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

NCT01890187 | Completed DMC

• 1 other identifier: HD-OCT-GA-2010-2
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Advanced Dry AMD With Geographic Atrophy

Outcome Measures

Primary Outcomes (1)

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

  Single visit observation

Secondary Outcomes (1)

• Coefficient of variation of the closest distance to fovea

  Single visit observation

Study Arms (1)

Advanced dry AMD with geographic atrophy

Patients diagnosed with advanced dry AMD with geographic atrophy

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary Care Clinic

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carl Zeiss Meditec, Inc.: lead
• DataMed Devices Inc.: collaborator

Study Sites (1)

West Coast Retina

Walnut Creek, California, 94107, United States

Location

Study Officials

• Brandon Lujan, MD

  West Coast Retina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: July 1, 2013
• Study Start: November 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: July 1, 2013

Record last verified: 2013-06

Locations

US (1)