Measurement and Analysis of Macular Retinal Pigment Epithelium (RPE) Elevations With Cirrus HD-OCT vs. Color Fundus Photography

This study has been completed.
Sponsor:
Collaborator:
DataMed Devices Inc.
Information provided by (Responsible Party):
Carl Zeiss Meditec, Inc.
ClinicalTrials.gov Identifier:
NCT01272063
First received: January 5, 2011
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

The objective of this study is to compare the areas designated as elevated retinal pigment epithelium (RPE) by the Cirrus HD-OCT versus those designated as drusen on color fundus photographs (CFPs).


Condition
Drusen Stage Macular Degeneration

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Measurement and Analysis of Macular Retinal Pigment Epithelium (RPE) Elevations With Cirrus HD-OCT vs. Color Fundus Photography

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To compare area measurements of elevated RPE as observed in the Cirrus HD-OCT versus those designated as drusen on color fundus photographs. [ Time Frame: Study was released before December 1, 2012 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To describe the clinical factors that affected the automated segmentation of elevated RPE by the Cirrus HD-OCT. [ Time Frame: Study was released before December 1, 2012 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • To describe the qualitative similarities and differences between the areas designated as elevated RPE by the Cirrus HD-OCT versus those designated as drusen on color fundus photographs. [ Time Frame: Study was released before December 1, 2012 ] [ Designated as safety issue: No ]

Enrollment: 91
Study Start Date: November 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Dry AMD with macular drusen
Patients diagnosed with dry AMD with macular drusen

Detailed Description:

This is a prospective, multiple site study. Ocular history and examination will be conducted on consented subjects to determine further participation in the study. Subjects qualified to continue will undergo color fundus photography and imaging of their study eye using the Cirrus HD-OCT.

  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 or older diagnosed to have dry AMD with macular drusen.
  • Drusen should not be combined with other lesions such as geographic atrophy (GA) or choroidal neovascularization.
  • Able and willing to make the required study visits.
  • 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 visits.
  • Unable to give consent or follow study instructions.
  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: NCT01272063

Locations
United States, California
East Bay Retina
Oakland, California, United States, 94609
West Coast Retina
San Francisco, California, United States, 94107-1756
United States, Florida
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
United States, Michigan
TLC Eyecare and Laser Centers
Lansing, Michigan, United States, 48912
Sponsors and Collaborators
Carl Zeiss Meditec, Inc.
DataMed Devices Inc.
Investigators
Principal Investigator: Philip Rosenfeld, MD Bascom Palmer Eye Institute
Principal Investigator: Carmelina Gordon, MD TLC Eyecare and Laser Center
Principal Investigator: Eugene Lit, MD East Bay Retina Consultants
Principal Investigator: Brandon Lujan, MD West Coast Retina
  More Information

Publications:
Klein R, Cruickshanks KJ, Nash SD, Krantz EM, Javier NF, Huang GH, Pankow JS, Klein BE. The prevalence of age-related macular degeneration and associated risk factors. Arch Opthalmol 2010; 128:750-8.
Varma R, Azen SP, McKean-Cowdin R, Paz SH, Torres M, Barrera J, Choudhury F, Cisneros L, Chung J, Corona E, Cuestas C, Dzekov J, Foong AW, Lastra C, Lai MY, Martinez G, Shtir C, Smith RE, Tetrow L, Wang Y, Wu J, John L, Tucker K, Klein R, Meuer SE, Knutson MD, Neider M. Four-year incidence and progression of age-related macular degeneration: the Los Angeles Latino Eye Study. Am J Ophthalmol 2010; 149(5):741-51.
Jain N, Farsiu S, Khanifar AA, Bearelly S, Smith RT, Izatt JA, Toth CA. Quantitative comparison of drusen segmented on SD OCT versus drusen delineated on color fundus photographs. Invest Ophthalmol Vis Sci 2010 (E-pub ahead of print).

Responsible Party: Carl Zeiss Meditec, Inc.
ClinicalTrials.gov Identifier: NCT01272063     History of Changes
Other Study ID Numbers: HD-OCT-DR-2010-1
Study First Received: January 5, 2011
Last Updated: June 24, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 28, 2014