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

Advanced Dry AMD With Geographic Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01890187
• Other study ID #: HD-OCT-GA-2010-2
• Status: Completed
• Phase: N/A
• First received: June 24, 2013
• Last updated: June 27, 2013
• Start date: November 2010
• Est. completion date: February 2011

Study information

• Verified date: June 2013
• Source: Carl Zeiss Meditec, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: RCRC Independent Review Board
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Advanced Dry AMD With Geographic Atrophy
• Geographic Atrophy

Locations

Country	Name	City	State
United States	West Coast Retina	Walnut Creek	California

Sponsors (2)

Lead Sponsor	Collaborator
Carl Zeiss Meditec, Inc.	DataMed Devices Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coefficient of variation for area of increased illumination under the RPE (mm^2)		Single visit observation	No
Secondary	Coefficient of variation of the closest distance to fovea		Single visit observation	No