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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carl Zeiss Meditec, Inc.
ClinicalTrials.gov Identifier:
NCT01272076
First received: January 5, 2011
Last updated: December 17, 2013
Last verified: December 2013

January 5, 2011
December 17, 2013
January 2011
February 2011   (final data collection date for primary outcome measure)
Difference in mm Squared of Cirrus HD-OCT Automated Measurements of the Illumination Areaa Under the RPE to Expert Manual Measurement of Areas of Hypofluorescence Typical of Geographic Atrophy (GA). [ Time Frame: August 2011 ] [ Designated as safety issue: No ]
In retinal areas with atrophy, light emitted from the Cirrus penetrates the sclera and choroid which are more reflecting compared with the Retinal Pigment Epithelium (RPE). The areas with higher illumination are associated with areas of Geographic Atrophy (GA), and allow to quantify how big is the area of atrophy. The study will assess the difference between Cirrus HD-OCT measurements of areas of increased illumination under the RPE to hypofluorescence areas on fundus photos as assessed manually by retina specialists.
Not Provided
Complete list of historical versions of study NCT01272076 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Cirrus HD-OCT Measurement of Area of Increased Light Penetration Under the Retinal Pigment Epithelium (RPE)
Cirrus HD-OCT Measurement of Area of Increased Light Penetration Under the Retinal Pigment Epithelium (RPE)

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.

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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Primary Care Clinic

  • Age Related Macular Degeneration
  • Geographic Atrophy
Not Provided
Dry AMD and geographic atrophy
Patients diagnosed with dry AMD and geographic atrophy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
85
February 2011
February 2011   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01272076
HD-OCT-GA-2010-1-v2
Yes
Carl Zeiss Meditec, Inc.
Carl Zeiss Meditec, Inc.
Not Provided
Principal Investigator: Carmelina M Gordon, MD TLC Eye Care and Laser Center
Principal Investigator: Eugene S Lit, M.D. East Bay Retina Consultants
Carl Zeiss Meditec, Inc.
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP