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
  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
Age Related Macular Degeneration
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:


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

Primary Outcome Measures:
  • 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.


Enrollment: 85
Study Start Date: January 2011
Study Completion Date: February 2011
Primary Completion Date: February 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.
Oakland, California, United States, 94609
United States, Michigan
TLC Eyecare and Laser Centers
Jackson, Michigan, United States, 49202
Sponsors and Collaborators
Carl Zeiss Meditec, Inc.
Investigators
Principal Investigator: Carmelina M Gordon, MD TLC Eye Care and Laser Center
Principal Investigator: Eugene S Lit, M.D. East Bay Retina Consultants
  More Information

Publications:
Responsible Party: 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
Results First Received: June 24, 2013
Last Updated: December 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Carl Zeiss Meditec, Inc.:
Age Related Macular Degeneration
Geographic Atrophy
Imaging
OCT

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

ClinicalTrials.gov processed this record on April 17, 2014