-1-v1
Status last verified: Aug 2015
First submitted: 2 Nov 2006
Last updated: 17 Aug 2015
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 9856763
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.
PubMed 16357645

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Corneal Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Corneal Analysis - Pathology Detection Aid
ClinicalTrials.gov ID: NCT00396188
Acronym / sponsor ID: Atlas II-2006-1-v1
Conditions: Corneal Diseases
Keywords: Keratoconus, LASIK, Orthokeratology, Pellucid Marginal Degeneration, Refractive Surgery, normal cornea, post myopic LASIK, post hyperopic LASIK
Study type: Observational
Recruitment status: Completed
Enrolment: 769 participants (actual)
Lead sponsor: Carl Zeiss Meditec, Inc.Industry (pharma, biotech, devices)
Study start: Feb 2007
Primary completion: Feb 2008 (actual)
Study completion: Feb 2008 (actual)
First posted: 6 Nov 2006 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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).

Study design

Observational model: Case-control
Time perspective: Cross-sectional
Number of arms: 6

Arm	Type	Receives
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.).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (23 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

1 secondary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2015.
Background: PubMed 9856763Zadnik 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.
Background: PubMed 16357645Twa 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.

Related trials for Corneal Diseases

Active, not recruitingPhase 3
Descemet Endothelial Thickness Comparison Trial II
Fuchs, Fuchs Dystrophy
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
RecruitingObservational study
Validation of Interleukins and Other Cytokines Together With OCT Imaging for Rapid Infectious Keratitis Assessment
Keratitis Bacterial, Keratitis Fungal
Not yet recruiting
A Single-Center Clinical Study Evaluating the Efficacy and Safety of Allogeneic Natural Killer (NK) Cell Transplantation for Mooren's Ulcer
Cornea Disease
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jon Dishler, M. D. principal investigator

Dishler Laser Institute

David J Schanzlin, M. D. principal investigator

Shiley Eye Center-University of California San Diego

Dennis Burger, O. D. principal investigator

Kaiser Permanente, Oakland

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Corneal Diseases, run by Carl Zeiss Meditec, Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reference values of normal and previously diagnosed corneal conditions by Atlas II corneal topographer (time frame: 1-2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00396188, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2015.