Repeatability and Reproducibility of Cirrus HD-OCT Measurements of Illumination Areas Under the Retinal Pigment Epithelium

Carl Zeiss Meditec

Status: Completed

Conditions: Advanced Dry AMD With Geographic Atrophy

Study type: Observational

Funder types: Industry

Identifiers

NCT01890187

HD-OCT-GA-2010-2

Details and patient eligibility

About

The objective of this study is to determine the repeatability and reproducibility of the Cirrus HD-OCT measurement of illumination areas under the retinal pigment epithelium (RPE).

Full description

This is a prospective, single site study. Ocular history and examination will be conducted on consented subjects to determine further participation in the study. The study will be divided into two phases. In Phase 1, the inter-device variability of Cirrus HD-OCT measurements of illumination areas under the RPE will be determined. In Phase 2, the inter-operator variability of Cirrus HD-OCT measurements of illumination areas under the RPE will be determined. In each of these phases, the Macular Cube 200 x 200 scan and the Macular Cube 512 x 128 scan will be evaluated.

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 CNV.

• 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.
• Thick media opacity or inability to fixate that precludes obtaining acceptable scans.
• Concomitant use of hydrochloroquine or chloroquine.
• Unable to make the required study visits.
• Unable to give consent or follow study instructions.

Trial design

85 participants in 1 patient group

Advanced dry AMD with geographic atrophy

Description:

Patients diagnosed with advanced dry AMD with geographic atrophy