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OpenTrials
Completed

NCT Number: NCT01890187

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

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).

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

West Coast Retina

Walnut Creek, California, 94107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Coefficient of variation for area of increased illumination under the RPE (mm^2)

    Time frame: Single visit observation

Secondary outcomes

  1. Coefficient of variation of the closest distance to fovea

    Time frame: Single visit observation

Sponsors and collaborators

Lead sponsor

Carl Zeiss Meditec, Inc.

Industry

Collaborators

  • DataMed Devices Inc.

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 1, 2013
Registry last updated
Jul 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.