Clinical trial NCT01890174: Repeatability and Reproducibility of Cirrus HD-OCT Macular Retinal Pigment Epithelium Elevation
Official title: Repeatability and Reproducibility of Cirrus HD-OCT Macular Retinal Pigment Epithelium Elevation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry AMD With Macular Drusen
Lead sponsor: Carl Zeiss Meditec, Inc.
Sponsor class: INDUSTRY
Collaborators: name: DataMed Devices Inc.
First posted: 2013-07-01
Enrollment: 54
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: The objective of this study is to determine the repeatability and reproducibility of the Cirrus HD-OCT measurements of drusen area and volume.

Detailed 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 drusen area and volume will be determined. In Phase 2, the inter-operator variability of Cirrus HD-OCT measurements of drusen area and volume 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.

Eligibility criteria: Inclusion Criteria:

1. Males or females 50 years of age or older diagnosed to have dry AMD with macular drusen.
2. Drusen should not be combined with other lesions such as geographic atrophy (GA) or choroidal neovascularization.
3. Able and willing to make the required study visits.
4. Able and willing to give consent and follow study instructions.

Exclusion Criteria:

1. History of retinal surgery, laser photocoagulation, and/or radiation therapy to the eye.
2. Evidence of other retinal diseases of the eye, including wet AMD, diabetic retinopathy, diabetic macular edema, or significant vitreomacular traction.
3. Thick media opacity or inability to fixate that precludes obtaining acceptable scans.
4. Concomitant use of hydrochloroquine or chloroquine.
5. Unable to make the required study visits.
6. Unable to give consent or follow study instructions.

Primary outcomes:
measure: Coefficient of variation for area (mm^2) of RPE elevation measurements in the central 3 mm circle.
timeFrame: Single visit observation
Secondary outcomes:
measure: Coefficient of variation for volume (mm^3) of RPE elevation measurements in the central 3 mm circle.
timeFrame: Single visit observation
Other outcomes:
measure: Coefficient of variation for area (mm^2) of RPE elevation measurements in the central 5 mm circle.
timeFrame: Single visit observation
measure: Coefficient of variation for volume (mm^3) of RPE elevation measurements in the central 5 mm circle.
timeFrame: Single visit observation
Locations:
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates
state: California
Study officials:
affiliation: Northern California Retina Vitreous Associates Medical Group, Inc.
name: Mark Wieland, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmitz-Valckenberg S, Fleckenstein M, Scholl HP, Holz FG. Fundus autofluorescence and progression of age-related macular degeneration. Surv Ophthalmol. 2009 Jan-Feb;54(1):96-117. doi: 10.1016/j.survophthal.2008.10.004.