Novel Diagnostics With Optical Coherence Tomography: Imaging the Anterior Eye

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00343473
First received: June 19, 2006
Last updated: July 25, 2011
Last verified: July 2011
  Purpose

The purpose of this research is to evaluate the optical coherence tomography (OCT), to image diseases of the eye. OCT may be useful for the early diagnosis and monitoring of a variety of diseases involving the eye, such as Fuch's Dystrophy (type of eye disease) and retinal damage (eye diseases in the back of the eye) due to diabetes.


Condition Phase
Fuch's Dystrophy
Corneal Disorders
Prior Surgery
Phase 1

Study Type: Observational
Official Title: Novel Diagnostics With Optical Coherence Tomography: Imaging of the Anterior Eye

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Estimated Enrollment: 200
Study Start Date: October 2005
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Detailed Description:

The purpose of this research is to evaluate the optical coherence tomography (OCT), to image diseases of the eye. OCT may be useful for the early diagnosis and monitoring of a variety of diseases involving the eye, such as Fuch's Dystrophy (type of eye disease) and retinal damage (eye diseases in the back of the eye) due to diabetes. OCT may also be useful for assessing contact lens and surgical procedures, such as LASIK (type of ophthalmic surgical procedure). The OCT is Food and Drug Administration (FDA) approved. The ultra high OCT is a non-significant risk device (it does not present a possible serious risk to your health, your safety, or your welfare) that has not been approved by the FDA. This study will also be conducted at the Massachusetts Institute of Technology and Tufts-New England Medical Center New England Eye Center in Massachusetts

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects will range form 18 years to 90 years. Gender can be male or female. Will include 100 normals and 100 diseased patients that include diabetic retinopathy, macular degeneration, and glaucoma.

Criteria

Inclusion Criteria: Female Subjects who are pregnant or breastfeeding will be included (no risks to fetus).

Normals: Normal appearing cornea, no history of corneal trauma, surgery or disease, no historical or current contact lens wear. Thirty subjects from 6 different age groups (> 18 yrs; 20-30 yrs; 30-40 yrs; 40-50 yrs; 50-60 yrs; > 60 yrs) will be recruited to determine the normal variations in anterior eye structure.

LASIK patients: to participate as a LASIK patient, the subject is previously normal but may have worn contact lenses, and is scheduled to undergo LASIK.

Contact lens wearers: to participate as a contact lens wearer the patient otherwise fulfills all criteria specified for normalcy, with the exception of contact lens wear.

Fuchs' dystrophy patients: Fuchs' Dystrophy is characterized by guttata and clinically significant corneal edema, with a corneal thickness of >700 microns, and/or reduced visual acuity in the morning which improves over the course of the day.

Diabetic patients: for diabetic patients are specified in the posterior segment imaging section.

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Exclusion Criteria:Subjects will be excluded from the study if their media are opaque, or if they are unwilling or unable to participate in the study.

If participants choose they may also participate in other imaging research protocols. No risk is associated if entering multiple imaging protocols, while being a participant in this research study.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00343473

Contacts
Contact: Kristy A Truman, COA 412-383-8778 trumank@upmc.edu
Contact: Melessa Salay 412-383-9884 salaymd@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh UPMC Eye Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Sub-Investigator: Joel S Schuman, MD         
Principal Investigator: Gadi Wollstein, MD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Study Chair: Joel S Schuman, MD University of Pittsburgh
Study Director: Gadi Wollstein, MD University of Pittsburgh
Study Director: Hiroshi Ishikawa, MD University of Pittsburgh
  More Information

No publications provided by University of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Melessa Salay, UPMC Eye center
ClinicalTrials.gov Identifier: NCT00343473     History of Changes
Other Study ID Numbers: 0309020, Ro1 EY 11289-15
Study First Received: June 19, 2006
Last Updated: July 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Fuch's dystrophy
corneal disorders
cornea
lasik
refractive surgery

Additional relevant MeSH terms:
Corneal Diseases
Fuchs' Endothelial Dystrophy
Eye Diseases
Corneal Dystrophies, Hereditary
Eye Diseases, Hereditary
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on September 14, 2014