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

Carl Zeiss Meditec

Status: Completed

Conditions: Age Related Macular Degeneration; Geographic Atrophy

Study type: Observational

Funder types: Industry

Identifiers

NCT01272076

HD-OCT-GA-2010-1-v2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

85 participants in 1 patient group

Dry AMD and geographic atrophy

Description:

Patients diagnosed with dry AMD and geographic atrophy