N/A
N=52
Cirrus HD-OCT Measurement of Area of Increased Light Penetration Under the Retinal Pigment Epithelium (RPE)
Age Related Macular Degeneration · Geographic Atrophy
Bottom Line
View on ClinicalTrials.gov: NCT01272076 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcome: Primary: Difference in mm Squared of Cirrus HD-OCT Automated Measurements of the Illumination Areaa Under the RPE to Expert Manual Measurement of Areas of Hypofluorescence Typical of Geographic Atrophy (GA). — 0.1 mm^2
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Carl Zeiss Meditec, Inc.
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in mm Squared of Cirrus HD-OCT Automated Measurements of the Illumination Areaa Under the RPE to Expert Manual Measurement of Areas of Hypofluorescence Typical of Geographic Atrophy (GA). |
0.1 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01272076). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.