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

Completed

• Conditions: Age Related Macular Degeneration; Geographic Atrophy

• Registration Number: NCT01272076
• Lead Sponsor: Carl Zeiss Meditec, Inc.

Brief Summary

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.

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-05
• Study First Submitted QC: 2011-01-06
• Study First Posted: 2011-01-07
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Results First Submitted: 2013-06-24
• Results First Submitted QC: 2013-09-09
• Results First Posted: 2013-11-14
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-17
• Last Update Posted: 2014-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).	August 2011	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.

Trial Locations

Locations (2)

TLC Eyecare and Laser Centers; 🇺🇸 Jackson, Michigan, United States

East Bay Retina Consultants, Inc.; 🇺🇸 Oakland, California, United States