Measurement and Analysis of Macular Retinal Pigment Epithelium (RPE) Elevations With Cirrus HD-OCT vs. Color Fundus Photography

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01272063

Enrollment

Registered

2011-01-07

Start date

2010-11-30

Completion date

2011-02-28

Last updated

2013-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drusen Stage Macular Degeneration

Keywords

Drusen, Dry AMD, OCT, Imaging

Brief summary

The objective of this study is to compare the areas designated as elevated retinal pigment epithelium (RPE) by the Cirrus HD-OCT versus those designated as drusen on color fundus photographs (CFPs).

Detailed description

This is a prospective, multiple site study. Ocular history and examination will be conducted on consented subjects to determine further participation in the study. Subjects qualified to continue will undergo color fundus photography and imaging of their study eye using the Cirrus HD-OCT.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

* Males or females 50 years of age or older diagnosed to have dry AMD with macular drusen. * Drusen should not be combined with other lesions such as geographic atrophy (GA) or choroidal neovascularization. * 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 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 visits. * Unable to give consent or follow study instructions.

Design outcomes

Primary

Measure	Time frame
To compare area measurements of elevated RPE as observed in the Cirrus HD-OCT versus those designated as drusen on color fundus photographs.	Study was released before December 1, 2012

Secondary

Measure	Time frame
To describe the clinical factors that affected the automated segmentation of elevated RPE by the Cirrus HD-OCT.	Study was released before December 1, 2012

Other

Measure	Time frame
To describe the qualitative similarities and differences between the areas designated as elevated RPE by the Cirrus HD-OCT versus those designated as drusen on color fundus photographs.	Study was released before December 1, 2012

Countries

United States

Outcome results