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Cirrus HD-OCT Measurement of Area of Increased Light Penetration Under the Retinal Pigment Epithelium (RPE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Carl Zeiss Meditec, Inc..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
DataMed Devices Inc.
Information provided by:
Carl Zeiss Meditec, Inc.
ClinicalTrials.gov Identifier:
NCT01272076
First received: January 5, 2011
Last updated: January 6, 2011
Last verified: January 2011
History of Changes
  Purpose

The objective of this study is to compare Cirrus HD-OCT automated measurements of the illumination area under the retinal pigment epithelium (RPE) to expert manual measurements of areas of hypofluorescence typical of geographic atrophy in fundus autofluorescence (FAF) images.


Condition
Dry AMD
Geographic Atrophy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cirrus HD-OCT Measurement of Area of Increased Light Penetration Under the Retinal Pigment Epithelium (RPE)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Carl Zeiss Meditec, Inc.:

Estimated Enrollment: 100
Study Start Date: November 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Dry AMD and geographic atrophy
Patients diagnosed with dry AMD and geographic atrophy

Detailed Description:

Specific Objectives:

  1. To compare Cirrus HD-OCT automated measurements of the illumination area under the RPE to expert manual measurements of areas of hypofluorescence typical of geographic atrophy in fundus autofluorescence (FAF) images.
  2. To describe the differences and similarities between Cirrus HD-OCT and fundus autofluorescence images of subjects with geographic atrophy secondary to dry age-related macular degeneration (AMD).
  3. To determine the clinical factors that affect the Cirrus HD-OCT automated measurements of the illumination area under the RPE.
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary Care Clinic

Criteria

Inclusion Criteria:

  • Males or females 50 years of age and older diagnosed to have advanced dry AMD with geographic atrophy.

  • Geographic atrophy lesions should:

    • Not be greater than 5 mm at the widest diameter. The entire lesion(s) should fit into the 6x6 mm scan area of the Cirrus HD-OCT.
    • Not be smaller than 1.25 mm2.
    • Not be confluent with peri-papillary atrophy.
    • Not be combined with other lesions such as CNVs.
  • Able and willing to make the required study visit.
  • Able and willing to give consent and follow study instructions.

Exclusion Criteria:

  • History of retinal surgery, laser photocoagulation, and/or radiation therapy to the eye.
  • Evidence of other retinal diseases of the eye, including wet AMD, diabetic retinopathy, diabetic macular edema, or significant vitreomacular traction upon dilated examination, or upon evaluation of retinal photos.
  • Thick media opacity or inability to fixate that precludes obtaining acceptable scans.
  • Concomitant use of hydrochloroquine and chloroquine.
  • Unable to make the required study visit.
  • Unable to give consent or follow study instructions.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272076

Locations
United States, California
East Bay Retina Consultants, Inc. Recruiting
Oakland, California, United States, 94609
Contact: Scotty Renslow     510-444-1600     renslowscotty@hotmail.com    
Principal Investigator: Eugene Lit, MD            
United States, Florida
Bascom Palmer Eye Institute Recruiting
Miami, Florida, United States, 33136
Contact: Cristy Lage-Rodriguez     305-326-6117     CLage@med.miami.edu    
Principal Investigator: Philip Rosenfeld, MD            
United States, Michigan
TLC Eyecare and Laser Centers Recruiting
Jackson, Michigan, United States, 49202
Contact: Shellie Fuentes     517-782-1213     Shellie.Fuentes@tlcmi.com    
Principal Investigator: Carmelina Gordon, MD            
Sponsors and Collaborators
Carl Zeiss Meditec, Inc.
DataMed Devices Inc.
  More Information

Publications:

Responsible Party: Judith A. Brimacombe, Carl Zeiss Meditec, Inc.
ClinicalTrials.gov Identifier: NCT01272076     History of Changes
Other Study ID Numbers: HD-OCT-GA-2010-1-v2
Study First Received: January 5, 2011
Last Updated: January 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Carl Zeiss Meditec, Inc.:
Dry AMD
Geographic Atrophy
Imaging
OCT

Additional relevant MeSH terms:
Atrophy
Geographic Atrophy
Pathological Conditions, Anatomical
Macular Degeneration
 Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013